User login
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).
Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).
Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.
Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.
MothertoBaby Registry
The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.
The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.
The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.
The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).
The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.
Vaccine registries
A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).
Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: NovartisPregnancyregistries@ppdi.com) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.
Asthma
Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).
GSK registries
GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / belimumab.pregnancy@ppdi.com); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).
Atypical antipsychotics
TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).
TAPP registry
Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).
MPS I registry
The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / help@mpsiregistry.com), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
MPS VI registry
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)
Epilepsy drugs
The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.
Type 2 diabetes
The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.
Renal transplant
Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).
Cymbalta
The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research (pregnancyregistries@incresearch.com / www.cymbaltapregancyregistry.com).
Fabry disease
The Fabry Registry, Genzyme Corp (617-581-5500 / help@FabryRegistry.com) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
MS registry
Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / gpr@outcome.com) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Cancer
The MotHER Pregnancy Registry, INC Research (800-690-6720 / pregnancyregistries@incresearch.com / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).
Merck registries
Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).
The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Hepatitis C
The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ pregnancyregisteries@incresearch.com / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010/ pregnancyresgistries@incresearch.com / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Skin infections
An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).
Pompe disease
Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).
Sleep disorders
Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).
Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).
Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).
Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.
Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.
MothertoBaby Registry
The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.
The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.
The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.
The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).
The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.
Vaccine registries
A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).
Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: NovartisPregnancyregistries@ppdi.com) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.
Asthma
Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).
GSK registries
GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / belimumab.pregnancy@ppdi.com); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).
Atypical antipsychotics
TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).
TAPP registry
Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).
MPS I registry
The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / help@mpsiregistry.com), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
MPS VI registry
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)
Epilepsy drugs
The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.
Type 2 diabetes
The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.
Renal transplant
Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).
Cymbalta
The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research (pregnancyregistries@incresearch.com / www.cymbaltapregancyregistry.com).
Fabry disease
The Fabry Registry, Genzyme Corp (617-581-5500 / help@FabryRegistry.com) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
MS registry
Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / gpr@outcome.com) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Cancer
The MotHER Pregnancy Registry, INC Research (800-690-6720 / pregnancyregistries@incresearch.com / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).
Merck registries
Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).
The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Hepatitis C
The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ pregnancyregisteries@incresearch.com / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010/ pregnancyresgistries@incresearch.com / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Skin infections
An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).
Pompe disease
Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).
Sleep disorders
Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).
Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of human pregnancy experience. The new Food and Drug Administration prescription drug information format may increase the amount of information available, at least from registries conducted by drug manufacturers, because they will be required to list all substantive changes made within the year. Although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of pregnancy registries are their prospective nature and enrollment across a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions).
Registries can identify early signals of teratogenicity, but they have several limitations, including voluntary reporting that results in selection bias, pregnancies lost to follow-up that may have had different outcomes than those with documented outcomes, and a lack of control groups (with some exceptions).
Other limitations are that registry cases are not representative of target populations, and pregnancies lost to follow-up lack details on elective terminations and fetal deaths without birth defects, as well as all spontaneous abortions. Additionally, publication of results may be delayed and does not appear in a peer-reviewed journal.
Since the total number of exposed pregnancies is unknown, registry data cannot be used to calculate prevalence, but can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports, which are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. However, they may be helpful in detecting unusual patterns of birth defects.
MothertoBaby Registry
The large Organization of Teratology Information Specialists (OTIS) MothertoBaby registry (877-311-8972) involves four different categories: autoimmune diseases(rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma; antiviral agents; and vaccines.
The drugs for autoimmune diseases are tocilizumab (Actemra), leflunomide (Arava), teriflunomide (Aubagio), certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), apremilast (Otezla), ustekinumab (Stelara), tofacitinib (Xeljanz), infliximab (Remicade), and methotrexate.
The asthma drugs are formoterol (Foradil, Perforomist, Symbicort, Dulera), albuterol, levalbuterol, metaproterenol, pirbuterol (Maxair), and terbutaline.
The antiviral agents are oseltamivir (Tamiflu) and zanamivir (Relenza).
The vaccines include pertussis (Tdap), seasonal influenza, and meningococcal disease (Menveo). In addition to a control group in each category, a unique aspect of this registry is that many exposed infants will undergo dysmorphology examinations.
Vaccine registries
A second vaccine for meningococcal disease (Menactra) is being studied in the Menactra vaccine Pregnancy Registry (800-822-2463 / www.sanofipasteurpregnancy.com).
Two other registries also include influenza vaccines: Flu vaccine Pregnancy Registry, PPD (Flucelvax) (877-413-4759 / email: NovartisPregnancyregistries@ppdi.com) and the GSK Seasonal Influenza Vaccine Pregnancy Registry, GlaxoSmithKline (888-825-5249 / pregnancyregistry.gsk.com/seasonalinfluenzavaccines.html), which includes the Fluarix and FluLaval vaccines.
