I believe the Food and Drug Administration (FDA) has made a mistake by bowing to pressure from consumers. "Huh?" you say and with good reason. Just about every entry I have written about a health issue has been from a pro-consumer perspective. Have I decided it is time for me to befriend the megacorps that manufacture prescription drugs? No, not at all. This situation is rare because I believe the federal agency has made a decision to please a vocal minority of drug users that is actually anti-consumer.
WASHINGTON -- Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, especially when they first start the pills or change a dose, the government warned Monday.
The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.
The drugs of concern are newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, which are called SSRIs or SSRI-like drugs, and Remeron, Serzone and Wellbutrin, which operate differently.
The pressure was brought by families of people who have committed suicide while using antidepressants. There was special pleading by parents of dead children that proved to be particularly effective. Though no studies have established a link between antidepressants and suicide, the British claim there may be a causal connection between being a minor on antidepressants and committing suicide.
British health authorities sounded the alarm last year, saying long-suppressed research suggests serotonin-affecting antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Excepting one drug, Prozac, that has been proved to alleviate pediatric depression, Britain declared the other six SSRIs or SSRI-like drugs unsuitable for depressed youth. Britain didn't mention the other three drugs in the U.S. notice.
The FDA issued a caution on pediatric use last year but says it doesn't have proof the drugs are to blame. Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. A total of 109 patients experienced one or more possibly suicide-related behaviors or attempts -- but the studies varied dramatically in what was considered suicidal behavior. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.
Though there is no conclusive evidence that any of the ten drugs cited has caused even one suicide, the FDA's recommendation will likely lead manufacturers to comply. They will not want the negative publicity that may ensue if they don't. Furthermore, by seeking a general warning, the FDA is applying the poorly researched claim to all users of antidepressants, minor and adult. For me, this is an easy call. The answer should have been 'No.' During the years I spent working on personal injury, product liability and wrongful death cases, I developed an appreciation for having a reason for holding defendants responsible for harms they legitimately cause. Allowing warnings on drug labels without a basis in research is the first step toward assigning liability without a reason in wrongful death cases involving suicidal users of antidepressants. I believe the irrationality of that will be a blow to plaintiffs with real reasons to sue and further fuel the drive for 'tort reform.'
How can I be unmoved by facts like those that influenced the FDA's decision?
. . .critics flooded an FDA meeting last month demanding stronger action -- and days later, the issue again made headlines when a 19-year-old woman taking part in a study of Eli Lilly & Co.'s experimental antidepressant duloxetine hanged herself in a company-run facility.
The evidence suggests that persons who commit suicide while taking antidepressants were risks for killing themselves before they began the medications. The drugs don't cause the deaths, their preexisting conditions do. Indeed, publicity that encourages the public to believe antidepressants cause suicide may actually lead to more deaths by frightening people who should use the drugs away from them.
"We do a disservice to a population of people who could benefit from these medications" by overreacting, said Dr. Bela Sood, chairwoman of pediatric psychiatry at Virginia Commonwealth University.
Not every national government pressured has succumbed.
New Zealand has decided not to ban a group of anti-depressants that prompted a ban in the UK and warnings in the USA, after a study found potential links to teenage suicide.
The Ministry of Health said today that after reviewing international data, it did not plan to change the way the anti-depressants, known as Selective Serotonin Re-uptake Inhibitors (SSRIs) were prescribed to teenagers here.
The parents of the suicide victims may feel they have won by pressuring the FDA to intervene. However, their 'victory' is a pyrrhic one. Though it may comfort them to shift blame to the drugs for the loss of their offspring, they are ignoring what appear to be the real reasons for suicide, and, undermining remedies that might prevent future deaths.
