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FDA Studies Safe Drugs During Pregnancy

Posted by Jane Akre
Monday, January 04, 2010 10:48 AM EST
Category: Protecting Your Family
Tags: Pregnancy, Women's Health, Unborn, Fetus, Prescription Medication

The effects of drugs on pregnancy will be studied at 11 centers working with the FDA.

Safe Drugs During Pregnancy


IMAGE SOURCE:© iStockphoto/ pregnant woman / author: Aldomurillo

It’s always been a question for pregnant women – which medications are safe to take for them and their unborn child.

The U.S. Food and Drug Administration will study the safety of medications with the aim off compiling reliable data for doctors to use when they prescribe.

The project is called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP).

The problem is an enormous one. The FDA admits that about two-thirds of women who deliver have taken at least one prescription drug during their pregnancy, reports Reuters.

Here’s how it will work. Eleven health-plan affiliated research sites that have collected healthcare information for one million births over a seven-year period (2001-2007) will submit their data.

Included in the study are researchers at the HMO Research Network Center for Education and Research in Therapeutics, Kaiser Permanente’s multiple research centers, and Vanderbilt University, among others.

The lead researchers have already collaborated on the effects of anti-depressants, antibiotics, and cardiovascular medications on birth defects and outcomes.

“This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs in a statement. "These data will guide regulatory policy and influence medical practice."

Pregnancy and Drugs

Drugs cross the placenta during pregnancy and there is little information about most drugs taken during pregnancy. Most teratogens (an agent that causes birth defect) cause birth defects during the fifth to tenth week of embryonic development when the major organs are forming.

The most high profile example is thalidomide, given to women in the 1950s for nausea, which caused limb defects. Tetracyclines produce their effects after the first trimester when the skeletal system is forming. Other drugs such as ethanol may product harmful effect throughout pregnancy, reports OB Focus.

Pregnant women taking the drug valproate to treat epilepsy, may significantly increase their baby’s risk of developing autism, according to a new study published in the journal Neurology.

Statistically speaking, those children exposed to valproate sodium were seven times more likely to develop autism later in life compared to the children not exposed to the drug.

However, experts say the benefits of the drug and the high risk of seizures during pregnancy may outweigh the risk of autism.

WebMD reports on drugs safe to take during pregnancy. Included are Benadryl, Fiberall, Gaviscon, Metamucil, Monistat, Tylenol, among others. #

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