Pharmacy

Drug vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals and consumers not to use sterile drugs produced by Downing Labs LLC, also known as NuVision Pharmacy, as the products may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile products from NuVision.

Administration of a non-sterile drug product may result in serious and potentially life-threatening infections or death.

NuVision’s products were distributed nationwide. Most of the product labels say, “NuVision Pharmacy, Dallas TX, 75244 1-800-914-7435.”

FDA investigators inspected NuVision and observed unsanitary conditions that result in a lack of sterility assurance of purportedly sterile products, which puts patients at risk.

The inspection revealed sterility failures in 19 lots of products intended to be sterile, endotoxin failures in 3 lots of products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a variety of serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions.

The FDA is not aware of recent reports of illness associated with the use of these products.

Patients who have received any product produced by NuVision and have concerns should contact their healthcare professional.

Healthcare professionals and consumers can report adverse events associated with the use of NuVision’s products to the FDA’s MedWatch Adverse Event Reporting Program.

Drug vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals and consumers not to use sterile drugs produced by Downing Labs LLC, also known as NuVision Pharmacy, as the products may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile products from NuVision.

Administration of a non-sterile drug product may result in serious and potentially life-threatening infections or death.

NuVision’s products were distributed nationwide. Most of the product labels say, “NuVision Pharmacy, Dallas TX, 75244 1-800-914-7435.”

FDA investigators inspected NuVision and observed unsanitary conditions that result in a lack of sterility assurance of purportedly sterile products, which puts patients at risk.

The inspection revealed sterility failures in 19 lots of products intended to be sterile, endotoxin failures in 3 lots of products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a variety of serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions.

The FDA is not aware of recent reports of illness associated with the use of these products.

Patients who have received any product produced by NuVision and have concerns should contact their healthcare professional.

Healthcare professionals and consumers can report adverse events associated with the use of NuVision’s products to the FDA’s MedWatch Adverse Event Reporting Program.

Drug vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals and consumers not to use sterile drugs produced by Downing Labs LLC, also known as NuVision Pharmacy, as the products may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile products from NuVision.

Administration of a non-sterile drug product may result in serious and potentially life-threatening infections or death.

NuVision’s products were distributed nationwide. Most of the product labels say, “NuVision Pharmacy, Dallas TX, 75244 1-800-914-7435.”

FDA investigators inspected NuVision and observed unsanitary conditions that result in a lack of sterility assurance of purportedly sterile products, which puts patients at risk.

The inspection revealed sterility failures in 19 lots of products intended to be sterile, endotoxin failures in 3 lots of products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a variety of serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions.

The FDA is not aware of recent reports of illness associated with the use of these products.

Patients who have received any product produced by NuVision and have concerns should contact their healthcare professional.

Healthcare professionals and consumers can report adverse events associated with the use of NuVision’s products to the FDA’s MedWatch Adverse Event Reporting Program.

octagam 10%

Credit: Octapharma USA

The US Food and Drug Administration (FDA) has approved an intravenous immunoglobulin product (octagam 10%) for the treatment of chronic immune thrombocytopenia (ITP).

The product is a solvent/detergent-treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.

It is intended to raise platelet counts to control or prevent bleeding.

The approval of octagam 10% is based on results of a phase 3 trial (Robak et al, Hematology, Oct. 2010). The trial included 66 patients with chronic ITP and 49 with newly diagnosed ITP.

Among the chronic ITP patients, 81.8% attained the primary efficacy endpoint of clinical response—a platelet count of at least 50×10⁹/L within 7 days of dosing.

Among chronic ITP patients with bleeding at baseline (n=45), 77.7% reported no bleeding at day 7 after treatment.

There were no unexpected tolerability issues, even at the maximum infusion rate of 0.12 mL/kg/minute (720 mg/kg/hour).

The most common treatment-related adverse events in the entire patient cohort were headache (25%), fever (15%), and increased heart rate (11%). The most serious adverse event was headache.

octagam 10% has a black box warning detailing the risk of thrombosis, renal dysfunction, and acute renal failure associated with use of the product. For patients at risk of thrombosis, renal dysfunction, or renal failure, octagam 10% should be given at the minimum infusion rate practicable.

Healthcare providers should ensure adequate hydration in these patients before administering octagam 10%. Providers should also monitor patients for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. The product contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

For more details, see the full prescribing information.

The makers of octagam 10%, Octapharma USA, said the product should be available in the US in September.

octagam 10%

Credit: Octapharma USA

The US Food and Drug Administration (FDA) has approved an intravenous immunoglobulin product (octagam 10%) for the treatment of chronic immune thrombocytopenia (ITP).

The product is a solvent/detergent-treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.

It is intended to raise platelet counts to control or prevent bleeding.

The approval of octagam 10% is based on results of a phase 3 trial (Robak et al, Hematology, Oct. 2010). The trial included 66 patients with chronic ITP and 49 with newly diagnosed ITP.

Among the chronic ITP patients, 81.8% attained the primary efficacy endpoint of clinical response—a platelet count of at least 50×10⁹/L within 7 days of dosing.

Among chronic ITP patients with bleeding at baseline (n=45), 77.7% reported no bleeding at day 7 after treatment.

There were no unexpected tolerability issues, even at the maximum infusion rate of 0.12 mL/kg/minute (720 mg/kg/hour).

The most common treatment-related adverse events in the entire patient cohort were headache (25%), fever (15%), and increased heart rate (11%). The most serious adverse event was headache.

octagam 10% has a black box warning detailing the risk of thrombosis, renal dysfunction, and acute renal failure associated with use of the product. For patients at risk of thrombosis, renal dysfunction, or renal failure, octagam 10% should be given at the minimum infusion rate practicable.

