The popular birth control pill, Yaz is in the news again. Readers may remember that last autumn, Bayer (the maker of Yaz) was sanctioned by the FDA for their television commercials, “because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz.” The FDA actually required Bayer not only to end the advertising campaign immediately but to make amends by publicizing corrective information — an unusually bold move from the FDA. That led to the ad shown at right.
Bayer was cited by the FDA again earlier this year, for failure to follow proper quality control in the plant that manufactures the synthetic hormones used in Yaz.
Bayer is now defending itself against 74 lawsuits filed by users who developed health problems, such as blood clots or heart attacks. Bayer is taking the FDA citations seriously and plans to “defend itself vigorously against the suits.” Dr. David A. Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina medical school and paid consultant to Bayer says the risk of injury from Yaz is tiny. “My dictum is that a multiple of a rare event is still a rare event,” says Grimes. And the New York Times seems far more concerned with how the FDA citations and the lawsuits will affect Yaz’ image and sales than they are with women’s health.
Didn’t these people learn anything from the saga of the Dalkon Shield?
October 2, 2009
Edited to Add: The New York Times report neglected to mention that Swissmedic is investigating the death of a young woman from the effects of pulmonary embolism that may be linked to her use of Yaz.
