Wednesday, May 01, 2013

If Physicians Prescribing a Drug Need to Monitor Those Patients for Death, What Business Does the FDA Have Approving that Drug?

Today, the Rest of the Story is questioning the wisdom of keeping a drug on the market when its required black box warning admonishes doctors to observe their patients for death.

Here is the start of the black box warning that appears on Chantix:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide."

Attempted suicide? 

Let's get this straight. Physicians are instructed by the FDA to monitor their patients for attempted suicide, which is of course, in some cases, successful. In other words, doctors are being told that a significant possible side effect of the medication is death and that it behooves them to monitor their patients to see if they die from the drug.

The Rest of the Story

What good does it do to monitor a patient for death? How does that protect the patient?

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient's liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect - sudden suicide - often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

I do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

But most importantly, I don't see how the FDA can keep a drug on the market when it feels compelled to warn physicians that they need to carefully monitor their patients for possible death.

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