D rug safety seems to be in the news a lot lately — too much probably. As far as I can tell, no drug is safe. All drugs are toxic, at least to some degree. Common antibiotics can cause life-threatening allergic reactions, aspirin is far from benign, and even topical corticosteroids cause adverse reactions.

If drugs had to be completely safe, we’d have no drugs.

If cars had to be completely safe, we wouldn’t have any of those, either.

Weighing the Risks Versus Benefits
While drugs aren’t “safe,” they are safe enough when the benefit exceeds this risk. This isn’t always an easy judgment, but it is one that physicians and patients have to make every day.

For better and worse, society insinuates itself into the equation. Terrible, albeit rare, birth defects make much better newspaper copy than does curing countless patients of severe acne. The resulting political economy of drug safety can result in legislative and regulatory decisions that are very different than the decisions made by well-informed patients and physicians. On page 40, Dr. John Hancox details the new regulations and risk program for isotretinoin, and experts weigh in with their opinions on what effects this will have on prescribing habits for this drug.

Two Sides to the Story
Without doubt, isotretinoin has the potential for truly horrific toxicity. Dermatologists also see isotretinoin’s other side, the potential for extraordinary benefit. There is no doubt that isotretinoin’s benefit outweighs the drug’s risk for many patients with profound scaring acne.

One isotretinoin birth defect may be one too many. One automobile death is one too many, too. Life has risks, and we can’t eliminate them completely. For the benefit of our patients, rationality needs to take precedence over political economy.

Steven R. Feldman, M.D., Ph.D.