Sanofi gets FDA warning over Uroxatral promotion

The U.S. Food and Drug Administration has sent a warning letter to Sanofi-Aventis accusing the French drugmaker of distributing misleading promotional material on its Uroxatral treatment for urinary problems caused by an enlarged prostate.

At issue is a promotional card that touts the benefits of Uroxatral on the front, but only lists proper use of the medicine, risks associated with the drug, and those who should not be taking it, on the back.

While noting that the use and risk information is included, the FDA warning letter said the so-called tent 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.”

Presenting the indication and risk information in this manner “is not sufficient to ensure that the claims in each part of the tent card are truthful and non-misleading,” the FDA said.

In addition, the FDA said the situation cannot be corrected merely by including the 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 information could misleadingly encourage the use of Uroxatral 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.

The FDA has requested that Sanofi immediately cease dissemination of the violative promotional material and submit a written response to the agency on or before Nov. 6, stating whether it intends to comply.

“Sanofi-Aventis is currently evaluating the letter and will determine an appropriate next step,” a Sanofi spokeswoman said.

The company said the card was primarily placed in physician offices this past summer.

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NEW YORK (Reuters)