Healthcare providers should ensure adequate hydration in these patients before administering octagam 10%. Providers should also monitor patients for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. The product contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

For more details, see the full prescribing information.

The makers of octagam 10%, Octapharma USA, said the product should be available in the US in September.

octagam 10%

Credit: Octapharma USA

The US Food and Drug Administration (FDA) has approved an intravenous immunoglobulin product (octagam 10%) for the treatment of chronic immune thrombocytopenia (ITP).

The product is a solvent/detergent-treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.

It is intended to raise platelet counts to control or prevent bleeding.

The approval of octagam 10% is based on results of a phase 3 trial (Robak et al, Hematology, Oct. 2010). The trial included 66 patients with chronic ITP and 49 with newly diagnosed ITP.

Among the chronic ITP patients, 81.8% attained the primary efficacy endpoint of clinical response—a platelet count of at least 50×10⁹/L within 7 days of dosing.

Among chronic ITP patients with bleeding at baseline (n=45), 77.7% reported no bleeding at day 7 after treatment.

There were no unexpected tolerability issues, even at the maximum infusion rate of 0.12 mL/kg/minute (720 mg/kg/hour).

The most common treatment-related adverse events in the entire patient cohort were headache (25%), fever (15%), and increased heart rate (11%). The most serious adverse event was headache.

octagam 10% has a black box warning detailing the risk of thrombosis, renal dysfunction, and acute renal failure associated with use of the product. For patients at risk of thrombosis, renal dysfunction, or renal failure, octagam 10% should be given at the minimum infusion rate practicable.

Healthcare providers should ensure adequate hydration in these patients before administering octagam 10%. Providers should also monitor patients for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. The product contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

For more details, see the full prescribing information.

The makers of octagam 10%, Octapharma USA, said the product should be available in the US in September.

Vials of drug

The US Food and Drug Administration (FDA) has approved the first recombinant C1-esterase inhibitor product (Ruconest) for the treatment of acute attacks in adults and adolescents with hereditary angioedema (HAE).

HAE, which is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6000 to 10,000 people in the US.

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks can occur spontaneously or may be triggered by stress, surgery, or infection.

“Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “[The approval of Ruconest] provides an important treatment option for these patients.”

Ruconest is a human recombinant C1-esterase inhibitor purified from the milk of genetically modified rabbits. The product is intended to restore the level of functional C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling.

Trial results have suggested Ruconest is superior to placebo in treating most HAE attacks. However, due to the limited number of patients with laryngeal attacks, Ruconest has not been established as an effective treatment for these attacks.

The FDA approval of Ruconest to treat HAE is based on results of a phase 3, randomized, controlled trial (RCT), which included an open-label extension (OLE) phase, and is supported by the results of 2 additional RCTs and 2 additional OLE studies.

The pivotal RCT and OLE studies included 44 subjects who experienced 170 HAE attacks. The primary efficacy endpoint was the time to the beginning of symptom relief, assessed using patient-reported responses to 2 questions about the change in overall severity of their HAE attack symptoms after the start of treatment.

The researchers assessed these responses at regular time points for each of the affected anatomical locations for up to 24 hours. To achieve the primary endpoint, a patient had to have a positive response to both questions, along with persistence of improvement at the next assessment time (ie, the same or a better response).

There was a statistically significant difference in the time to the beginning of symptom relief in the intent-to-treat population (n=75) between the Ruconest and placebo arms (P=0.031).

The median time to the beginning of symptom relief was 90 minutes for Ruconest-treated patients (n=44) and 152 minutes for placebo-treated patients (n=31).

The most common adverse events, reported in at least 2% of patients receiving Ruconest, were headache, nausea, and diarrhea.

Serious adverse events associated with the treatment include anaphylaxis and arterial and venous thromboembolic events in patients with risk factors, such as an indwelling venous catheter/access device, a prior history of thrombosis, underlying atherosclerosis, the use of oral contraceptives or certain androgens, morbid obesity, and immobility.

Ruconest is manufactured by Pharming Group NV, located in Leiden, the Netherlands, and will be distributed in the US by Santarus Inc., a wholly owned subsidiary of Salix Pharmaceuticals Inc., which is located in Raleigh, North Carolina.

Salix is planning to make Ruconest available to patients later this year.

Vials of drug

The US Food and Drug Administration (FDA) has approved the first recombinant C1-esterase inhibitor product (Ruconest) for the treatment of acute attacks in adults and adolescents with hereditary angioedema (HAE).

HAE, which is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6000 to 10,000 people in the US.

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks can occur spontaneously or may be triggered by stress, surgery, or infection.

“Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “[The approval of Ruconest] provides an important treatment option for these patients.”

Ruconest is a human recombinant C1-esterase inhibitor purified from the milk of genetically modified rabbits. The product is intended to restore the level of functional C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling.

Trial results have suggested Ruconest is superior to placebo in treating most HAE attacks. However, due to the limited number of patients with laryngeal attacks, Ruconest has not been established as an effective treatment for these attacks.

The FDA approval of Ruconest to treat HAE is based on results of a phase 3, randomized, controlled trial (RCT), which included an open-label extension (OLE) phase, and is supported by the results of 2 additional RCTs and 2 additional OLE studies.

The pivotal RCT and OLE studies included 44 subjects who experienced 170 HAE attacks. The primary efficacy endpoint was the time to the beginning of symptom relief, assessed using patient-reported responses to 2 questions about the change in overall severity of their HAE attack symptoms after the start of treatment.

The researchers assessed these responses at regular time points for each of the affected anatomical locations for up to 24 hours. To achieve the primary endpoint, a patient had to have a positive response to both questions, along with persistence of improvement at the next assessment time (ie, the same or a better response).

There was a statistically significant difference in the time to the beginning of symptom relief in the intent-to-treat population (n=75) between the Ruconest and placebo arms (P=0.031).

