BOISE, Idaho, September 30, 2005

Study shows Paxil increases the risk of birth defects

The FDA has issued a warning for Paxil (paroxetine) and Paxil CR, antidepressants that may increase the risk of birth defects if taken by pregnant women during the first 12 weeks of pregnancy (first trimester). GlaxoSmithKline, the maker of Paxil and Paxil CR, has changed the drugs' labels to include the increased risk. 

The warning comes after a study showing babies with birth defects were born to women who were taking antidepressants during the first 12 weeks of pregnancy. Women who were taking Paxil or Paxil CR were more likely to have a baby with a birth defect than women who were taking other antidepressants. 

The study of 3,581 pregnant women found that 4 in 100 babies born to women who took Paxil or Paxil CR during the first 12 weeks of pregnancy had birth defects. In women who took other antidepressants, 2 in 100 babies were born with birth defects. This means that 96 in 100 babies born to women who took Paxil or Paxil CR during the first 12 weeks of pregnancy did NOT have birth defects. The risk of birth defects in the general population is 3 in 100. 

Women in their first 12 weeks of pregnancy who take Paxil or Paxil CR should talk to their doctors about other options. They should not stop taking Paxil or Paxil CR without first talking to their doctors.

More information is available from the FDA at 1-888-463-6332 or on the Web site at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2

ALSO. . .

FDA issues warning about ADHD drug Strattera and suicidal thinking in children and adolescents

The FDA has issued a public health alert about the increased risk of suicidal thinking in children and teens being treated with Strattera. Strattera is currently approved in the United States to treat attention deficit hyperactivity disorder (ADHD) in children, teens, and adults. 

The alert was based on studies of 2,200 children. One child who was taking Strattera tried to kill himself. Other studies showed that 4 in 1,000 children treated with Strattera thought about killing themselves. This means that 996 out of 1,000 children did not think about suicide. 

Health care professionals and caregivers are advised to watch for any behavior changes in children and teens taking Strattera. Parents and patients should discuss any changes in behavior with the child's doctor. These include increased agitation, irritability, or suicidal thinking. This is especially important at the beginning of treatment or when doses are changed. 

In addition, the FDA has asked the maker of Strattera, Eli Lilly and Company, to add a boxed warning to its label and to develop a medication guide that includes this new risk information. Pharmacists will give the medication guide to patients, families, and caregivers with each prescription or refill of Strattera. 

The FDA does not advise people to stop taking Strattera but only to watch for signs of suicidal thinking. More information is available from the FDA at 1-888-463-6332 or on the Web site at
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html

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