The agency senta warning letter to the drug maker for distributing "misleading" promotional material for its Uroxatral medication for urinary problems caused by an enlarged prostate. The problem was a promotional card touting the benefits of Uroxatral on the front, but some important stuff -risks, proper use of the med and folks who shouldn't take it - only showed up on the back of the card. Tricky, yes?
The FDA wrote the card is designed to be adhered to a flat surface, such as a pharmacy counter, "and 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." The agency called this insufficient to ensure claims on each part of the card are "truthful and non-misleading," and added that Sanofi-Aventis couldn't fix the problem by including this phrase: "please see important safety information on back."
The front of the card contains the phrases, "Always in the bathroom ... especially at night?" and "Relief begins with U." The FDA said those phrases in the absence of specific use info could misleadingly encourage usage in circumstances other than those for which the drug has been shown to be safe and effective, such as for overactive bladder.
Uroxatral is 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 adds. As Reuters notes, Uroxatral is a relatively small product for Sanofi with US sales last year of about $176 million. The drug maker is figuring out what to do next and says the card was mostly placed in doctor offices.