The median time to the beginning of symptom relief was 90 minutes for Ruconest-treated patients (n=44) and 152 minutes for placebo-treated patients (n=31).

The most common adverse events, reported in at least 2% of patients receiving Ruconest, were headache, nausea, and diarrhea.

Serious adverse events associated with the treatment include anaphylaxis and arterial and venous thromboembolic events in patients with risk factors, such as an indwelling venous catheter/access device, a prior history of thrombosis, underlying atherosclerosis, the use of oral contraceptives or certain androgens, morbid obesity, and immobility.

Ruconest is manufactured by Pharming Group NV, located in Leiden, the Netherlands, and will be distributed in the US by Santarus Inc., a wholly owned subsidiary of Salix Pharmaceuticals Inc., which is located in Raleigh, North Carolina.

Salix is planning to make Ruconest available to patients later this year.

Vials of drug

The US Food and Drug Administration (FDA) has approved the first recombinant C1-esterase inhibitor product (Ruconest) for the treatment of acute attacks in adults and adolescents with hereditary angioedema (HAE).

HAE, which is caused by insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6000 to 10,000 people in the US.

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. These acute attacks can occur spontaneously or may be triggered by stress, surgery, or infection.

“Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “[The approval of Ruconest] provides an important treatment option for these patients.”

Ruconest is a human recombinant C1-esterase inhibitor purified from the milk of genetically modified rabbits. The product is intended to restore the level of functional C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling.

Trial results have suggested Ruconest is superior to placebo in treating most HAE attacks. However, due to the limited number of patients with laryngeal attacks, Ruconest has not been established as an effective treatment for these attacks.

The FDA approval of Ruconest to treat HAE is based on results of a phase 3, randomized, controlled trial (RCT), which included an open-label extension (OLE) phase, and is supported by the results of 2 additional RCTs and 2 additional OLE studies.

The pivotal RCT and OLE studies included 44 subjects who experienced 170 HAE attacks. The primary efficacy endpoint was the time to the beginning of symptom relief, assessed using patient-reported responses to 2 questions about the change in overall severity of their HAE attack symptoms after the start of treatment.

The researchers assessed these responses at regular time points for each of the affected anatomical locations for up to 24 hours. To achieve the primary endpoint, a patient had to have a positive response to both questions, along with persistence of improvement at the next assessment time (ie, the same or a better response).

There was a statistically significant difference in the time to the beginning of symptom relief in the intent-to-treat population (n=75) between the Ruconest and placebo arms (P=0.031).

The median time to the beginning of symptom relief was 90 minutes for Ruconest-treated patients (n=44) and 152 minutes for placebo-treated patients (n=31).

The most common adverse events, reported in at least 2% of patients receiving Ruconest, were headache, nausea, and diarrhea.

Serious adverse events associated with the treatment include anaphylaxis and arterial and venous thromboembolic events in patients with risk factors, such as an indwelling venous catheter/access device, a prior history of thrombosis, underlying atherosclerosis, the use of oral contraceptives or certain androgens, morbid obesity, and immobility.

Ruconest is manufactured by Pharming Group NV, located in Leiden, the Netherlands, and will be distributed in the US by Santarus Inc., a wholly owned subsidiary of Salix Pharmaceuticals Inc., which is located in Raleigh, North Carolina.

Salix is planning to make Ruconest available to patients later this year.

Drugs in vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use sterile drugs produced by Unique Pharmaceuticals Ltd., as they may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals, a compounding outsourcing facility in Temple, Texas.

Administration of a non-sterile product may result in serious infection or death.

Unique Pharmaceuticals’ products were distributed nationwide. Most of the product labels include: “Unique Pharmaceuticals, Temple TX USA 76502.”

FDA investigators conducted 2 recent inspections of the Unique Pharmaceuticals facility and observed unsanitary conditions that resulted in a lack of sterility assurance.

The inspections revealed sterility failures in several lots of products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

The FDA previously asked the company to recall all non-expired lots of sterile drug products, but the company refused to do so. The FDA has now issued a formal request for Unique Pharmaceuticals to recall all non-expired lots of its sterile products currently on the market.

The FDA has also asked the company to cease sterile compounding operations until sufficient corrections are made at its facility. Unique Pharmaceuticals has refused this request as well.

To date, the FDA is not aware of reports of illness associated with the use of Unique Pharmaceuticals’ products.

Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their healthcare professional.

Professionals and consumers may report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting Program.

Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility.

Outsourcing facilities must comply with current good manufacturing practice requirements, will be subject to inspection by the FDA according to a risk-based schedule, and must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

Drugs in vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use sterile drugs produced by Unique Pharmaceuticals Ltd., as they may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals, a compounding outsourcing facility in Temple, Texas.

Administration of a non-sterile product may result in serious infection or death.

Unique Pharmaceuticals’ products were distributed nationwide. Most of the product labels include: “Unique Pharmaceuticals, Temple TX USA 76502.”

FDA investigators conducted 2 recent inspections of the Unique Pharmaceuticals facility and observed unsanitary conditions that resulted in a lack of sterility assurance.

The inspections revealed sterility failures in several lots of products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

The FDA previously asked the company to recall all non-expired lots of sterile drug products, but the company refused to do so. The FDA has now issued a formal request for Unique Pharmaceuticals to recall all non-expired lots of its sterile products currently on the market.

The FDA has also asked the company to cease sterile compounding operations until sufficient corrections are made at its facility. Unique Pharmaceuticals has refused this request as well.

To date, the FDA is not aware of reports of illness associated with the use of Unique Pharmaceuticals’ products.

Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their healthcare professional.

Professionals and consumers may report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting Program.

Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility.

