Paxil Birth Defects Trial Underway in Nation’s Birthplace

September 14th, 2009. By AbiK

It’s somehow eerily fitting that the bellwhether trial case for GlaxoSmithKline’s (GSK) Paxil is taking place in Philadelphia—the nation’s birthplace. You can’t really think of such a trial going on in Philly without recalling a few excerpts from the Declaration of Independence—and not just the more famous lines about unalienable rights but also some lesser quoted phrases like “Such has been the patient sufferance of these Colonies”; substitute the word “mothers” for “colonies” and you’ve just advanced 233 years to be talking about Paxil.

At the heart of the trial that’s now underway is GSK’s allegedly knowing—and failing to warn patients—that its anti-depressant drug, Paxil, could cause birth defects.

All eyes are on this first case which centers on Lyam Kilker, now 3, who has suffered life-threatening heart defects since birth. According to bloomberg.com (9/11/09), Michelle David, Lyam’s mother, was quoted as saying that:

…she was prescribed Paxil during her first trimester to treat mild anxiety. Lyam was born with defects including two holes in his heart as a result of taking the drug, she said in court papers. The infant underwent multiple surgeries within six months of his birth, she said.

She said wouldn’t have taken Paxil if she knew of the risk and contends that Glaxo failed to warn her or her doctors.

“All of Ms. David’s physicians who prescribed Paxil just prior to and during her pregnancy with Lyam have testified that had they been warned that Paxil could increase the risk of cardiovascular heart defects, they would not have prescribed it to her,” according to court papers.

Needless to say, GSK’s position is that there’s no mea culpa; however, reports estimate at least 600 additional cases waiting in the pipeline for the outcome of this trial to say just whose culpa it is. For the sake of legacy of our forefathers, let’s hope prudence prevails.

Tags: Glaxo, GSK, paxil, paxil-heart-defects-newborn

This was posted on Monday, September 14th, 2009 at 3:31 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.