From: Attorney

The maker of the enlarged prostate drug Uroxatral has been sent a warning letter from the Food and Drug Administration about promotional materials for the drug, which bragged about its benefits but did not sufficiently detail its risks.

The FDA has objected to a promotional card, also called a tent card, which Sanofi-Aventis placed mostly in doctor’s offices and other locations over the summer.

The promotional card prominently listed the benefits of Uroxatral on the front, but only listed the risks associated with the drug, the proper use of the medication, and information on patients who should not take it on the back, according to a Reuters news report.

The FDA said the promotional card is designed to be stuck to a pharmacy countertop or other flat surface, meaning “as a practical matter, viewers of the front side of the card are unlikely to be able to view the back side of the card once it is stuck in place.”

Including the risks and side effects on the back of the card “is not sufficient to ensure that the claims in each part of the tent card are truthful and non-misleading,” the FDA said in its warning letter.

The FDA also said it was not sufficient for the company to include the phrase “please see important safety information on back” on the front of the card as a way to direct patients to the risk and other information.

The offending promotional cards also tend to overstate the approved uses of Uroxatral, the FDA warned. Language on the card implies that the drug is approved for treating symptoms of conditions such as overactive bladder, but it is not.

Uroxatral is a pill only approved to treat signs and symptoms of benign prostatic hyperplasia, or enlarged prostate, and should be used with caution in patients with liver or kidney impairment, among other contraindications, according to the product’s approved label, Reuters said.

The FDA has asked Sanofi to immediately stop using the promotional material. The drug company has until Nov. 6 to formally respond and tell the FDA whether it intends to comply with the request.

A spokeswoman said the company is still reviewing the FDA warning letter and “will determine an appropriate next step,” according to Reuters.