Teresa Lassman

The Food and Drug Administration has approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA has announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“[Chronic migraine] can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms that resemble botulism. No confirmed reports have been made of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, the agency said.

The Food and Drug Administration has approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA has announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“[Chronic migraine] can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms that resemble botulism. No confirmed reports have been made of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, the agency said.

The Food and Drug Administration has approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA has announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“[Chronic migraine] can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms that resemble botulism. No confirmed reports have been made of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, the agency said.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.

OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.

The most common adverse events reported by this population were neck pain and headache.

Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.

“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.

Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.

Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Therefore, current recommendations suggest that all women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an oral contraceptive for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug.

Previous YAZ clinical trials provided safety and efficacy data for contraception, premenstrual dysphoric disorder, and acne indications for Beyaz.

Side effects most often reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All oral contraceptive users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected to be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Therefore, current recommendations suggest that all women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an oral contraceptive for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug.

Previous YAZ clinical trials provided safety and efficacy data for contraception, premenstrual dysphoric disorder, and acne indications for Beyaz.

Side effects most often reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All oral contraceptive users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected to be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Therefore, current recommendations suggest that all women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an oral contraceptive for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug.

Previous YAZ clinical trials provided safety and efficacy data for contraception, premenstrual dysphoric disorder, and acne indications for Beyaz.

Side effects most often reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All oral contraceptive users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected to be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control.

Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks after discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of combined OCs are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control.

Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks after discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of combined OCs are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, a combined oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, a B vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control.

Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18–40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks after discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of combined OCs are irregular uterine bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration approved Beyaz, an oral contraceptive that contains a folate, on Sept. 24.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration approved Beyaz, an oral contraceptive that contains a folate, on Sept. 24.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration approved Beyaz, an oral contraceptive that contains a folate, on Sept. 24.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin "that helps produce and maintain new cells in the body," according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ's approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, an oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ’s approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, an oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ’s approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.

The Food and Drug Administration on Sept. 24 approved Beyaz, an oral contraceptive that contains a folate.

Levomefolate calcium is a folic acid metabolite, and a B-vitamin “that helps produce and maintain new cells in the body,” according to an FDA announcement. Low folate levels in women of child-bearing age have been associated with neural tube defects, such as spina bifida; current recommendations suggest that women of child-bearing age take supplemental folate.

Beyaz, manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the previously approved oral contraceptive YAZ and contains the same doses of estrogen and progestin (ethinyl estradiol, 20 mcg; drospirenone, 3 mg). Beyaz also contains 0.451 mg of levomefolate calcium.

Beyaz shares YAZ’s approved indications: pregnancy prevention, treatment of premenstrual dysphoric disorder (PMDD) symptoms in women who use OCs for contraception, and treatment of moderate acne in patients aged 14 years and older who have chosen to use an OC for birth control. Beyaz is approved for the secondary indication of raising folate levels to reduce risk of neural tube defects in women who conceive while using the product or shortly after discontinuing it.

A multicenter, double-blind, randomized controlled trial of 379 women aged 18-40 years in the United States who received YAZ or Beyaz for 24 weeks showed that Beyaz increased folate levels. A German study showed that folate levels remained elevated for several weeks following discontinuation of the drug. Previous YAZ clinical trials provided safety and efficacy data for contraception, PMDD, and acne indications for Beyaz.

Side effects most often reported by users of OCs are irregular bleeding, nausea, breast tenderness, and headache. Serious side effects include blood clots and liver disease. All OC users, especially those older than age 35, should not smoke. Side effects of Beyaz are expected be similar to those of YAZ.