Is the FDA adopting a more proactive stance on drug safety issues? Following the withdrawal of Vioxx and the more recent furor over Avandia, the agency has been at the receiving end over drug safety concerns.
Avandia received a black box warning, which still says that the link to cardiovascular risks is not conclusive and advises consulting a doctor regarding continuing treatment with the drug. Sanofi’s Acomplia did not receive FDA approval as it was linked to an increased risk of suicide.
The latest drug to draw attention is the anti-smoking pill Chantix and the FDA is reviewing adverse event reports submitted by the manufacturer Pfizer about the drug. A preliminary assessment found cases where patients experienced "depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating treatment".
The agency said the role of Chantix was "not clear" in suicidal cases, because stopping smoking can exacerbate existing psychiatric symptoms, and create nicotine withdrawal symptoms. However, it said doctors should monitor patients taking Chantix for behavior or mood shifts, and patients should contact their doctors if they notice any changes
Chantix is the first drug of its kind to reduce the intensity of nicotine cravings while also making smoking less pleasant. The drug affects dopamine, a chemical in the brain involved in controlling mood and behavior. As dopamine triggers a positive mood response, regulating its levels can remove some of the pleasure derived from smoking.
The FDA is currently analyzing all material submitted by Pfizer and expects to communicate its conclusions and recommendations once its analysis is complete.
James Kelly, analyst at Goldman Sachs, said: "It will be key to watch physician behavior in the wake of this public disclosure, as well as the FDA's future communications, based on additional data and analysis provided by Pfizer."
- D R Sudhakar
Thursday, November 22, 2007
Drug Safety Surfaces Again
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5 comments:
Very recently, the withdrawal of Exubera from the market by Pfizer, made me wonder what is it that really makes a drug a success. Having had severe insulin dependent gestational diabetes during both my pregnancies, I was ecstatic to know that finally there was a drug in the market which did not require needle-phobic diabetics to go through the daily pain of taking multiple shots. My endocrinologist had warned me that my family history and my history of gestational diabetes made me a prime candidate for getting diabetes early on in life. Hence my utter joy at knowing that now there was an alternative to taking multiple daily shots in the form of inhalable insulin – a completely painless drug delivery mechanism. However, that joy was short-lived as Exubera was never adopted significantly by doctors and patients and the drug died a silent death.
So what led to the sad demise of this potential blockbuster? I would have thought that my fellow sufferers on injectable insulin would have been overjoyed like me and lapped up the revolutionary drug. What went wrong – was it the product launch strategy? I think the DTC ad campaign came a tad late in the game. The drug may have found much better adoption by patients if the marketing messages at product launch had been targeted to the consumers – this might have resulted in better consumer pull with patients demanding prescriptions for the drug from their physicians. But who knows….
GlaxoSmithKline is already facing numerous dangerous drug lawsuits because it had not previously warned users that the drug could place them at risk of heart disease. One lawsuit is seeking more than $100 million in damages for hiding the risks associated with Avandia. One wrongful death lawsuit in involves a Texas widow who says the drug killed her husband. Warnings of heart failure risks was recently added to the Avandia drug label.
I have heard that Actos gives bettercontrol of blood sugar and lipid levels than using GlaxoSmithKline's diabetes drug Avandia...
New research has cast doubt over the safety of Avandia commonly used to treat type 2 diabetes in adults.It can weaken bones and may lead to osteoprosis...y to invite such risks by ourselves den by taking this drug?
You write very well.
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