Prescribing medication requires balancing side effects, benefits

October 1, 2007

I recently have found myself questioning the safety profile of the drugs I prescribe. How safe does a drug have to be before I will confidently write a prescription? Conversely, how dangerous does a drug have to be before I will discontinue its use in my practice?

I recently have found myself questioning the safety profile of the drugs I prescribe. How safe does a drug have to be before I will confidently write a prescription? Conversely, how dangerous does a drug have to be before I will discontinue its use in my practice?

The Food and Drug Administration (FDA) grandfathered many of the drugs used in dermatology, since they were in wide use at the time the FDA was created. Sodium sulfacetamide, tar, salicylic acid and sulfur all fit into this category. Dermatology has more grandfathered drugs than any other specialty.

Other drugs that we prescribe are highly regulated, such as oral isotretinoin. The implementation of the iPLEDGE program has created new prescribing challenges for dermatologists who wish to continue to use the oral retinoid. If the FDA considers oral isotretinoin so dangerous that it requires completing extensive on-line paperwork and extremely meticulous patient follow-up with laboratory testing every month , is this drug too dangerous to prescribe?

Though acne isn't life-threatening, the condition can be life-ruining, can cause depression and can create suicidal ideation. Since the use of oral isotretinoin requires such attention to detail, are we setting ourselves up for lawsuits if the details do not fall into place? Is our career in the hands of an irresponsible teenager who may not complete the documents properly or follow the rules? How safe is "safe"?

The issues surrounding the 2004 withdrawal of Vioxx from the marketplace have given me further reason to question the safety of prescribing new drugs. Vioxx was a tremendous step forward in the control of arthritic pain, allowing many people to get out of bed in the morning and function. The cardiovascular side effects were certainly unfortunate, but not well understood until large numbers of people took the medication. The problems did not become apparent until years after the drug was approved.

Lawsuits are presently swirling around both the physicians who prescribed the medication and the manufacturer. I have always felt that if a drug was FDA-approved and I understood and explained the side effects to my patients, I could feel confident that my decision to write the prescription was safe. Now, I am not so sure. Should I wait five years after a new drug is introduced to begin prescribing the medication, to be sure no unknown side effects will surface? How safe is "safe"?

I think every dermatologist will need to re-evaluate the safety of prescribed medications. Safety tolerance limits may vary on a patient-by-patient and disease-by-disease basis. There is no doubt that the safety of many products is in part determined by the risk of a malpractice lawsuit. The introduction of tort reform would certainly change the safety requirements of many pharmaceuticals. In dermatology, we are fortunate, since most of our commonly used drugs have excellent safety profiles, and adverse reactions can be readily treated.

The proposed FDA removal of hydroquinone from the over-the-counter market has even the agency questioning the safety of drugs that have been on the market for more than 70 years. How safe is "safe"?