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Q&A with the FDA: Implementing the Pregnancy and Lactation Labeling Rule
In a Q&A with Dr. John Whyte of the Food and Drug Administration, he answers questions on the implementation of the new Pregnancy and...
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.