Paxil Lawsuits Set to Go Ahead

Grand Rapids, MIStudies have shown conflicting evidence of serious Paxil side effects, but that has not stopped approximately 600 Paxil lawsuits from alleging a link between the antidepressant and birth defects. Nor has it stopped at least one jury from awarding $2.5 million to a family of Lyam Kilker, who alleged in their lawsuit that his heart problems were linked his mother's use of Paxil while pregnant.

According to Bloomberg on 10/13/09, Kilker's was the first of approximately 600 cases to come to trial. The jury in the case found that GlaxoSmithKline failed to properly warn doctors and pregnant women about the risk of using Paxil while pregnant.

A GlaxoSmithKline spokesperson wrote in an e-mailed statement that the company will appeal the decision. "The scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition," the e-mail said.

The next case scheduled to be heard is that of the Novak family, who say their daughter was born with birth defects after her mother, Laura Novak, took Paxil while pregnant. What makes the case unique is that Paxil was not prescribed to Ms. Novak to treat depression. It was allegedly prescribed off-label to treat migraine headaches.

According to reports, Delaney Novak has undergone two open heart surgeries and two cardiac catheterization procedures since she was born. She will probably require more surgery as she grows.

While it is not illegal to prescribe a drug for off-label use, it is illegal to market it for such uses. The Novak family's lawyer says he can prove that GlaxoSmithKline encouraged off-label use of Paxil for the treatment of migraine headaches.

Regardless of what the Paxil studies have shown, the US Food and Drug Administration (FDA) has put Paxil in pregnancy category D, meaning that studies and/or adverse reaction data have indicated fetal risk, although the benefits of the drug may outweigh its risks. However, the FDA's pregnancy category is based on the drug's approved uses. In Paxil's case, that includes treatment of depression but not migraines.

Whether or not the benefits of taking the drug for migraine headaches outweighs the risks of not taking the medication—that is, whether migraines cause more damage to the mother and/or the fetus than the medication—has not been determined.