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drug_recall paxilAccording to FDA data, at least 110 American kids have killed themselves while taking antidepressants during the past decade. Controversial antidepressant drug Paxil and suicide links and risks have been making headlines as mounting pressure from critics and Congress has been put on the FDA to publicly disclose reports associating antidepressant medications to increased risk of suicide among children. The FDA withheld an internal finding showing Paxil and suicide occurs twice as often as kids on sugar pills, as well as other antidepressant medications, at the start of 2004.
British authorities, on the other hand, chose to immediately act on this information, issuing warnings to physicians not to prescribe Paxil, Zoloft, Celexa and other similar drugs to children. An FDA scientist Andrew Mosholder found children getting antidepressants had a higher risk of "serious suicide related events" in February 2004, but the agency forbid Mosholder to present his findings in a February hearing or to discuss them, claiming his Paxil and suicide link was premature. Mosholder told Senate investigators that he was pressured to change his recommendation but refused to do so.
According to a memo dated February 18, 2004, Mosholder warned the agency that a new analysis would waste time, and he urged the agency to take interim steps of officially discouraging the use of antidepressant drugs for children. Agency officials have said they do not plan on discussing the data until a scheduled September meeting, and instead called for stronger warning labels to remind doctors to be vigilant about Paxil and suicide. So controversial is the Paxil and suicide link that multiple congressional investigations are underway looking at the safety of antidepressant drugs.
In June 2004, New York Attorney General Eliot Spitzer filed suit against antidepressant maker GlaxoSmithKline, accusing them of fraud for withholding reports of Paxil and suicide or violence among children. Although most the documents remain only under Glaxo''s possession or under seal in lawsuits, the company has posted some previously unpublished studies following Spitzer''s suit on its Website. A group of Columbia University doctors have been asked by the FDA to review reports to determine if antidepressant drugs, including Paxil and suicide among children is twice the risk when compared to sugar pills.
Many regulators are concerned by the delay in the FDA''s response to concerns of Paxil and suicide risk among children, as well as other popular antidepressants, and the chairman of the Senate Finance Committee released a statement in early August 2004 that "it''s been almost nine months since British regulators issued new recommendations, and it''s been six months Dr. Mosholder made his determinations. Now, given this new information, it''s fair to ask if the Food and Drug Administration is taking too much time to draw a conclusion." Even experts initially believing British regulators went too far in immediately acting on Paxil and suicide risks have felt any evidence indicating otherwise has failed to reveal itself, yet FDA action has still not been issued.
As doctors continue to prescribe Paxil and other antidepressant drugs to millions of kids, the FDA is still considering whether stronger warnings or advisories against their use will be released, as British regulators have already done. The controversy surrounding possible Paxil and suicide links is still continuing despite being over a year after the first concerns emerged.
Use of the anti-depressant drug Paxil during pregnancy has been linked to a very serious birth defect in infants - PPHN<...
The manufacturer of the popular antidepressant Paxil is facing yet another lawsuit filed by a South Carolina couple who claim the drug directly caused their daughter to suffer a birth defect.
Product Liability Lawsuit
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Pharmaceutical giant GlaxoSmithKline PLC is facing two new lawsuits that allege their popular antidepressant drug, Paxil, causes serious birth defects including heart abnormalities and deaths when used during pregnancy.
According to the lawsui...