Outsourcing facilities must comply with current good manufacturing practice requirements, will be subject to inspection by the FDA according to a risk-based schedule, and must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

Drugs in vials

Credit: Bill Branson

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use sterile drugs produced by Unique Pharmaceuticals Ltd., as they may be contaminated.

Healthcare professionals should immediately check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals, a compounding outsourcing facility in Temple, Texas.

Administration of a non-sterile product may result in serious infection or death.

Unique Pharmaceuticals’ products were distributed nationwide. Most of the product labels include: “Unique Pharmaceuticals, Temple TX USA 76502.”

FDA investigators conducted 2 recent inspections of the Unique Pharmaceuticals facility and observed unsanitary conditions that resulted in a lack of sterility assurance.

The inspections revealed sterility failures in several lots of products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

The FDA previously asked the company to recall all non-expired lots of sterile drug products, but the company refused to do so. The FDA has now issued a formal request for Unique Pharmaceuticals to recall all non-expired lots of its sterile products currently on the market.

The FDA has also asked the company to cease sterile compounding operations until sufficient corrections are made at its facility. Unique Pharmaceuticals has refused this request as well.

To date, the FDA is not aware of reports of illness associated with the use of Unique Pharmaceuticals’ products.

Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their healthcare professional.

Professionals and consumers may report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting Program.

Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility.

Outsourcing facilities must comply with current good manufacturing practice requirements, will be subject to inspection by the FDA according to a risk-based schedule, and must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

Recalled product

Image courtesy of Hospira

Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).

The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.

An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.

Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.

However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.

Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.

This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.

For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or medcom@hospira.com.

To report adverse events or product complaints, contact Hospira Global

Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or

medcom@hospira.com.

Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Recalled product

Image courtesy of Hospira

Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).

The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.

An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.

Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.

However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.

Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.

This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.

For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or medcom@hospira.com.

To report adverse events or product complaints, contact Hospira Global

Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or

medcom@hospira.com.

Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Recalled product

Image courtesy of Hospira

Hospira, Inc., has announced a US-wide, user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container (NDC 0409-7929-09, Lot 35-118-JT).

The company confirmed a report of particulate within the solution of the primary container. It was a filamentous-like structured particulate indicative of mold.

An analysis of the primary container and overwrap revealed a puncture that had caused the container to leak.

Intravenous administration of a non-sterile product can result in infections that may be life-threatening and could result in prolonged hospitalization or organ failure.

However, Hospira has not received reports of any adverse events associated with this issue for this lot and has not identified any quality issues with retention samples for this lot.

Lactated Ringers and 5% Dextrose Injection is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container.

This lot (35-118-JT) was distributed nationwide—from December 2013 through February 2014—to hospitals, clinics, wholesalers, and distributors.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 (8am to 5pm EST, Monday through Friday) to arrange for the return of the product.

For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 (available 24 hours a day, 7 days per week) or medcom@hospira.com.

To report adverse events or product complaints, contact Hospira Global

Complaint Management at 1-800-441-4100 (8am to 5pm CT, Monday through Friday) or

medcom@hospira.com.

Adverse events or quality problems can also be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program.

Team performing surgery

Credit: Piotr Bodzek

The US Food and Drug Administration (FDA) has approved a recombinant factor VIIa product (NovoSeven® RT) for the treatment of bleeding episodes and for perioperative management in patients with Glanzmann’s Thrombasthenia (GT) who are refractory to platelet transfusions and may or may not have antibodies to platelets.

GT is a rare genetic bleeding disorder with limited treatment options. Patients with GT have a lifelong susceptibility toward bleeding episodes.

The condition, which affects 1 in 1 million people globally, occurs because certain surface proteins on platelets are missing or nonfunctional, significantly impacting the blood’s ability to form strong clots.

Patients with GT typically receive platelet transfusions when experiencing severe bleeding or when undergoing surgical procedures. However, some patients do not respond well, or at all, to platelet transfusions.

The FDA approved NovoSeven® RT for these patients based on evidence collected from the global Glanzmann’s Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry.

The data included 92 GT patients treated with NovoSeven® RT for 266 severe bleeding episodes and 77 GT patients treated with NovoSeven® RT for 160 surgical and other invasive procedures.

The treatment was successful in 94.4% of bleeding episodes and 99.4% of surgical procedures, based on a review of the data by independent hematology experts.

Among 140 patients treated for 518 bleeding episodes, surgeries, or traumatic injuries, the following adverse events were reported: deep vein thrombosis (n=1), headache (n=2), fever (n=2), nausea (n=1), and dyspnea (n=1).

NovoSeven® RT is also approved in the European Union for the treatment of bleeding episodes in patients with GT. The product is marketed by NovoNordisk.

Team performing surgery

Credit: Piotr Bodzek

The US Food and Drug Administration (FDA) has approved a recombinant factor VIIa product (NovoSeven® RT) for the treatment of bleeding episodes and for perioperative management in patients with Glanzmann’s Thrombasthenia (GT) who are refractory to platelet transfusions and may or may not have antibodies to platelets.

GT is a rare genetic bleeding disorder with limited treatment options. Patients with GT have a lifelong susceptibility toward bleeding episodes.

The condition, which affects 1 in 1 million people globally, occurs because certain surface proteins on platelets are missing or nonfunctional, significantly impacting the blood’s ability to form strong clots.

Patients with GT typically receive platelet transfusions when experiencing severe bleeding or when undergoing surgical procedures. However, some patients do not respond well, or at all, to platelet transfusions.

The FDA approved NovoSeven® RT for these patients based on evidence collected from the global Glanzmann’s Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry.

The data included 92 GT patients treated with NovoSeven® RT for 266 severe bleeding episodes and 77 GT patients treated with NovoSeven® RT for 160 surgical and other invasive procedures.

The treatment was successful in 94.4% of bleeding episodes and 99.4% of surgical procedures, based on a review of the data by independent hematology experts.

