June 9, 2015
By Alex Keown, Riley McDermid and Mark Terry, BioSpace.com Breaking News Staff
NEW YORK – A report from Pfizer Inc. shows a scientist urged company officials change safety labels for the popular antidepressant Zoloft after a potential link between the drug and birth defects was shown, Bloomberg reported this morning.
Last week during a trial in Pennsylvania where the plaintiff alleges Zoloft prescribe to her during her pregnancy was a direct cause of her child’s heart abnormalities, a 2014 internal report issued by Francesca Kolitsopoulous, who was associate director in Pfizer’s Worldwide Safety Strategy unit’s epidemiology group, said a review of published studies showed an association between the medicine and “cardiac malformations, which could be causal.”
Bloomberg noted the 2014 review “concluded researchers found links between Zoloft and septal heart defects, a congenital disorder that features a hole in a baby’s heart.” Additionally the report showed researchers found links between Zoloft and omphalocele, a birth defect of the abdominal wall where intestines or organs form outside the belly. According to the report, Kolitsopoulous proposed a modification of the drug’s warning label to note the findings of the research.
“While the risks may appear to be increased for specific birth defects, these defects are rare and the absolute risks small,” Bloomberg reported her as saying in the report.
The trial also showed a Pfizer review of 50 safety reports from 1988 that documented side effects of Zoloft taken by 50 pregnant women. The report, which was made public for the first time during the trial, found 25 cases involving “congenital abnormalities” or other “adverse events” that were “possibly related” to Zoloft use, Bloomberg said.
Pfizer has maintained there is no direct link between the drug and birth defects, but the report could add fuel to the lawsuits filed by parents who have children born with malformed hearts. Pfizer is facing more than 1,000 lawsuits from plaintiffs saying the company continued to market Zoloft, even though there were alleged links to cardiac issues in newborn children.
In November 2014 the company asked a Pennsylvania judge to dismiss more than 500 of them. Those suits, of which there were 526, were combined into a multidistrict litigation, which is similar to a class action suit but the plaintiffs have their cases settled individually. Of those 526 cases, 443 were from Pennsylvania.
In a statement, Pfizer indicates that reports to the U.S. Food and Drug Administration (FDA) and the European regulators confirm the drug’s safety data and Pfizer hadn’t identified a “signal for congenital anomalies and that a comprehensive review of the literature did not support an association between use of Zoloft and birth defects, including cardiac anomalies. … Plaintiffs have taken a single statement in one document, summarized the results of a few studies, out of context.”
Pfizer already successfully defended one lawsuit in April, but that was before the report was brought to light in the Pennsylvania case.
At that time, Pfizer won the first round of a lawsuit taking place in St. Louis that claimed Zoloft caused birth defects in a boy from California. That court found that Pfizer was not liable and will not have to pay compensatory or punitive damages.
The case had been brought by Joseph Zonies of Colorado law firm Reilly Pozner on behalf of Kristyn Pesante, and had claimed Pfizer did not warn doctors about the potential risks of birth defects while taking Zoloft. Pfizer’s victory Friday is significant because Pesante’s claim was selected as a test case for other claims, which some trial lawyers had hoped could reach class action status.
There was no news Tuesday on whether Zonies might appeal based on the new evidence.
In 2005, the last year of Zoloft’s patent protection against generics, the drug earned more than $3.3 billion for Pfizer, which made it the best selling antidepressant on the market. Generic versions hit the market in 2006. Most generic versions are currently manufactured by Roxanne Laboratories, Bidnessetc reported.
Another popular antidepressant, Paxil, manufactured by GlaxoSmithKline , was the subject of a similar lawsuit linking that drug to birth defects in children born from women who were prescribed the medication.
In April Pfizer settled a class action lawsuit regarding its Parkinson’s drug Cabaser.
Patients in Australia filed a lawsuit claiming they did not have adequate warning about potential side effects of the drug, including gambling and sex addiction and other high-risk activities.
The 160 patients who took the drug were being treated for tremors associated with Parkinson’s or restless legs syndrome between 1996 and 2010. The patients indicated they had gambled and lost hundreds of thousands of dollars after taking Cabaser.
When Will Pfizer’s Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016,” said Chris Schott, an analyst at J.P. Morgan. “Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile.”
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?
