The FDA's Little Black Box

FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs

Article Summary

Antiepileptic drugs (drugs used to treat epilepsy) can cause an increase in suicidal tendencies for clients who use them. The FDA considered putting their highest warning level (a Black Box Warning) on this drug category, but seem to have decided not to do so.

Well, first let’s start off with what a "Black Box Warning" is. The Black Box Warning is so named because, believe it or not, 4 black lines border the text of the warning in a square shape—a box, if you will.

Some medications have incredibly adverse affects—some life threatening. Accutane (used to treat severe acne) is one of these drugs.

I don’t know if any of you are on Accutane. If you’re not, then you may not know that, though effective, it is a nasty drug. Doctors won’t even write you a prescription for it unless you are using two methods of birth control, or have had a hysterectomy/been in menopause for a year (your partner’s vasectomy, or having your tubes tied doesn’t count; birth control for you). You have to join a program called iPLEDGE and submit yourself to frequent pregnancy tests while taking it. Accutane, even just one dose, causes severe, life-threatening birth defects (like the skull not forming), and often leads to spontaneous abortions.

The part about birth defects and spontaneous abortions is listed in a very visible black box on the package insert for Accutane.

Antidepressants are another class of drugs that have a Black Box Warning on them. Children and adolescents have a significantly increased risk of suicide while taking antidepressants.

The Black Box Warning is serious business, and not taken lightly at all. It has some negative effects to it, such as people may not get prescribed something they need because the doctor doesn’t want the liability.

In the case of antiepileptic drugs, the FDA decided not to issue a Black Box Warning, saying that the studies provided didn’t give proof of enough suicide risk to merit such a high warning. They were also afraid that clients currently taking medications to prevent seizures would stop their medications.

Instead, the FDA voted to offer medication guides to doctors, informing them of the risks. It will be the doctors’ responsibility to let clients know these risks when prescribing medication.

Antiepileptic drugs are used to treat, not only seizure disorders, but bipolar disorder and migraines, as well.

Another article regarding this decision can be found here.

I agree with the decision made, and think that letting doctors know of the risk is a kind of happy medium, but what are your opinions on this decision? They said the risk of suicide was not high enough to attach a Black Box Warning to the medication, but how much of a risk do they need? Should the panel have put their highest warning on the box?