The United States Food and Drug Administration has renewed its scrutiny into Yasmin, Yaz and other birth control pills with newer formulations, warning that these may increase the risk for blood clots.
The new investigation was ordered when a federal judge in Illinois who is overseeing a consolidation of Yaz cases unsealed on Dec. 5 several court documents that suggested Bayer may have withheld data from FDA about the blood clots risks of its drugs.
The documents stem from expert opinion gathered by personal injury lawyers suing Bayer AG, the manufacturer of Yasmin and Yaz, on behalf of patients who experienced blood clots after using the drug.
Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives, including FDA reports of at least 50 deaths linked to the pills from 2004 to 2008. The first trials are scheduled for next month in federal court in Illinois and state court in Philadelphia.
According to one court document, Bayer drafted a white paper in 2004 to address “FDA concerns,” about clots with Yasmin. This paper did not include information found in an earlier draft that reported that blood clots associated with Yasmin use were significantly higher than those linked to three other oral contraceptives.
An Associated Press article cited Dr. David Kessler, a former FDA commissioner, in his expert testimony as saying: “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”
The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler said.
Another document unsealed by the Illinois judge was a report by John Abramson, a Harvard medical school professor claimed that Bayer’s Berlex unit came up with a plan to hire Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women’s health issues, “to engage in off-label promotion” of the Yasmin line of contraceptives for $450,000.
This promotion was “designed to circumvent FDA restrictions on marketing” because Bayer saw the limits “as a threat to the commercial success of Yaz,” he said.
Abramson was hired by plaintiffs’ lawyers to review materials Bayer turned over about the marketing of the drugs.
In her 2005 book, “Slow Your Clock Down,” Reichman wrote that Yasmin may help women with PMS-related symptoms such as “fluid accumulation and bloat” or with depression. Internal emails showed that the company knew the value of her off-label promotions was “astronomical,” the Abramson report said.
Bayer did not immediately comment on the unsealed documents, noting that the issues would be addressed at trial. The FDA spokesperson also did not comment. The agency also refused to accept the court documents for this week’s hearings, saying that the deadline had passed by a month, according to an e-mail sent to plaintiffs’ lawyer Ned McWilliams on Monday.
The Kessler and Abramson reports were sent to the FDA by McWilliams, a lawyer with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor PA in Pensacola, Florida.
On Thursday’s FDA hearing, Cindy Rippee is expected to testify about her 20-year-old daughter, Elizabeth, who died Christmas Eve 2008 when a blood clot traveled to her lung. Rippee says her daughter had been taking Yasmin for about two months.
“I really feel that if my daughter had been told about the increased risk she would have made a different decision,” said Rippee, of Escondido, Calif.
Related Reading:
Yasmin & Yaz Side Effects: Blood Clots?
Story Sources:
Market Watch
Washington Post
Canadian Broadcasting Corporation
Bloomberg News