Tainted Paxil Recalled

Tainted Paxil Recalled

Oct 16

It appears that inherent dangers are not the only thing that plagues GlaxoSmithKline (GSK) with its antidepressant product Plaxil, also known as paroxetine which part of the selective serotonin reuptake inhibitor (SSRI) class of drugs. With $1 Billion already set aside to settle thousands of lawsuits regarding the alleged misrepresentation by the drug maker about the efficacy and safety of the drug, GSK is now footing the bill for a massive recall of several batches of Paxil made in their Cork, Ireland manufacturing plant.

The Food and Drug Administration (FDA) informed GSK in a letter that as per their October 2013 inspection of the facilities in Ireland, there problems in the process – so-called manufacturing deviations — which could potentially contaminate certain batches of paroxetine, the active ingredient in Paxil, from the manufacturing waste tank. GSK was forced to issue a Class 3 (from wholesalers) recall or risk getting disapprove for new or supplemental applications as an active pharmaceutical ingredient (API) manufacturer by the FDA. The warning letter gave GSK until April 9, 2014 to respond. The Paxil recall was issued bare weeks after GSK had issued a recall of another of its products, weight-loss drug Orlistat (tetrahydrolipstatin) for suspected tampering issues.

Product liability is basically divided into two major issues: defective design or defective manufacturing. In the former category, the product is deemed to be inherently harmful because of its design or components even if it is properly manufactured and used. In the latter, the process is flawed in some way, bestowing harmful characteristics to an otherwise safe product. In the case of Paxil, GSK has sustained losses due to both categories.

GSK claims that while it is issuing the recall pursuant to the terms of the FDA warning letter, the product included in the recalled batches does not pose any increased threat of harm to patients. This is based on their medical assessment of samples of the finished product from these batches. Even if this claim turns out to be accurate, GSK has a duty to ensure that their products are safe in both design and manufacture. Any injury that results from either makes the drug maker liable in civil court.