Among 140 patients treated for 518 bleeding episodes, surgeries, or traumatic injuries, the following adverse events were reported: deep vein thrombosis (n=1), headache (n=2), fever (n=2), nausea (n=1), and dyspnea (n=1).

NovoSeven® RT is also approved in the European Union for the treatment of bleeding episodes in patients with GT. The product is marketed by NovoNordisk.

Team performing surgery

Credit: Piotr Bodzek

The US Food and Drug Administration (FDA) has approved a recombinant factor VIIa product (NovoSeven® RT) for the treatment of bleeding episodes and for perioperative management in patients with Glanzmann’s Thrombasthenia (GT) who are refractory to platelet transfusions and may or may not have antibodies to platelets.

GT is a rare genetic bleeding disorder with limited treatment options. Patients with GT have a lifelong susceptibility toward bleeding episodes.

The condition, which affects 1 in 1 million people globally, occurs because certain surface proteins on platelets are missing or nonfunctional, significantly impacting the blood’s ability to form strong clots.

Patients with GT typically receive platelet transfusions when experiencing severe bleeding or when undergoing surgical procedures. However, some patients do not respond well, or at all, to platelet transfusions.

The FDA approved NovoSeven® RT for these patients based on evidence collected from the global Glanzmann’s Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry.

The data included 92 GT patients treated with NovoSeven® RT for 266 severe bleeding episodes and 77 GT patients treated with NovoSeven® RT for 160 surgical and other invasive procedures.

The treatment was successful in 94.4% of bleeding episodes and 99.4% of surgical procedures, based on a review of the data by independent hematology experts.

Among 140 patients treated for 518 bleeding episodes, surgeries, or traumatic injuries, the following adverse events were reported: deep vein thrombosis (n=1), headache (n=2), fever (n=2), nausea (n=1), and dyspnea (n=1).

NovoSeven® RT is also approved in the European Union for the treatment of bleeding episodes in patients with GT. The product is marketed by NovoNordisk.

Photo from Penn Medicine

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the T-cell therapy CTL019 to treat adults and children with relapsed or refractory acute lymphoblastic leukemia (ALL).

The therapy consists of a patient’s own T cells genetically engineered to produce chimeric antigen receptors (CARs) directed against CD19.

CTL019 is the first personalized cellular therapy for cancer to receive breakthrough designation from the FDA.

Breakthrough designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over available therapies.

The breakthrough designation for CTL019 is based on early trial results in adults and children with ALL.

At ASH 2013, researchers presented results of the first 27 ALL patients (22 children and 5 adults) treated with CTL019. Eighty-nine percent of the patients achieved a complete response to the treatment. Six patients relapsed during follow-up, which ranged from 2 months to 18 months.

There was also a high rate of toxicity, particularly cytokine release syndrome, but this was resolved via treatment with the IL-6 agonist tocilizumab.

The first pediatric ALL patient to receive CTL019 celebrated the second anniversary of her cancer remission in May. And the first adult patient remains in remission 1 year after receiving the therapy.

“Our early findings reveal tremendous promise for a desperate group of patients, many of whom have been able to return to their normal lives at school and work after receiving this new, personalized immunotherapy,” said Carl June, MD, of the University of Pennsylvania.

“Receiving the FDA’s breakthrough designation is an essential step in our work with Novartis to expand this therapy to patients across the world who desperately need new options to help them fight this disease.”

In August 2012, the University of Pennsylvania announced an exclusive global research and licensing agreement with Novartis to further study, develop, and commercialize personalized CAR T-cell therapies for the treatment of cancers.

Trials of CTL019 began in the summer of 2010 in patients with relapsed and refractory chronic lymphocytic leukemia, and they are now underway for patients with ALL, non-Hodgkin lymphoma, and myeloma.

CTL019 cells are a patients’ own T cells genetically engineered to express an anti-CD19 scFv coupled to CD3ζ signaling and 4-1BB co-stimulatory domains. The cells are activated and expanded ex vivo with anti-CD3 and anti-CD28 beads, then infused into patients.

Photo from Penn Medicine

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the T-cell therapy CTL019 to treat adults and children with relapsed or refractory acute lymphoblastic leukemia (ALL).

The therapy consists of a patient’s own T cells genetically engineered to produce chimeric antigen receptors (CARs) directed against CD19.

CTL019 is the first personalized cellular therapy for cancer to receive breakthrough designation from the FDA.

Breakthrough designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over available therapies.

The breakthrough designation for CTL019 is based on early trial results in adults and children with ALL.

At ASH 2013, researchers presented results of the first 27 ALL patients (22 children and 5 adults) treated with CTL019. Eighty-nine percent of the patients achieved a complete response to the treatment. Six patients relapsed during follow-up, which ranged from 2 months to 18 months.

There was also a high rate of toxicity, particularly cytokine release syndrome, but this was resolved via treatment with the IL-6 agonist tocilizumab.

The first pediatric ALL patient to receive CTL019 celebrated the second anniversary of her cancer remission in May. And the first adult patient remains in remission 1 year after receiving the therapy.

“Our early findings reveal tremendous promise for a desperate group of patients, many of whom have been able to return to their normal lives at school and work after receiving this new, personalized immunotherapy,” said Carl June, MD, of the University of Pennsylvania.

“Receiving the FDA’s breakthrough designation is an essential step in our work with Novartis to expand this therapy to patients across the world who desperately need new options to help them fight this disease.”

In August 2012, the University of Pennsylvania announced an exclusive global research and licensing agreement with Novartis to further study, develop, and commercialize personalized CAR T-cell therapies for the treatment of cancers.

Trials of CTL019 began in the summer of 2010 in patients with relapsed and refractory chronic lymphocytic leukemia, and they are now underway for patients with ALL, non-Hodgkin lymphoma, and myeloma.

