Top-selling contraceptive stirs controversy

by publicationarchive

By Andrea Mora, Senior Staff Writer

Many women have relied on contraceptives to prevent unplanned pregnancy for more than half a century. And in 2006, one pill claimed to be “beyond birth control,” promising to treat acne and premenstrual syndrome, thus enticing more women to choose this pill instead of others on the market. But a recently filed lawsuits and a $20 million corrective ad campaign for misleading commercials have raised questions about the safety of this pill.

Yaz, a daily oral contraceptive, was introduced in the U.S. nearly four years ago from Bayer HealthCare Pharmaceuticals, also the maker of Yasmin and Minera birth control. Since then, Yaz has become the top-selling contraceptive among women, earning nearly $616 million in 2008, according to the British Medical Journal.

The Food and Drug Administration, however, recognized a problem with the Yaz ads in 2008, citing the pill was not clinically approved to treat acne or PMS. The FDA also found the ads deceptive for not stating serious side effects that may occur when taking the pill and demanded they be changed.

Yaz agreed to correct its ads last year to properly state that the pill can be used for the treatment of moderate adult acne and premenstrual dysphoric disorder.

Women who experience PMDD may feel anxious, anger, irritability, depressed moods, lack of energy, change in appetite or sleep and feeling out of control. PMDD is a mood disorder related to the menstrual cycle that can interfere with one’s life.

But women who were already taking Yaz have filed lawsuits against the pharmaceutical company, claiming they were not advised of serious side effects and blame deceiving ads. Scores of attorney Web sites can be found online that specialize in Yaz lawsuits, many claiming that Yaz is more “dangerous” than other birth control pills.

Plaintiffs against Bayer claimed to have suffered serious side effects such as a heart attack, stroke, blood clots, benign liver tumors, deep vein thrombosis, which is a blood clot in the leg and pulmonary embolism, a blood clot in the lung, according to a New York Times article.

Some are now worried that combination pills like Yaz, containing the progesterone drosperinone and a smaller dose of estrogen, may increase the risk of serious side effects.

According to a recent European study published in the BMJ, however, studies have shown drosperinone does “not increase the risk of venous thromboembolism.” Personal or family medical history may be a more important factor in determining the risk of developing blood clots.

Yaz states on its Web site, “Yaz contains a hormone that for some may increase potassium too much, so people who have kidney, liver or adrenal disease should not take Yaz, as this could cause serious heart and health problems. Serious risks include blood clots, stroke and heart attack.”

The Web site also lists more common side effects that may be related to Yaz and have a 1 percent chance of occurring. Some of these side effects include upper respiratory infection, headache, breast pain, nausea, abdominal pain, sinusitis, weight gain or depression.

“While every medication has risks, pills containing drospirenone, such as Yaz and Yasmin, are safe and effective and have been used safely by women in the U.S. since 2001,” Grassroots Coordinator for Planned Parenthood of San Diego & Riverside Counties Vanessa Forsberg said.

“Two recent medical studies evaluated the safety of drospirenone and found there was no increased risk of side effects associated with Yaz or Yasmin.”

Using birth control, such as the pill or condoms is still the safest and most efficient way to prevent pregnancy or, in the condoms case, the spread of sexually transmitted diseases.

“Pills, patches and rings are all safe and effective means of birth control for healthy women,” Forsberg said. “Women should always consult their health care provider to see which contraceptive method is best for them based on their individual needs, health and lifestyle.”