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drug_recall paxilPrescription drugs have the ability to save lives and make daily living more enjoyable. While there is no doubt there are significant benefits prescription drugs provide people all around the world, a dangerous trend appears to be emerging with millions of people taking drugs even though the risks associated to them may be greater than the benefits. Every year, millions of drug complications occur and in the past several years, major drug recalls have been announced because potentially deadly and very serious health effects were discovered years after approval.
The FDA has been under heavy scrutiny and growing criticism for its inability to adequately protect patients from potentially harmful drugs, according to many critics. Evidence that Paxil and other antidepressant drugs could cause suicidal thoughts in children and increase risk of Paxil deaths is just one of the many drug regulating problems that has been directed to the FDA.
An FDA whistleblower testified after an arthritis painkiller was withdrawn from the market September 30, 2004 that the FDA was not protecting Americans saying, “the system itself is completely broken.” Prior to the Vioxx recall problems, the FDA was also being accused of suppressing safety and efficacy data on antidepressants like Paxil among children and adolescents.
Parents whose children had begun taking Paxil and killed themselves began to wonder if the drug was responsible, which prompted the FDA to finally re-examine clinical data on antidepressants and children during 2004. The FDA found that the Paxil deaths, as well as other antidepressant drugs, were nearly twice as likely to have stemmed from suicidal tendencies than depressed children taking placebos.
The drug agency issued a Public Health Advisory on October 15, 2004, aimed mainly at heath care providers to warn of the increased risk of suicidal thoughts and behavior in children and adolescents treated with Paxil and other antidepressants. Health care providers were cautioned to closely observe pediatric patients for any signs of worsening. Suicidality has the potential risk of leading to Paxil deaths if not closely monitored.
All antidepressants now carry black box warnings, the government''s strongest warning short of banning a drug, and expanded warning statements that alert health care providers of the increased risk of suicidality. Warning labels now describe the increased risk of suicidal thoughts and behavior in children and adolescents on antidepressant medications, noting what the particular drug has been approved or not approved to treat. Currently, Prozac is the only medication approved to treat depression in children and adolescents.
While some FDA defenders say the new Paxil, and other antidepressants, warnings shows the FDA is in fact doing its job, others think it is a delayed action in response to heavy criticism and a loss of public confidence. New York Attorney General Eliot Spitzer accused GlaxoSmithKline, Paxil''s maker, of withholding negative information about Paxil, which settled, and families have filed lawsuits against the company for the risk of Paxil deaths that were unknown because of the suppressed information. The FDA is also requiring patient medication guides be given to patients by pharmacists that lists the risks and precautions of the drugs.
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...