CTL019 cells are a patients’ own T cells genetically engineered to express an anti-CD19 scFv coupled to CD3ζ signaling and 4-1BB co-stimulatory domains. The cells are activated and expanded ex vivo with anti-CD3 and anti-CD28 beads, then infused into patients.

Photo from Penn Medicine

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the T-cell therapy CTL019 to treat adults and children with relapsed or refractory acute lymphoblastic leukemia (ALL).

The therapy consists of a patient’s own T cells genetically engineered to produce chimeric antigen receptors (CARs) directed against CD19.

CTL019 is the first personalized cellular therapy for cancer to receive breakthrough designation from the FDA.

Breakthrough designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over available therapies.

The breakthrough designation for CTL019 is based on early trial results in adults and children with ALL.

At ASH 2013, researchers presented results of the first 27 ALL patients (22 children and 5 adults) treated with CTL019. Eighty-nine percent of the patients achieved a complete response to the treatment. Six patients relapsed during follow-up, which ranged from 2 months to 18 months.

There was also a high rate of toxicity, particularly cytokine release syndrome, but this was resolved via treatment with the IL-6 agonist tocilizumab.

The first pediatric ALL patient to receive CTL019 celebrated the second anniversary of her cancer remission in May. And the first adult patient remains in remission 1 year after receiving the therapy.

“Our early findings reveal tremendous promise for a desperate group of patients, many of whom have been able to return to their normal lives at school and work after receiving this new, personalized immunotherapy,” said Carl June, MD, of the University of Pennsylvania.

“Receiving the FDA’s breakthrough designation is an essential step in our work with Novartis to expand this therapy to patients across the world who desperately need new options to help them fight this disease.”

In August 2012, the University of Pennsylvania announced an exclusive global research and licensing agreement with Novartis to further study, develop, and commercialize personalized CAR T-cell therapies for the treatment of cancers.

Trials of CTL019 began in the summer of 2010 in patients with relapsed and refractory chronic lymphocytic leukemia, and they are now underway for patients with ALL, non-Hodgkin lymphoma, and myeloma.

CTL019 cells are a patients’ own T cells genetically engineered to express an anti-CD19 scFv coupled to CD3ζ signaling and 4-1BB co-stimulatory domains. The cells are activated and expanded ex vivo with anti-CD3 and anti-CD28 beads, then infused into patients.

Monoclonal antibodies

Credit: Linda Bartlett

The European Commission (EC) has expanded the indication for the anti-CD20 monoclonal antibody ofatumumab (Arzerra).

The EC granted conditional approval for ofatumumab in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

In 2010, the EC granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. Ofatumumab will not receive full approval until the drug’s developers, GlaxoSmithKline and GenMab, submit results of additional research to the EC.

Trial results

The EC’s new approval of ofatumumab, for previously untreated CLL patients, is based on results from 2 trials, COMPLEMENT 1 and OMB115991.

The phase 3 COMPLEMENT 1 trial was a comparison of ofatumumab plus chlorambucil (n=221) with chlorambucil alone (n=226) in CLL patients for whom fludarabine-based treatment was considered inappropriate.

In this study, ofatumumab plus chlorambucil improved progression-free survival compared to chlorambucil alone. The median times were 22.4 months and 13.1 months, respectively, and the hazard ratio was 0.57 (P<0.001).

In the phase 2 trial known as OMB115991, researchers evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate.

The combination elicited an overall response rate of 95% and a complete response rate of 43%.

The overall safety profile of ofatumumab in CLL (previously untreated and relapsed/refractory) is based on data from 511 patients in clinical trials.

This includes 250 patients with relapsed/refractory CLL who were treated with ofatumumab alone and 261 patients with previously untreated CLL who were treated in combination with an alkylating agent.

The most common adverse effects associated with ofatumumab were infusion reactions, neutropenia, anemia, febrile neutropenia, thrombocytopenia, leukopenia, lower respiratory tract infection (including pneumonia), upper respiratory tract infection, sepsis (including neutropenic sepsis and septic shock), herpes virus infection, and urinary tract infection.

Monoclonal antibodies

Credit: Linda Bartlett

The European Commission (EC) has expanded the indication for the anti-CD20 monoclonal antibody ofatumumab (Arzerra).

The EC granted conditional approval for ofatumumab in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

In 2010, the EC granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. Ofatumumab will not receive full approval until the drug’s developers, GlaxoSmithKline and GenMab, submit results of additional research to the EC.

Trial results

The EC’s new approval of ofatumumab, for previously untreated CLL patients, is based on results from 2 trials, COMPLEMENT 1 and OMB115991.

The phase 3 COMPLEMENT 1 trial was a comparison of ofatumumab plus chlorambucil (n=221) with chlorambucil alone (n=226) in CLL patients for whom fludarabine-based treatment was considered inappropriate.

In this study, ofatumumab plus chlorambucil improved progression-free survival compared to chlorambucil alone. The median times were 22.4 months and 13.1 months, respectively, and the hazard ratio was 0.57 (P<0.001).

In the phase 2 trial known as OMB115991, researchers evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate.

The combination elicited an overall response rate of 95% and a complete response rate of 43%.

The overall safety profile of ofatumumab in CLL (previously untreated and relapsed/refractory) is based on data from 511 patients in clinical trials.

This includes 250 patients with relapsed/refractory CLL who were treated with ofatumumab alone and 261 patients with previously untreated CLL who were treated in combination with an alkylating agent.

The most common adverse effects associated with ofatumumab were infusion reactions, neutropenia, anemia, febrile neutropenia, thrombocytopenia, leukopenia, lower respiratory tract infection (including pneumonia), upper respiratory tract infection, sepsis (including neutropenic sepsis and septic shock), herpes virus infection, and urinary tract infection.

