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Registries Help Moms Measure Medication Risk

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Congress gave FDA the authority to require drug makers to study the effects of newly approved medicines on pregnant and nursing women and newborn infants in the FDA Amendments Act of 2007.

Under the law, FDA experts also review applications for new drugs and decide if the manufacturer should be required to set up a pregnancy registry after approval, says Feibus.

Sometimes health professionals or the drug industry begin a registry without being required to do so—as in the case of the North American Antiepileptic Drug Pregnancy Registry, which studies the effects of drugs for the treatment of epilepsy.

Pregnant women with epilepsy are recruited to participate because they must take medicines to control seizures. The Epilepsy Foundation encourages women to enroll in the registry, which is closely monitored by researchers at Massachusetts General Hospital, the teaching hospital for Harvard University Medical School.

“By enrolling, you will help women in the future have the best chance of a healthy pregnancy and a healthy baby,” the foundation tells expectant moms in a message on its website.

In May 2008, FDA proposed a new rule that includes putting information learned from registries—as well as contact information for registries—on labeling for health professionals. The final rule will be published at the end of a multi-stepped writing and clearance process.

Registries Aid Moms, Babies

FDA says the registries protect the health of mothers and babies because

  • many pregnant women have ongoing medical issues that require them to continue taking drugs during pregnancy
  • new medical problems may begin or old ones may get worse
  • a woman's body changes during pregnancy and the changes may affect the dosage of a medication she is taking
  • a woman often takes medications while she is breastfeeding, potentially exposing her baby to the effects of medicines
  • about half of the 6 million pregnancies in the United States each year are unplanned, exposing women and developing babies to drugs before they know they are pregnant

Registries typically collect the woman’s demographics and medications being taken. Massachusetts General in Boston lists more than 30 medications being studied, and promises the process will be quick: one 20-minute phone call at the beginning and two five-minute calls after that.

In most instances, a woman can participate in a pregnancy registry by contacting the drug’s maker, her physician, or pharmacist.

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).   

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