A New Stevens Johnson Syndrome Threat Arises

Washington, DCStevens Johnson Syndrome (SJS) is a debilitating disease characterized by the blistering and sloughing off of large portions of skin, similar to a serious burn. The rare but extremely serious condition is often triggered by an adverse reaction to many commonly used and readily available medications. Now a new drug has been added to the list: Cialis, used to treat erectile dysfunction (ED).

In last month's issue of Safety Labeling Changes by the FDA Center for Drug Evaluation and Research, the US Food and Drug Administration warned of the potential for reactions among anyone with a serious hypersensitivity to tadalafil (Cialis or Adcirca). Among the hypersensitivity reactions is Stevens Johnson syndrome.

The FDA did not refer to specific cases of SJS or number the adverse reactions that have been reported to the agency. It did, however, note that the safety and efficacy of combinations of Cialis with other PDE5 inhibitors or treatments for ED has not been studied. The FDA added further that patients should not combine PDE5 drugs, such as Cialis and Adcirca.

The news suggests the potential for a rise in the incidence rate for Stevens Johnson Syndrome, given the average age of the North American population—and specifically, the baby boomer.

More people than ever before are hitting their retirement years in a relatively compressed time frame. People are also living longer and are generally healthier and far more active than previous generations. More often than not, people also remain sexually active longer in life. And many men require drugs such as Cialis as a prerequisite to intercourse, if they suffer from erectile dysfunction.

As more and more Americans become dependent on the prescription drug industry for their everyday existence, there is a distinct possibility for a concurrent increase in the number of SJS cases.