Monoclonal antibodies

Credit: Linda Bartlett

The European Commission (EC) has expanded the indication for the anti-CD20 monoclonal antibody ofatumumab (Arzerra).

The EC granted conditional approval for ofatumumab in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are not eligible for fludarabine-based therapy.

In 2010, the EC granted ofatumumab conditional approval to treat CLL patients who are refractory to fludarabine and alemtuzumab.

Ofatumumab received conditional approval because the drug’s benefits appear to outweigh the risks it poses. Ofatumumab will not receive full approval until the drug’s developers, GlaxoSmithKline and GenMab, submit results of additional research to the EC.

Trial results

The EC’s new approval of ofatumumab, for previously untreated CLL patients, is based on results from 2 trials, COMPLEMENT 1 and OMB115991.

The phase 3 COMPLEMENT 1 trial was a comparison of ofatumumab plus chlorambucil (n=221) with chlorambucil alone (n=226) in CLL patients for whom fludarabine-based treatment was considered inappropriate.

In this study, ofatumumab plus chlorambucil improved progression-free survival compared to chlorambucil alone. The median times were 22.4 months and 13.1 months, respectively, and the hazard ratio was 0.57 (P<0.001).

In the phase 2 trial known as OMB115991, researchers evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate.

The combination elicited an overall response rate of 95% and a complete response rate of 43%.

The overall safety profile of ofatumumab in CLL (previously untreated and relapsed/refractory) is based on data from 511 patients in clinical trials.

This includes 250 patients with relapsed/refractory CLL who were treated with ofatumumab alone and 261 patients with previously untreated CLL who were treated in combination with an alkylating agent.

The most common adverse effects associated with ofatumumab were infusion reactions, neutropenia, anemia, febrile neutropenia, thrombocytopenia, leukopenia, lower respiratory tract infection (including pneumonia), upper respiratory tract infection, sepsis (including neutropenic sepsis and septic shock), herpes virus infection, and urinary tract infection.

The US Food and Drug Administration (FDA) has granted accelerated approval for belinostat (Beleodaq) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Belinostat is a histone deacetylase inhibitor with antineoplastic activity. The drug works by inhibiting tumor cell proliferation, inducing apoptosis, promoting cellular differentiation, and inhibiting angiogenesis.

The FDA’s accelerated approval program allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs.

Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit.

The FDA granted belinostat accelerated approval based on results of a phase 2 trial, which included 129 patients with relapsed or refractory PTCL. All patients received belinostat until disease progression or unacceptable toxicity.

About 26% of patients achieved a complete or partial response. The most common side effects were nausea, fatigue, pyrexia, anemia, and vomiting.

“[Belinostat] is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted accelerated approval to pralatrexate (Folotyn) in 2009 for use in patients with relapsed or refractory PTCL and romidepsin (Istodax) in 2011 for PTCL patients who had received at least 1 prior therapy.

Beleodaq and Folotyn are marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada. Istodax is marketed by Celgene Corporation based in Summit, New Jersey.

The US Food and Drug Administration (FDA) has granted accelerated approval for belinostat (Beleodaq) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Belinostat is a histone deacetylase inhibitor with antineoplastic activity. The drug works by inhibiting tumor cell proliferation, inducing apoptosis, promoting cellular differentiation, and inhibiting angiogenesis.

The FDA’s accelerated approval program allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs.

Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit.

The FDA granted belinostat accelerated approval based on results of a phase 2 trial, which included 129 patients with relapsed or refractory PTCL. All patients received belinostat until disease progression or unacceptable toxicity.

About 26% of patients achieved a complete or partial response. The most common side effects were nausea, fatigue, pyrexia, anemia, and vomiting.

“[Belinostat] is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted accelerated approval to pralatrexate (Folotyn) in 2009 for use in patients with relapsed or refractory PTCL and romidepsin (Istodax) in 2011 for PTCL patients who had received at least 1 prior therapy.

Beleodaq and Folotyn are marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada. Istodax is marketed by Celgene Corporation based in Summit, New Jersey.

The US Food and Drug Administration (FDA) has granted accelerated approval for belinostat (Beleodaq) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Belinostat is a histone deacetylase inhibitor with antineoplastic activity. The drug works by inhibiting tumor cell proliferation, inducing apoptosis, promoting cellular differentiation, and inhibiting angiogenesis.

The FDA’s accelerated approval program allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs.

Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit.

The FDA granted belinostat accelerated approval based on results of a phase 2 trial, which included 129 patients with relapsed or refractory PTCL. All patients received belinostat until disease progression or unacceptable toxicity.

About 26% of patients achieved a complete or partial response. The most common side effects were nausea, fatigue, pyrexia, anemia, and vomiting.

“[Belinostat] is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA granted accelerated approval to pralatrexate (Folotyn) in 2009 for use in patients with relapsed or refractory PTCL and romidepsin (Istodax) in 2011 for PTCL patients who had received at least 1 prior therapy.

Beleodaq and Folotyn are marketed by Spectrum Pharmaceuticals, Inc., based in Henderson, Nevada. Istodax is marketed by Celgene Corporation based in Summit, New Jersey.

Prescription medications

Credit: CDC

A new study indicates that a fair share of patients may be mixing the herbal supplement St. John’s wort with prescribed medications, which can have dangerous results.

St. John’s wort can reduce the concentration of numerous drugs in the body, including anticoagulants and chemotherapeutic agents. And this can result in impaired effectiveness and treatment failure.

But the supplement can also interact with medications to produce serious adverse events.

“Patients may have a false sense of safety with so-called ‘natural’ treatments like St. John’s wort,” said study author Sarah Taylor, MD, of Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.

“And it is crucial for physicians to know the dangers of ‘natural’ treatments and to communicate the risks to patients effectively.”

