WASHINGTON, January 3, 2005 (LifeSiteNews.com) – Barr Pharmaceuticals Inc.‘s advertisement for its birth control pill, Seasonale, is misleading to consumers, the US Food and Drug Administration warned in a letter released Thursday, because it fails to warn that the drug causes “frequent and sometimes substantial bleeding,” according to a Reuters news report.
The FDA letter warned Barr that their television commercial advertising the abortifacient/contraceptive pill misleads by making the pill appear safer than it really is. “The TV ad is false or misleading because it fails to reveal material facts about Seasonale and minimizes the risks associated with Seasonale, in violation of the Federal Food, Drug and Cosmetic Act,” according to the FDA letter. “By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
The FDA’s warning highlighted the results of a clinical trial comparing the 91-day Seasonale® pill regimen with the more common 28-day regimen, which found a significant number of women discontinued Seasonale® prematurely because of “unacceptable bleeding.”
In fact, 35 percent of women in the study taking Seasonale® had abnormal bleeding for greater than 20 days, versus only six percent of those taking the 28-day abortifacient/contraceptive.
“In addition,” the FDA letter continues, “the risk information that is presented in the ad is minimized by the compelling visuals, fast-paced scene changes, and other competing modalities, such as background music and SUPERs, occurring simultaneously during the presentation of risk information in the TV ad. This complex presentation distracts from and makes it difficult for consumers to process and comprehend the important risk disclosures.”