Drug Warnings: Paxil Side Effects and Risks

Paxil (generic paroxetine hydrochloride) is an antidepressant manufactured by the pharmaceutical giant GlaxoSmithKline. Paxil is approved by the FDA (Food and Drug Administration) to treat depression, anxiety, panic, obsessive-compulsive activity, and post traumatic stress in adults. It’s not approved for the treatment of children under 18, because studies have failed to prove Paxil is an effective treatment for children. Paxil is known as a SSRI (selective serotonin reuptake inhibitor) drug.

Paxil has been the focus of debates about safety and the target of several official warnings.

The FDA issued a December 2005 warning about the risks of birth defects in infants born to women who took Paxil during the first trimester of pregnancy. Paxil increased “the risk of congenital malformations, particularly cardiovascular malformations.” Paxil has been more likely to cause birth defects than other SSRIs.

In March 2006, Health Canada issued a strongly worded warning to all pregnant women to take great care in using SSRIs during pregnancy because of the risk of danger to their babies that could be life threatening. Pregnant women were advised to discuss the dangers with their health care providers.

Studies have linked Paxil in particular to cardiovascular malformations, and one study has linked all SSRIs, including Paxil, with three other malformations, two of the head and one of the abdominal wall.

A 2006 study linked SSRIs with a sometimes fatal lung condition in infants whose mothers had taken the drugs.

In March 2006, an FDA research team reviewed studies on children and suicide and concluded that SSRI use increases risks for suicidal thoughts and behavior in patients under 18. An earlier FDA Public Health Advisory warning was given in October 2003, to inform the public about possible increases in suicide and violence in children and teenagers using Paxil. A few months earlier, in June, the British drug regulatory agency had ruled that Paxil should not be prescribed for children. The FDA has not banned the use of SSRIs for children under 18, in spite of a lack of evidence that the treatment with drugs like Paxil is effective for patients in that age group. The FDA has chosen to rely on increased warnings.

Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney: