Are Paxil Birth Defects Linked to Problems at Former Plant?

Cidra, Puerto RicoPaxil side effects that may have worsened, for some, as the result of GMP (good manufacturing practices) problems at a foreign plant once operated by Paxil manufacturer GlaxoSmithKline (GSK) only adds to the standard basket of risks inherent with any drug. To that end, it is a given that all drugs will carry some kind of adverse reaction—in Paxil's case, the potential for Paxil birth defects. However, a drug falling victim to manufacturing problems only exacerbates that risk.

To that point, the CBS investigative news juggernaut "'60 Minutes" recently showcased the problems surrounding a former GSK plant located at Cidra, Puerto Rico. The plant is now closed, and the Paxil manufacturer agreed to the payment of $750 million in fines and penalties to resolve a whistleblower lawsuit brought against it.

The CBS report followed the story of Cheryl Eckhard and her efforts to try and persuade her employer at the time—GSK—to respond to evidence of poor manufacturing practices at the plant. It was Eckhard's fear that GMP failures at the plant could serve to harm patients taking drugs manufactured there—a point that appeared to be substantiated by way of an eight-year-old boy who may have taken Paxil at 25 milligrams, rather than the 10 milligrams originally prescribed, due to mislabeling and problems at the plant.

However, GSK is reported to have taken issue with the "60 Minutes" report that aired on the second day of the New Year. The Raleigh News & Observer reported on January 4 that in spite of the facts, observations and allegations reported on the iconic investigative journalism platform "GSK strongly disagrees with '60 Minutes' implication that patients suffered harm as a result of the [plant] issues," the company said, in a statement issued January 3, a day after the story aired on CBS.

The newsmagazine "misrepresented the situation," spokeswoman Mary Anne Rhyne said in a statement. "We felt there was additional information the public needed to know." The issues outlined in the report occurred between 2001 and 2005 and were related to one manufacturing facility, GSK said. "GSK regrets the manufacturing issues at the [Puerto Rico] facility, which were inconsistent with GSK's commitment to manufacturing quality."

Eckhard, who worked for GSK as a quality-assurance manager, was sent to evaluate the Cidra plant (at which Paxil was manufactured) in 2002, several months after GSK received a warning letter from the US Food and Drug Administration (FDA) over manufacturing processes at the plant.

Eckhard reportedly saw enough of a problem to recommend the plant be shut down and trucks laden with freshly manufactured drugs not be allowed to leave the facility. Eckhard reported problems with sterility, manufacturing problems that allegedly resulted in drugs getting mixed up with other drugs, and drugs of varying strengths showing up in mislabeled bottles.

Paxil, which has been linked to various Paxil defects, was among the drugs cited as being affected by the situation. Eckhard alleges she went to her superiors on at least two occasions, only to be ignored and then laid off in an apparent downsizing. She sued, and will earn a share in the federal government recovery according to provisions of the False Claims Act.

CBS reported Eckhard's claim that water used to make tablets was tainted with bacteria. "There were also alleged failures on production lines that made some drugs too strong, some not strong enough; and the employees were contaminating products," the show reported.

"All the systems were broken, the facility was broken, the equipment was broken, the processes were broken," she said on the show. "It was the worst thing I had run across in my career."

For its part, GSK said it strived to "bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA."

Meanwhile, many a Paxil lawsuit has alleged Paxil heart defects and other birth injuries as a result of the mother taking Paxil while pregnant. Unrelated to Paxil side effects, GSK announced January 17 that it was setting aside $3.4 billion to fund its liability extending from a US government investigation and various product liability cases over its marketing of Avandia, the The New York Times reported today.