After decades of inattention to the possible psychiatric side effects of experimental medicines, the U.S. Food and Drug Administration is requiring drug makers to study closely whether patients become suicidal during clinical trials…

The drug industry is keenly aware of the change. For the first time, the agency is asking makers of drugs dealing with obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions to put comprehensive suicide assessments into their clinical trials…

The seeds for the new U.S. effort were planted four years ago with the discovery that antidepressants might cause some children and teenagers to become suicidal. Top agency officials at first discounted the finding but commissioned researchers to reanalyze the drugs’ clinical trials. This work led the drug agency and its experts to view the risk as real.

Suddenly, agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems.

These are civil servants charged with keeping us from being killed by the latest nostrums cobbled together by the legal drug trade.

Yes, they’re not often doctors; but, wouldn’t you think something about medicine and possible side-effects might have rubbed off over time? Eh?




  1. BubbaRay says:

    “As agency medical reviewers pored over the drug’s clinical trial data, they discovered hints that it could cause psychiatric problems, too.

    The assessment found that the drug rimonabant doubled the risk of suicidal symptoms.”

    Great, you’re fat and you hate yourself so much that you’re ready to kill yourself too.

    New label? Warning: may cause death.

  2. Don says:

    I have read from multiple sources that medical studies will routinely exclude deceased patients from the final study results if they die from a condition not included in the study as incomplete data. Hmm, if they weren’t looking for suidide before, those subjects were mostly excluded from study results.

    Don

  3. nathaniel says:

    A suicidal person is not thinking with “common sense”, and is often unaware of what is causing those thoughts and feelings. It’s most important to warn people ahead of time about the drug risks, so if such thoughts emerge they can identify them instantly and stop taking the drug. They need to know which drugs cause (or release) those types of thoughts.

  4. Angel H. Wong says:

    Basically they’re telling the drug companies to make a more “don’t blame us if you kill yourself” contract to those who will try their experimental drugs.

  5. sargasso says:

    Off the monitor, FDA approval rubber stamps approval in maybe another dozen countries.

  6. zybch says:

    I’ve suffered with depression for almost 10 years now and while I’ve never actually suicided (well obviously) the periods in which I believed suicide was a viable option were definitely linked to specific anti-depressants I was prescribed at the time.
    Its disturbingly ironic that some of the drugs that were supposed to bring a degree normality to my life were also the ones that not only made me gain weight so I looked like the late Orson Welles after an all-you-can-eat-plus-a-free-chicken-buffet, but that also made me so much more depressed that suicide looked like a logical solution.
    Self medication with alcohol and pot has been a much more beneficial scheme than the commonly prescribed commercial drugs.

  7. bobbo says:

    #7–zybch==and you haven’t lost your sense of humor either. Yes, find comfort where you may.

  8. DeLeMa says:

    #7 –
    I will echo the sentments of # 8. Be as well as you can and dream only the best of dreams.


0

Bad Behavior has blocked 4395 access attempts in the last 7 days.