Asthma
Women with asthma who are being treated with omalizumab (Xolair) are the target population for the EXPECT Pregnancy Registry (866-496-5247 Option 3 / www.xolairpregnancyregistry.com).
GSK registries
GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / belimumab.pregnancy@ppdi.com); and the Twinrix Pregnancy Registry for women who have received the Twinrix hepatitis A and B vaccine (888-825-5249).
Atypical antipsychotics
TheNational Pregnancy Registry for Atypical Antipsychotics (866-961-2388 / registry@womens mentalhealth.org) is studying 10 drugs: aripiprazole (Abilify), clozapine (Clozaril), iloperidone (Fanapt), paliperidone (Invega), lurasidone (Latuda), risperidone (Risperdal), asenapine (Saphris), quetiapine (Seroquel), ziprasidone (Geodon), and olanzapine (Zyprexa).
TAPP registry
Acitretin is under study by the Take Action to Prevent Pregnancy (T.A.P.P.) registry (855-850-2138 / www.tevagenerics.com/acitretin).
MPS I registry
The MPS I (Mucopolysaccharidosis I) Registry, Genzyme Corp (617-591-5500 / help@mpsiregistry.com), is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
MPS VI registry
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI) Clinical Surveillance Program(415-506-6849 or 415-506-6703)
Epilepsy drugs
The Antiepileptic Drug Pregnancy Registry (888-233-2334 / www.aedpregnancyregistry.org) is studying antiepileptic drugs.
Type 2 diabetes
The Exenatide Pregnancy Registry, conducted by INC Research for AstraZeneca (800-633-9081 / www.exenatidepregnancyregistry.com), examines the use of exenatide (Byetta, Bydureon) for the treatment of type 2 diabetes.
Renal transplant
Renal transplant patients exposed to mycophenolate (Cellcept) can be enrolled in the Mycophenolate Pregnancy Registry (800-617-8191) or the National Transplantation Pregnancy Registry (877-955-6877). The NTPR is enrolling renal transplant patients exposed to belatacept (Nulojix).
Cymbalta
The antidepressant duloxetine (Cymbalta), when used for major depressive or generalized anxiety disorders, diabetic peripheral neuropathic pain, or fibromyalgia is being studied by the Cymbalta Pregnancy Registry, INC Research (pregnancyregistries@incresearch.com / www.cymbaltapregancyregistry.com).
Fabry disease
The Fabry Registry, Genzyme Corp (617-581-5500 / help@FabryRegistry.com) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
MS registry
Novartis Pharmaceuticals is conducting the Gilenya (fingolimod) Pregnancy Registry (877-598-7237 / gpr@outcome.com) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Cancer
The MotHER Pregnancy Registry, INC Research (800-690-6720 / pregnancyregistries@incresearch.com / themotherpregnancyregistry.com) is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab (Kadcyla), trastuzumab (Herceptin), or pertuzumab (Perjeta).
Merck registries
Merck Pregnancy Registries (800-986-8999) include a registry for type 2 diabetes – sitagliptin/metformin (Janumet) or sitagliptin (Januvia) (www.merckpregancyregistries.com/januvia.html); a registry for rizatriptan (Maxalt) (www.merckpregancyregistries.com/maxalt.html), for migraine headaches; and a registry for the 9-valent human papillomavirus (HPV) (Gardasil 9) vaccine (www.merckpregnancyregistries.com/gardasil9.html).
The registry for the asthma drug montelukast (Singulair) and the registry for Gardasil, the quadrivalent HPV vaccine, are now closed to new enrollment, but new cases of pregnancy exposures can be reported to the company at: 877-888-4231.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Hepatitis C
The Ribavirin Pregnancy Registry, INC Research (800-593-2214/ pregnancyregisteries@incresearch.com / ribavirinpregnancyregistry.com) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010/ pregnancyresgistries@incresearch.com / savellapregnancyregistry.com) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Skin infections
An antibacterial, telavancin (Vibativ), indicated for skin infections is being studied by the Vibativ Pregnancy Registry (888-658-4228 / www.clinicaltrial.gov).
Pompe disease
Pregnant women treated with alglucosidase alfa (Myozyme) for Pompe disease can enroll in the Pompe Registry (800-745-4447 x 15500 / www.pompe.com/en/healthcare-professionals/pompe-registry.aspx).
Sleep disorders
Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.nuvigilpregnancyregistry.com). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry (provigilpregnancyregistry.com).
Additional details, including fax numbers and addresses of the registries reviewed above, can be obtained from the FDA website, List of Pregnancy Exposure Registries. Since the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Before retirement, Mr. Briggs was a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; he remains a clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of “Drugs in Pregnancy and Lactation,” and coeditor of “Diseases, Complications, and Drug Therapy in Obstetrics.” He had no relevant financial disclosures. Contact him at obnews@frontlinemedcom.com.
