FDA Warning Over Contaminated Ingredients Leads to Paxil Antidepressant Recall

Paxil Recall

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FDA Warning Over Contaminated Ingredients Leads to Paxil Antidepressant Recall

GSK failed to warn customers that some batches of its Paxil antidepressant were contaminated by pharmaceutical waste prior to distribution.

Paxil maker GlaxoSmithKline is recalling some lots of its blockbuster antidepressant drug, which may, according to federal drug regulators, contain ingredients contaminated by industrial solvents. The Paxil recall was issued last week by the drug maker, following a warning by the U.S. Food and Drug Administration (FDA) accusing the company of distributing potentially contaminated batches of paroxetine, the active ingredient in Paxil. If you believe you or a loved one has been adversely affected by side effects of Paxil or another potentially dangerous medication, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a skilled product liability lawyer today. With a qualified Paxil attorney on your side, you can protect your legal rights and pursue financial compensation for your injuries and medical bills.

Paxil Pills Contaminated by Pharmaceutical Waste

Paxil is a popular antidepressant drug that falls into the category of selective serotonin reuptake inhibitors (SSRIs), which are commonly prescribed to treat depression. According to FDA officials who inspected GlaxoSmithKline’s Cork, Ireland plant in October 2013, some Paxil ingredients were contaminated by material from a pharmaceutical waste tank, and the company went ahead and shipped the medications to customers anyway without notifying them of the problem. GlaxoSmithKline responded to the FDA report, noting that the drug maker found it impossible to extract the contaminants from the Paxil ingredients and decided to ship the drugs after concluding that the contaminants did not impact the overall quality of the medication.

GSK Failed to Inform Customers of Contamination

Since its investigation at the Ireland facility, the FDA has called on GSK to explain how it reached this conclusion, how the company plans to fix quality control problems at the plant, and how it plans to deal with the contaminated Paxil pills that have 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 FDA warning 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 Paxil recall was initiated by GlaxoSmithKline shortly after this FDA letter became available to the public.

Contact an Experienced Paxil Lawyer for Help

This isn’t the first time the FDA has voiced concerns about the safety of GSK’s Paxil antidepressant drug. In December 2005, the agency issued an alert to consumers and the medical community about the risk of birth defects linked to Paxil use in pregnancy, after studies showed the SSRI could increase the risk of heart malformations in babies. GSK has since faced hundreds of Paxil lawsuits filed in courts throughout the country, on behalf of children who were born with birth defects and malformations after being exposed to the antidepressant in pregnancy. If you took Paxil while pregnant, and your child was born with a heart defect, persistent pulmonary hypertension of the newborn (PPHN), or another devastating birth defect, contact a Paxil lawyer today to discuss the possibility of filing a birth defect lawsuit against GlaxoSmithKline.

[box type=”note” align=”aligncenter” ]Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390435.htm[/box]

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