GlaxoSmithKline (GSK)

So far, GSK has paid more than $1 billion to settle patent lawsuits alleging Paxil caused birth defects in some women who used the drug during pregnancy. The settlements averaged about $1 million per claim. GSK continues to settle lawsuits on birth defects claims.

The legal woes led the Food and Drug Administration (FDA) to order GSK to change Paxil’s label to indicate a risk for birth defects when used during pregnancy. Newer studies are beginning to suggest that other antidepressants in the same class – known as selective serotonin reuptake inhibitors, or SSRIs – may be just as dangerous to developing fetuses as Paxil. Other drugs in this class include Zoloft, Celexa, Lexapro and Prozac.

GSK’s multi-billion dollar fund not only is designed to resolve issues with Paxil, but also with its type 2 diabetes drug Avandia. The FDA recently severely restricted use of the drug after studies showed Avandia puts users at risk for fatal heart attacks.

The FDA recently warned about another type 2 diabetes drug, Actos, manufactured by Takeda, after studies showed that drug may put users at risk for bladder cancer.

Source: Business Week

SOURCE: Paxil and Pregnancy › GSK socks away billions to cover legal costs with Paxil, Avandia