Note to pharma marketing pros: Avoid using the word "off-label" in your emails. As Bloomberg reports, some messages discussing potential off-label promotions for the birth control pills Yaz and Yasmin have found their way into a lawsuit over their safety. Some 10,000 suits allege Bayer downplayed risks of the drugs--which recently have been linked to a 74% increase in blood clots--while promoting them aggressively.
Yaz is the subject of one set of emails obtained by Bloomberg, discussing the pill's potential as a PMS treatment. Approved as a therapy for severe PMS symptoms--premenstrual dysphoric disorder--Yaz could be used for garden-variety PMS, the emails suggest. Reps might use a woman's magazine article that supported that off-label use, one official at Bayer's Berlex Laboratories suggests.
Another executive, reporting on a contract with women's health blogger and "Today" show contributor Dr. Judith Reichman, wrote, "[s]he definitely will mention the off-label benefits of our products." As the news service reports, Reichman mentioned Yasmin in an article for MSNBC.com, saying it "may be helpful in diminishing PMS-like symptoms."
Bayer's own DTC marketing for Yaz crossed the off-label line, FDA said in 2008. The agency ordered the company to pull the ads and run a series of corrective TV spots to let women know the pill had not been approved as a treatment for all types of PMS or for acne.
Bayer has said Yaz and Yasmin are "safe and effective when used as directed and according to product labeling." The company wouldn't comment for Bloomberg on the pending litigation. The first trials are scheduled to get under way in January. Meanwhile, the FDA will convene an advisory panel Dec. 8 to discuss the latest safety data on the Yasmin line.
- read the Bloomberg coverage