Sanofi card trick draws warning

Share this article:
Sanofi card trick draws warning
Sanofi card trick draws warning
A promotional card for Sanofi Aventis's Uroxatral omitted indication and risk information, and also used outdated product labeling, according to a DDMAC warning letter dated October 23 and posted online yesterday.

The front side of the “tent card” reads “Always in the bathroom…especially at night?” and “Relief begins with U,” without providing a full indication for the drug. “These statements misleadingly imply that Uroxatral is approved for…any condition that keeps the patient in the bathroom, such as overactive bladder. Uroxatral is only approved for use in the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH),” the letter said.

Although risk and indication information was printed on the back of the card, DDMAC determined that viewers are unlikely to see it. “The tent card is designed to be adhered to a flat surface (e.g., 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,” according to the letter.

DDMAC noted a statement on the front of the card directing viewers to safety information on the reverse side, but said the omissions “cannot be corrected” by referencing the back of the card. Information on the back of the card also failed to include an “important warning and precaution regarding Intraoperative Floppy Iris Syndrome (IFIS),” the letter said.

As a result, Sanofi must halt dissemination of the cards, and provide a written response to the letter by November 6, 2009.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...