Pfizer ($PFE) executives were warned by one of their own scientists about a potential link between the antidepressant med Zoloft and birth defects, accordingly to a newly surfaced document cited by Bloomberg.
The Pfizer drug safety official last year recommended changes to Zoloft's label warnings, while the company publicly maintained that Zoloft was not proven to cause congenital heart problems, the news service reports. The drugmaker is fighting more than 1,000 lawsuits alleging that Zoloft triggered heart abnormalities in infants born to women who used the drug while pregnant.
The lawsuits claim that Pfizer knew Zoloft could cause heart defects. The company prevailed in the first such lawsuit to go to trial. In April, a St. Louis jury nixed claims that Zoloft caused heart defects that required extensive surgeries to fix.
In addition to the drug-safety scientist's recommendation to executives, lawyers in the latest case put forth a 1998 report showing that company researchers found more than a dozen side-effect reports about birth defects, and concluded that Zoloft couldn't be ruled out as a cause, Bloomberg notes.
Pfizer told the news service that the lawyers are misusing the internal documents, cherry-picking data from the company's review of adverse event reports. The plaintiffs also "ignored the conclusions of these reports that contradict their testimony," spokeswoman Christine Regan Lindenboom told Bloomberg.
Plus, recent regulatory filings offer more evidence that no credible link has been found between the drug and birth defects, Lindenboom said. The company has previously said that it has consistently updated the FDA about any safety issues associated with Zoloft, and that the drug's label already cautions against its use during pregnancy.
In 2010, GlaxoSmithKline ($GSK) paid more than $1 billion to settle hundreds of lawsuits alleging its antidepressant drug Paxil increased the risk of birth defects. Paxil and Zoloft are two drugs in the class of depression-fighters known as selective serotonin reuptake inhibitors, or SSRIs.
- read the Bloomberg story