Pharmalot
By Ed Silverman
June 30, 2010
There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.
“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…
Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.
A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”
1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.
2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.
3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.
4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.
5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.
6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.
7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.
Read entire article: http://www.pharmalot.com/2010/06/sara-carlin-paxil-and-drug-safety-in-canada/
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In an effort to get its arms around massive litigation, GlaxoSmithKline has agreed to settle yet another wad of product-liability lawsuits involving one of its popular meds. The latest deal involves an agreement to pay more than $1 billion to settle some 800 cases alleging its Paxil antidepressant caused birth defects in children borne to women who took the drug, Bloomberg News writes.
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