Top-selling birth-control pills battle new image problems

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth-control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a treatment to combat acne and severe premenstrual depression.

Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer's successful positioning of Yasmin and Yaz as the go-to drug brands for women younger than 35.

But recently, the Yaz line's image has been clouded by concerns from some researchers, health advocates and plaintiffs' lawyers. They say the drugs put women at higher risk for blood clots, strokes and other health problems than do some other birth-control pills.

Those critics, though, are up against a large European study, sponsored by Bayer, the German pharmaceutical company, that reported the opposite conclusion. The Bayer-financed study said cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth-control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration (FDA) cited Bayer this year for running misleading television commercials and last month for not following proper quality-control procedures at a plant that makes hormone ingredients.

In e-mail responses, the U.S. unit of the company said that its birth-control drugs had been and continued to be extensively studied and the company stood behind their safety. The company also said it had responded to the FDA's questions about manufacturing practices.

Even if Bayer can adequately respond to the safety and other concerns, some industry analysts say the criticism could tarnish the Yaz line's image. Other products by Bayer, such as the erectile dysfunction drug Levitra and the intrauterine birth-control system Mirena, generate far less income than the Yaz product family.

"For Bayer, it is by far the highest margin and the fastest-growing brand," Martin Brunninger, an analyst with the European investment bank Bryan, Garnier & Co., said in a phone interview from London. "Whether this turns out to be a serious issue or not, when a drug is stigmatized in public, people just withdraw from taking it."

Bayer said the company had been served with 74 lawsuits brought by women who charge they developed health problems after taking Yaz or Yasmin. The company says it intends to defend itself vigorously.

The health questions and lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer's approach to complying with government rules, said Michael Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry.

Birth-control pills work by altering a woman's hormone levels. Researchers have long known that taking a combination hormone birth-control pill — which contains estrogen and a progestin hormone — can increase the risk of stroke and blood clots in the legs and lungs. That is because estrogen can play a role in blood coagulation. Indeed, since the introduction of oral contraceptives in the 1960s, drug companies have greatly reduced estrogen doses to decrease the risk of thrombosis, the medical term for blood clots.

With lower-dose estrogen pills available, the safety debate, continuing for the past decade, has focused on whether the type of progestin in a formula may also play a role in the risk of cardiovascular problems.

In 2001, the FDA approved Yasmin, which contains a novel progestin called drospirenone.

Yaz, which contains drospirenone and a lower dose of estrogen, received agency approval in 2006. For women seeking contraception, the drug is also approved to treat moderate acne and severe emotional and physical symptoms called premenstrual dysphoric disorder. Because drospirenone can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems, according to the drug label.

Studies on the safety of birth-control pills have reported different results on the risks of progestins.

One large-scale study in Europe, sponsored by Bayer, reported there was no difference in the risk of cardiovascular problems or death in women taking drospirenone birth-control pills compared with women who took pills that contained levonorgestrel, a progestin that has been used since the 1970s.

But two other studies on Danish and Dutch women, published last month in The British Medical Journal, found a higher risk of venous blood clots for women taking newer progestins, including drospirenone.

The results of the new studies, conducted on European populations with specific genetic risk factors for blood clots, might not translate to a more ethnically diverse American patient population, said Dr. David Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina medical school. And even if the reported increased risk is realistic, he said, it is tiny.

"My dictum is that a multiple of a rare event is still a rare event," said Grimes, who has been a paid consultant for Bayer and other makers of contraceptives. And taking birth-control pills involves much smaller blood-clot risks than getting pregnant and having a baby, he said.