Paxil Recall Issued Following FDA Warning Over Contaminated Ingredients

GlaxoSmithKline is recalling some lots of the antidepressant Paxil, which may contain ingredients that are contaminated by industrial solvents.  

The Paxil recall was announced this week by GlaxoSmithKline, after the FDA sent a warning letter to the drug maker accusing it of distributing medications with potentially tainted batched of paroxetine, the active ingredient. None of the potentially contaminated pills appear to have been shipped to the U.S., however. The recall affects batches sold only in Ireland.

The warning letter, sent late last month, noted that FDA officials inspected the company’s Cork, Ireland plant in October 2013. They found deviations from current good manufacturing practices at the plant.

Inspectors said that the company discovered that material from a pharmaceutical waste tank contaminated some Paxil ingredients and the company went ahead and shipped the drugs anyway. While the report redacts the names of all the ingredients involved, GlaxoSmithKline officials acknowledged in emails sent to media outlets that the chemical at the center of the issue was paroxetine.

The report notes that the company found that it appeared to be impossible to extract the contaminants from Paxil ingredients, but concluded that there was no quality impact and shipped the pills anyway.

The FDA called on GlaxoSmithKline to explain how it reached its conclusions, how it planned to rectify quality control problems at the plant and how it planned to deal with Paxil that had already been distributed.

“We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact,” the letter states. “In your response…you acknowledged that you should have informed your customers of this incident, however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse.”

The recall was announced shortly after the letter became available to the public.

Paxil Birth Defects

Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, generating sales of about $1 billion a year.

In December 2005, the FDA issued an alert in the United States about the risk of birth defects from Paxil, after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label in this country to include information about the pregnancy risks with Paxil.

The company has faced hundreds of Paxil lawsuits in the United States, which were brought on behalf of children who suffered various birth defects and malformations, such as persistent pulmonary hypertension in newborns (PPHN) and other health problems. The complaints alleged that Glaxo purposefully hid test results that would have revealed the risks associated with use of Paxil during pregnancy and misled doctors.

In 2010, it was reported that GlaxoSmithKline set aside $2.4 billion to settle Paxil birth defect lawsuits.