Paxil Birth Defects

Washington, DCFollowing the recent news that GlaxoSmithKline may have purposely misrepresented information about the suicide risk for Paxil, patients who took the antidepressant are wondering what else the company may have kept hidden from regulators. Women who took Paxil while pregnant and delivered babies with birth defects are likely not surprised to learn about this latest development. Many of them are investigating lawsuits against GlaxoSmithKline, alleging the company did not fully warn patients about the risks to their babies.

As reported in The Wall Street Journal, a recently unsealed report, written by a Harvard psychiatry instructor, says that GlaxoSmithKline "improperly" counted patients who took placebos during clinical trials. Data given to the FDA showed that there was no major difference in the risk of suicidality between patients who took Paxil and those who took the placebo.

But the report argues that the actual risk of suicidality is eight times higher for patients who take Paxil than it is for patients who take a placebo. The report also says that GlaxoSmithKline knew about the increased risk associated with Paxil but did not accurately report it, choosing instead to report that placebos and Paxil had approximately the same risk of suicidality. Senator Charles Grassley has now asked the FDA to investigate reports that GlaxoSmithKline hid the actual risk of suicidality from the agency. He notes that the UK has recently concluded that the company withheld vital information when it applied form Paxil approval in Europe.

Women who took Paxil while pregnant and gave birth to babies with severe birth defects may not be surprised that the antidepressant could be more harmful than the public was led to believe. These women took Paxil believing the drug to have more benefits than risks, only to deliver babies with serious heart defects. They all argue that, had they known the true extent of the risks associated with Paxil they would never have taken the drug while pregnant.

Recent studies have shown that taking Paxil while in the first trimester of pregnancy doubles the risk of a baby with a congenital malformation. Paxil has also been shown to increase the risk of having a baby born with persistent pulmonary hypertension of the newborn (PPHN). In fact, the risk of having a baby born with PPHN increases by six times for women who take Paxil during the last trimester of pregnancy.

If you took Paxil during pregnancy and gave birth to a baby with serious birth defects, including PPHN and congenital heart malformations, contact a lawyer to discuss your legal options.