By E. Christian Brugger
WASHINGTON, D.C., JUNE 29, 2011 (Zenit.org).- It’s nice to know that the trusted aspirin maker, Bayer, is watching out for our daughters. The oral contraceptive producer of YAZ, Beyaz and Yasmin has been cited since 2008 by the FDA for failing to adequately address certain risks of its pills’ active hormone drospirenone, a so-called “fourth generation” contraceptive drug.
Things have gotten so bad that even CBS News house doctor Jennifer Ashton judged the story newsworthy. On the June 2 Early Show Ashton reported that the FDA has issued a new safety warning against the pills because of fear of increased risk of dangerous blood clots. The review was prompted in part by the publication of two articles in the April 2011 British Medical Journal (1, 2) (BMJ) comparing the safety of oral contraceptives using drospirenone with contraceptives using levonorgestrel (the most common “second generation” synthetic progestin).
The two articles were published in the wake of the tragic death last September of an 18-year-old New Jersey girl, Michelle Pfleger, who collapsed at college in cardiac arrest from a massive blood clot in her lungs believed to be caused by taking YAZ. The pharmaceutical behemoth responded to the two articles saying that its drugs are no more dangerous than other oral contraceptives. Encouraging. On May 10, Michelle’s mother filed a wrongful death suit against Bayer claiming that YAZ caused her daughter’s death.
Deaths from YAZ and Yasmin are not new or news to Bayer. Between 2004 and 2008 the FDA received reports of more than 50 deaths of women, some as young as 17, who had been taking the Bayer contraceptives. In 2009 the company disclosed that 129 lawsuits had been brought against it because of problematic side effects and marketing of YAZ and Yasmin. The lawsuits allege everything from deception in advertizing, to shoddy research and development, to culpable failure to recall the drugs after post-marketing reports demonstrated a risk of potentially life-threatening side effects.
Yasmin received FDA approval in 2001. Shortly after that a European medical association, the Dutch College of General Practitioners, advised its doctors not to prescribe the new drug because multiple cases of blood clot, including lethal cases, had been reported in Europe among women taking the oral contraceptive. In 2002, a series of case reports raised concerns about blood clots among users. And just last month, the European Medicines Agency (EMA) announced a product update on oral contraceptives containing drospirenone because of — yes — the risk of blood clots.
My friend Richard Doerflinger, hearing that the FDA was investigating the Bayer drug (again) for posing to women an ‘unacceptable risk’ of lethal blood clots, quipped, “You mean the FDA thinks there’s an acceptable level of risk?!” Apparently. The BMJ studies concluded that women who use oral contraceptives such as YAZ have a two- to three-fold higher risk for developing potentially serious blood clots than women taking earlier-generation drugs.
Jennifer Ashton said this translates into an 8 in 10,000 chance of blood clots for the older drugs and a 16 (to 32) in 10,000 chance for YAZ-type drugs. In defense of YAZ, Ashton said soothingly: “An increased risk of a rare event is still a rare event.” Say that to Michelle Pfleger’s mother.
Do you recall the Tylenol crisis in 1982? Seven people in Chicago were reported dead after taking extra-strength Tylenol apparently laced with cyanide. Johnson & Johnson recalled tens of millions of bottles at a cost of nearly $100 million dollars. How does Bayer respond to deaths apparently caused by YAZ-type contraceptives? By printing the following warning at the top of its Web site: “Beyaz and YAZ are associated with increased risks of several serious side effects, including blood clots, stroke and heart attack.”
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E. Christian Brugger is a Senior Fellow of Ethics and director of the Fellows Program at the Culture of Life Foundation; and the J. Francis Cardinal Stafford Chair of Moral Theology at St. John Vianney Theological Seminary in Denver, Colorado.[Readers may send questions regarding bioethics to email@example.com. The text should include your initials, your city and your state, province or country. The fellows at the Culture of Life Foundation will answer a select number of the questions that arrive.]