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The popular antidepressant Zoloft, as well as other well-known brand name antidepressants have been under attack and a source of nationwide debate. Concerns were first raised in 2003, with the controversy becoming more heated after the FDA decided to withhold two internal findings showing Zoloft might cause an increased risk of suicide among children until its scheduled September 2004 meeting. Already, British authorities have warned physicians not to prescribe Zoloft and similar drugs to children, and by the September 2004 FDA meeting it will have been nine months after the British warning and over a year after initial concerns were raised.
In August 2004, SSRI Citizen announced a national awareness campaign targeting antidepressant drugs Zoloft, Paxil, Prozac and Effexor. Part of a class of drugs called selective serotonin reuptake inhibitors (SSRIs), the consumer activist group wants to educate the general public about what they believe to be serious health risks associated to the use of the drugs. So far, the drugs have been named in thousands of lawsuits, alleging such effects as Zoloft addiction and Zoloft withdrawal.
For every Zoloft withdrawal report or Zoloft withdrawal lawsuit some experts believe there are many more instances that go unreported. A July 2004 Zoloft lawsuit, the most recent to be filed, alleged maker Pfizer misled physicians and the public regarding Zoloft''s safety and efficacy, in particular the suicidality and Zoloft withdrawal symptoms caused by the drug. Although the FDA has failed to publicly disclose either of the two internal reports linking use of Zoloft to increased risk of suicide among children, the FDA advisory committee urged more warnings be given to pregnant mothers using antidepressants like Zoloft in July 2004.
The mothers using the antidepressants may cause their newborn to suffer Zoloft withdrawal, and the Pediatric Advisory Subcommittee of the FDA has advised the agency require new warning language on SSRI and SNRI antidepressants to inform patients that these potential Zoloft withdrawals can occur. Zoloft withdrawal can have potentially significant effects on the baby, and despite any lack of conclusive evidence the effects present enough risk that many regulators think women should know about the possible harm. Doctors are usually the ones to receive drug safety related information in question, but an FDA subcommittee member and Mayo Clinic researcher believes the women should also be receiving information of possible Zoloft withdrawal effects as well.
Many consumers have criticized large pharmaceutical companies of withholding crucial information, and in the case of Zoloft withdrawal symptoms both adults and infants have exhibited signs that lead some experts to believe it is a significant problem. Reports show infants showing signs of agitation, irritability, trouble feeding and sleep disturbances, which regulators think might indicate Zoloft withdrawal symptoms. Adult patients complaining of Zoloft withdrawal said they did not realize it was a risk until trying to go off of the antidepressant and should have been warned.
A 15-year old boy, Chris Pittman, was convicted by a jury on two counts of murder in the 2001 killings of his paternal grandparents.
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