FDA: Paxil May Put Newborns at Risk for Birth Defects

A study conducted in 2005 by drug giant, GlaxoSmithKlinePLC (GSK), was recently reviewed by the FDA, who now warns the medication could cause a range of birth defects. According to WebMD, data was collected from over 3,500 women taking Paxil during the first 3 months of pregnancy. The medication has not been totally banned for pregnant women, though the warning was upped from Class C to Class D, meaning there is evidence the drug poses a known risk to unborn children. Although it is not recommended expectant mothers take this medication, doctors may continue to prescribe it if the benefits for the mother outweigh the risk posed to the fetus. The FDA made the following announcement:

“FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.”

Paxil is an anti-depressant, and part of the SSRI (selective serotonin reuptake inhibitors) family of drugs, which also include Zoloft and Prozac. GSK issued a statement on the Paxil website, advising patients to "Tell your doctor if you are pregnant or plan to become pregnant as there is a potential risk to the fetus with [Paxil]. Some studies of [Paxil] in pregnant women have suggested a possible increased risk of malformations, while others have not shown such a risk."

According to GSK’s research, women taking Paxil during the first trimester of pregnancy were almost twice as likely to have a baby with atrial or ventricular defects. The specific defect is known as a septal malformation, where holes form between the 2 chambers of the heart. In many cases, the defect can repair itself, although some instances require surgery.

MedicineNet reports that women taking Paxil and other SSRIs during the third trimester have documented other problems as well. The most noted are withdrawal symptoms exhibited by newborns. Doctors advise against stopping Paxil suddenly because withdrawal can pass from the mother onto the child. GSK also issued the following statement concerning the third trimester risks on the Paxil website:

"Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.”

A 2010 Reuters article mentioned that GSK settled over 800 Paxil related birth defect claims, which amounted to more than $1 billion. Anyone who might be pregnant and currently taking this medication is encouraged to discuss these risks with their doctor or health care provider.

References:

Hitti, Miranda. (September 27, 2005) “Paxil's Birth Defects Warning Strengthened.” Retrieved on May 24, 2011, from WebMD.

Lee, Dennis, MD. (January 4, 2006) “Paxil, Pregnancy, and Birth Defects.” Retrieved on May 24, 2011, from MedicineNet.

Hirschler, Ben. (July 20, 2010) “Glaxo Says Settles Some Paxil Birth-Defect Cases.”  Retrieved on May 24, 2011, from Reuters.