Now they tell us.
UPDATE 2-FDA--Early results suggest Paxil birth defect risk
Thu Dec 8, 2005 2:38 PM ET
By Lisa Richwine
WASHINGTON, Dec 8 (Reuters) - Pregnant women generally should avoid GlaxoSmithKline Plc's <GSK.N> <GSK.L> antidepressant Paxil, U.S. officials warned on Thursday after early findings from a second study suggested the drug may raise the risk of birth defects.
Paxil and generic versions sold as paroxetine "should usually not be taken during pregnancy," the Food and Drug Administration said.
The drug's benefits in relieving depression or other psychiatric problems may outweigh risks to a fetus in some women already taking the drug, or if no alternatives are appropriate, the FDA added.
Preliminary results from two studies found women who took Paxil early in pregnancy had a one-in-50 chance of having a baby with a heart defect, London-based GlaxoSmithKline said. The usual rate in the general population is one in 100.
Heart problems were the most common abnormalities recorded. Most cases were holes in the walls of the heart's chambers. Some required surgical repair, while others were mild enough to resolve without treatment.
"It is not clear if the findings from these studies represent a true causal association" between Paxil and birth defects, GlaxoSmithKline said in a letter to physicians.
Still, Glaxo said it felt it was important to alert doctors to the information. Details from the first study were announced in September and added to Paxil's prescribing information. Data from the second study are being added now.
In the first study of U.S. health insurer data on nearly 6,000 infants, the risk of heart defects was about 2 percent in babies whose mothers had taken paroxetine early in pregnancy, compared with 1 percent in the general population.
The second study was an evaluation of information from about 6,900 Swedish infants. Researchers found heart defects among 1.5 percent of babies whose mothers took paroxetine during their first trimester, compared with 1 percent if mothers took other antidepressants.
GlaxoSmithKline spokeswoman Gaile Renegar noted the studies were evaluations of databases and not clinical trials, which are considered the best way to evaluate risks and benefits.
Both the FDA and Glaxo said they were awaiting final results to better understand the birth-defect risk.
Women currently taking Paxil should not discontinue treatment without talking with a doctor first, the FDA said.
About 25 percent of U.S. prescriptions for paroxetine are for women of child-bearing age, Glaxo's Renegar said.
Shares of GlaxoSmithKline closed nearly flat in London trading. The company's shares were up 0.8 percent at $50.59 in afternoon trading on the New York Stock Exchange. (Additional reporting by Susan Heavey)