April 3, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to GlaxoSmithKline (GSK) after finding that the company did not fully address contamination in certain lots of Paxil (paroxetine). GSK has agreed to recall the affected batches.
The problem was discovered during an investigation of a facility in Cork, Ireland. The FDA alleges that GSK became aware that pharmaceutical waste (active ingredients, intermediates, and solvents) could potentially contaminate Paxil in January 2012. It took until April 2013 to complete a risk-assessment. In the meantime, GSK continued to sell potentially-contaminated Paxil.
GSK has defended themselves by saying that the problem is not likely to cause patient injuries. However, the FDA says it is “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 FDA has threatened to embargo shipments of drugs from Cork, Ireland. They have also threatened to withhold approval of any new drugs manufactured by GSK. If the FDA was forced to take such actions, it could interrupt supply — the facility is the main site where paroxetine is manufactured, according to Reuters.