Uroxatral Risks Not Adequately Disclosed in Advertisements: FDA Warns

The FDA issued a warning letter to drug maker Sanofi-Aventis over the use of certain promotional materials for its prostate drug Uroxatral, which were described as “misleading” for failing to properly indicate the risk of potential side effects.

The warning was issued over a promotional “tent” card, which asks consumers if they are constantly going to the bathroom at night on the front, suggesting that Uroxatral could provide relief. However, all of the risks and information about the proper uses for the medication was only contained on the back. The card is designed to be placed on a flat surface, at doctor’s offices or pharmacies, which would prevent readers from seeing the important health risk information.

According to the FDA warning letter (PDF), Sanofi has been asked to stop distributing the cards and they must repond to the federal regulators by November 6.

Uroxatral (alfuzosin) is a prostate drug that is only approved to treat an enlarged prostate, known as benign prostatic hyperplasia. The drug relaxes muscles in the prostate and bladder to make it easier for the user to urinate. However, the drug needs to be used with caution among individuals with liver or kidney problems, among other contraindications.

Known Uroxatral side effects include impairment of thinking or reactions, and the drug can affect the pupils of the eyes for people who have had cataract surgery. Those with liver disease or taking certain antifungal medications are also advised not to use the drug.

In addition to hiding the risk information, the FDA says that the promotional language used was too vague. Asking things such as “Always in the bathroom…especially at night?” could make readers believe Uroxatral is for use for a number of conditions, such as an overactive bladder or urinary incontinence.