Whistleblower Alleges Problems with Paxil Doses

Boston, MAWith some pregnant women concerned about Paxil side effects and what consequences potential Paxil birth defects could have on their infants, news that some Paxil shipments contained incorrect doses might be a cause for alarm. Although those shipments occurred in the past—they were recently discussed in a 60 Minutes news report—they could add to concern that drug companies are more interested in profit than patient safety. Some women are already concerned that Paxil side effects caused birth defects in their newborn babies.

The allegations about problems with Paxil shipments—and shipments of other drugs—came during a 60 Minutes interview conducted by Scott Pelley (01/02/11) with Cheryl Eckard, a former quality control manager at GlaxoSmithKline, whose concerns about the company's plant in Cidra, Puerto Rico, resulted in a massive investigation and fines against GlaxoSmithKline.

Eckard says her survey of the plant was the worst she had seen in her career. During her survey, Eckard reportedly saw tainted water used to produce tablets, drugs that were made with incorrect doses and contamination of products. Eckard also says she discovered mix-ups in packaging, including Avandia and Paxil medications being mixed together in the same packages. And, though she alerted GlaxoSmithKline officials about the problem, they reportedly did not stop the shipments that contained the mixed-up drugs.

Eckard further alleges that medications that were too strong were shipped out, including to an eight-year-old boy who might have received two-and-a-half times the Paxil dose he was meant to receive.

For its part, GlaxoSmithKline issued a statement that no one was injured because of errors at the Cidra plant and that it never lied to the FDA about procedures at the plant. The plant at Cidra has since been shut down, although GlaxoSmithKline says the move was for commercial reasons and not due to manufacturing problems.

Last year, GlaxoSmithKline paid $750 million to settle allegations about distributing adulterated drugs, including Paxil CR, and to settle Eckard's lawsuit. Also in 2010, GlaxoSmithKline paid approximately $1 billion to settle around 800 lawsuits alleging Paxil was linked to an increased risk of birth defects when women took the antidepressant while pregnant.