Children and Paxil
Paxil is an antidepressant drug that has been the target of criticism and lawsuits. According to latest figures, doctors are prescribing more antidepressants to children and adolescents despite the little evidence about their safety or efficacy.
Dr. Ian Wong, of the Centre for Paediatric Pharmacy Research at the University of London, and his team compared prescribing trends in Britain, France, Germany, Spain, Canada, the United States, Argentina, Brazil and Mexico using information from an international database containing a representative sample of medical practitioners in each country. While some people believe the increased use of antidepressant drugs is a reflection of an increased awareness and diagnoses of mental illnesses, safety warnings have been issued by drug agencies.
In the summer of 2003, British health regulators warned doctors that children and Paxil prescriptions should not be given to patients 18 years and younger. Britain's position on Paxil was what set off much of the public awareness and discussion about the use of antidepressant drugs in children.
In the United States, New York Attorney General Eliot Spitzer filed a lawsuit against the British based drug company GlaxoSmithKline, accusing it of concealing negative information pertaining to children and Paxil, which later reached a settlement. Spitzer alleged the company fraudulently suppressed information about Paxil's ineffective treatment methods in youngsters and evidence that it instead could increase the risks of suicidal behavior.
Children and Paxil users continue to increase, which is especially concerning to many critics considering doctors are still unsure of why antidepressants can lead to increased suicidal thought. The FDA was initially established to monitor short-term medicine effects, but with drug companies focusing more on profitable long-term medicines, the drug agency has been widely criticized for failing to adequately respond to shifting trends in the name of public safety.
The FDA issued a Public Health Advisory in October 2004, aimed mostly at heath care providers to warn of prescribing children and Paxil antidepressant drugs. The FDA directed all antidepressant drug manufactures, including Paxil's GlaxoSmithKline, that a black box warning must be added to its products, the government's strongest drug warning. In addition, expanded warning statements alerting health care providers of an increased risk of suicidality in children and adolescents must now be provided, as well as guides for patients to advise them of risks and precautions that can be taken while using Paxil and other antidepressants.
The announcement for increased safety measures with children and Paxil and other antidepressant drugs comes at a time when the FDA has been accused of lagging in ensuring public safety and is fighting to regain public confidence. The FDA warns doctors that any children and Paxil users should be closely observed for clinical worsening, as well as agitation, irritability, suicidality and unusual changes in behavior, especially when beginning drug therapy or at a time of dose changes.
Need Legal Help?
Contact us for free information or to start a free case review.