Pennsylvania Women File Lipitor Type 2 Diabetes Lawsuits
Paxil manufacturer GlaxoSmithKline is coming under fire after the US Food and Drug Administration (FDA) sent a warning letter to it about unacceptable manufacturing and communication procedures at a Cork, Ireland plant.
According to the release, the agency found contamination issues at the site and said that the manufacturer’s response “lacks sufficient corrective actions.” The plant reportedly makes active ingredients for the anti-depressant Paxil and has since recalled batches of the drug.
The FDA letter said that failure by the pharmacy to address issues at the plant could lead to the company banning materials produced at the site.
“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 agency wrote.
Injured by Paxil?
Contaminated drugs have been linked to personal injuries and death; keep in mind the outbreak of fungal meningitis cases in 2012 following the New England Compounding Center (NECC) steroid spinal injection recall.
Additionally, Paxil and other SSRI antidepressants have been linked to birth and development defects in children with the use of SSRIs during pregnancy. For more information about antidepressants and birth defects, talk with our SSRI lawyers by calling 888-841-9623 for a free initial review of your case.
Zoll & Kranz, LLC – SSRI attorneys
ZKB’s ‘Did You Know?’: SSRIs have been linked to cleft lip and palate among newborns.