Sanofi-Aventis received a warning letter from the FDA’s division of drug marketing, advertising, and communications after the company distributed a misleading promotional card for Uroxatral, an alpha1-blocker used to treat urinary problems caused by an enlarged prostate.
The tent card in question doesn’t list risk information on the front and neglects to caution patients with liver or kidney problems. In its letter the FDA states, “In the absence of the full indication, these statements misleadingly imply that UROXATRAL is approved for use in the treatment of any condition that keeps the patient in the bathroom, such as overactive bladder. However, UROXATRAL is only approved for use in the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The omission of the indication on the front side of the tent card may encourage the use of UROXATRAL in circumstances other than those for which the drug has been shown to be safe and effective.”
The card allegedly omits warning information related to the drug and Intraoperative Floppy Iris Syndrome (IFIS), a complication that may be suffered by those undergoing cataract surgery. The FDA requests Sanofi-Aventis cease using the promotional materials in question, and the company is required to respond to the warning letter stating whether they will comply with the letter’s guidance to discontinue use of the flawed Uroxatral tent cards by November 6.