Dr Taylor and her colleagues investigated the use of St. John’s wort and reported their findings in The Journal of Alternative and Complementary Medicine.

To determine how often the supplement was being prescribed or taken with other medications, the researchers conducted a retrospective analysis of nationally representative data collected by the National Ambulatory Medical Care Survey from 1993 to 2010.

The team found the use of St. John’s wort in potentially harmful combinations in 28% of the cases reviewed. The drugs involved were warfarin, selective serotonin reuptake inhibitors, benzodiazepines, statins, verapamil, digoxin, and oral contraceptives.

Possible drug interactions include serotonin syndrome (a potentially fatal condition that causes high levels of the chemical serotonin to accumulate in the body), heart disease due to impaired efficacy of blood pressure medications, or unplanned pregnancy due to contraceptive failure, Dr Taylor said.

A key limitation of this study is that only medications recorded by the physician were analyzed. And Dr Taylor said the rate of St. John’s wort interactions may actually be underestimated because the database did not include patients who were using St. John’s wort but did not tell their doctor.

“Labeling requirements for helpful supplements such as St. John’s wort need to provide appropriate cautions and risk information,” Dr Taylor said, adding that France has banned the use of St. John’s wort products, and several other countries, including Japan, the UK, and Canada, are in the process of including drug-herb interaction warnings on St. John’s wort products.

“Doctors also need to be trained to always ask if the patient is taking any supplements, vitamins, minerals or herbs, especially before prescribing any of the common drugs that might interact with St. John’s wort.”

Prescription medications

Credit: CDC

A new study indicates that a fair share of patients may be mixing the herbal supplement St. John’s wort with prescribed medications, which can have dangerous results.

St. John’s wort can reduce the concentration of numerous drugs in the body, including anticoagulants and chemotherapeutic agents. And this can result in impaired effectiveness and treatment failure.

But the supplement can also interact with medications to produce serious adverse events.

“Patients may have a false sense of safety with so-called ‘natural’ treatments like St. John’s wort,” said study author Sarah Taylor, MD, of Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.

“And it is crucial for physicians to know the dangers of ‘natural’ treatments and to communicate the risks to patients effectively.”

Dr Taylor and her colleagues investigated the use of St. John’s wort and reported their findings in The Journal of Alternative and Complementary Medicine.

To determine how often the supplement was being prescribed or taken with other medications, the researchers conducted a retrospective analysis of nationally representative data collected by the National Ambulatory Medical Care Survey from 1993 to 2010.

The team found the use of St. John’s wort in potentially harmful combinations in 28% of the cases reviewed. The drugs involved were warfarin, selective serotonin reuptake inhibitors, benzodiazepines, statins, verapamil, digoxin, and oral contraceptives.

Possible drug interactions include serotonin syndrome (a potentially fatal condition that causes high levels of the chemical serotonin to accumulate in the body), heart disease due to impaired efficacy of blood pressure medications, or unplanned pregnancy due to contraceptive failure, Dr Taylor said.

A key limitation of this study is that only medications recorded by the physician were analyzed. And Dr Taylor said the rate of St. John’s wort interactions may actually be underestimated because the database did not include patients who were using St. John’s wort but did not tell their doctor.

“Labeling requirements for helpful supplements such as St. John’s wort need to provide appropriate cautions and risk information,” Dr Taylor said, adding that France has banned the use of St. John’s wort products, and several other countries, including Japan, the UK, and Canada, are in the process of including drug-herb interaction warnings on St. John’s wort products.

“Doctors also need to be trained to always ask if the patient is taking any supplements, vitamins, minerals or herbs, especially before prescribing any of the common drugs that might interact with St. John’s wort.”

Prescription medications

Credit: CDC

A new study indicates that a fair share of patients may be mixing the herbal supplement St. John’s wort with prescribed medications, which can have dangerous results.

St. John’s wort can reduce the concentration of numerous drugs in the body, including anticoagulants and chemotherapeutic agents. And this can result in impaired effectiveness and treatment failure.

But the supplement can also interact with medications to produce serious adverse events.

“Patients may have a false sense of safety with so-called ‘natural’ treatments like St. John’s wort,” said study author Sarah Taylor, MD, of Wake Forest Baptist Medical Center in Winston-Salem, North Carolina.

“And it is crucial for physicians to know the dangers of ‘natural’ treatments and to communicate the risks to patients effectively.”

Dr Taylor and her colleagues investigated the use of St. John’s wort and reported their findings in The Journal of Alternative and Complementary Medicine.

To determine how often the supplement was being prescribed or taken with other medications, the researchers conducted a retrospective analysis of nationally representative data collected by the National Ambulatory Medical Care Survey from 1993 to 2010.

The team found the use of St. John’s wort in potentially harmful combinations in 28% of the cases reviewed. The drugs involved were warfarin, selective serotonin reuptake inhibitors, benzodiazepines, statins, verapamil, digoxin, and oral contraceptives.

Possible drug interactions include serotonin syndrome (a potentially fatal condition that causes high levels of the chemical serotonin to accumulate in the body), heart disease due to impaired efficacy of blood pressure medications, or unplanned pregnancy due to contraceptive failure, Dr Taylor said.

A key limitation of this study is that only medications recorded by the physician were analyzed. And Dr Taylor said the rate of St. John’s wort interactions may actually be underestimated because the database did not include patients who were using St. John’s wort but did not tell their doctor.

“Labeling requirements for helpful supplements such as St. John’s wort need to provide appropriate cautions and risk information,” Dr Taylor said, adding that France has banned the use of St. John’s wort products, and several other countries, including Japan, the UK, and Canada, are in the process of including drug-herb interaction warnings on St. John’s wort products.

“Doctors also need to be trained to always ask if the patient is taking any supplements, vitamins, minerals or herbs, especially before prescribing any of the common drugs that might interact with St. John’s wort.”