Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Many medical researchers find little surprise that Chantix has been linked to higher than normal rates of depression and suicide. Varenicline (the chemical name of Pfizer’s smoking cessation drug) goes to work directly in the brain by targeting certain receptors and simulating that feeling of having already smoked – that “full” feeling smokers feel after they’ve lit up one or two. Other pharmaceuticals that go to work directly in the brain include antidepressants, some of which have also been linked to behavioral problems and suicide.

Now the FDA is paying closer attention to the potential psychiatric effects of non-psychiatric drugs. Anti-seizure medications, asthma drugs, and Chantix are some of the drugs now under watch for adverse psychiatric effects that they may have on the brain. This begs the question: Doesn’t every drug have the potential to affect the brain? Don’t medicines taken orally or by injection work by entering the bloodstream, which then delivers the drug to the target (in addition to the liver, kidneys, brain, etc.)?

According to an AP article, “Several independent experts say the safety alarms point to a gap in the FDA’s knowledge of how drugs affect the brain.” The article goes on to posit that “even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain.”

I’m not a pharmacist or a physician, yet it still seems very elementary to me. First, don’t all drugs enter to the brain via the blood to some degree? And shouldn’t this little bit of knowledge be enough to prevent such gross oversights? The more one reads about the FDA, the more one realizes how much he has assumed about the scope of the agency’s knowledge and its effectiveness.

Until the FDA establishes an effective method for accurately quantifying rarer side effects such as depression and suicide, it is seeking a way of warning patients without alarming them or scaring them away from drugs that will likely help them. “Debunking false notions of risk is just as important to the public health as knowing about risks that exist” Kelly Postner, a researcher at Columbia University, who is working to develop a psychiatric screening system for people receiving trial drugs, told the AP.

Perhaps in the future we can expect a warning on all medications akin to the blanket warnings about peanuts and tree nuts found on food labels. The risks may be small for the vast majority of people, but no warnings can be exaggerated for the rare exceptions whose lives have been hurt or destroyed.

This entry was posted on Thursday, September 25th, 2008 at 2:33 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.