Although studies have linked the popular birth control pills Yaz and Yasmin to an increased risk for blood clots, the FDA recently ruled that they're safe… sort of. We explain why they're potentially risky, who shouldn't take them, and more.
THURSDAY Dec. 15, 2011 — After an FDA panel reached a far-from-unanimous verdict last week that newer birth control pills and the birth control patch are safe (or, at least, that their benefits outweigh their risks), many women were still left feeling uneasy about their contraception choice.
The Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met to discuss the safety of popular birth control pills — Yaz, Yasmin, and other newer forms of oral contraceptives. Introduced in 2006 and marketed to help clear acne and reduce PMS symptoms, Yaz quickly became the bestselling birth control in the United States, with sales of $781 million in 2009, according to Time magazine.
But recent research has linked drospirenone, a newer type of the hormone progestin used in the pills, to a slight (but still alarming) increase in the risk of blood clots, or venous thromboembolism, in the legs and lungs. According to the FDA review, about 10 in every 10,000 women taking drospirenone-containing birth control will experience a blood clot, compared to 6 in every 10,000 women on traditional forms of oral contraceptives (which do not contain drospirenone).
The panel also weighed in on potential blood clot risks from the contraceptive patch Ortho Evra, introduced in 2001. The patch doesn’t contain drospirenone, but has higher levels of estrogen than in traditional birth control pills, which could also increase the risk of blood clot risks, according to the FDA report.
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Although the panel members decided that the benefits of drospirenone-containing contraceptives outweigh the risks in a 15-11 vote, they were also overwhelmingly in favor of drug companies revising labels to better reflect blood clot risks. They reached a similar conclusion for the patch, with a 19 to 5 vote, also calling for more research, as the studies didn’t take into account risk factors like smoking, family history, or others.
“These drugs got our attention when they hit the market [in 2006],” says Marcelle Pick, RNC, an ob-gyn nurse practitioner at the Women to Women Clinic in Yarmouth, Maine. “We were all pretty excited about them. Now we need to step back and say, ‘Wait a minute — they aren’t quite what we thought they were,” says Pick.
Here, experts answer your biggest birth control safety questions.
So which drugs contain drospirenone? According to the FDA, drospiernone-containing birth control pills include Yaz (and its generics Gianvi and Loryna), Yasmin (and its generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.
Though Yaz was once the best-selling birth control in the country, prescriptions have dropped more than 80 percent in the last two years as safety concerns have surfaced, according to the Associated Press.
The health risks seem pretty small — should women really be worried? Ten in 10,000 women taking drospirenone-containing drugs will experience a potentially deadly blood clot, according to the FDA review — that’s a 75 percent increase over women taking other forms of oral contraceptives (the review reported a 55 percent increase with the patch). Still, that risk is small, especially when you consider other blood clot risk factors. For example, about 20 in every 10,000 women who are pregnant or just gave birth develop blood clots. Even everyday airplane travel poses a threat: one in every 4,500 people develops a blood clot after flying, according to the World Health Organization (WHO).
But a small risk is still serious. Blood clots can lead to stroke, heart attacks, pulmonary embolism, and even death.
“The overall risks [from birth control] are low,” says Shari Brasner, MD, an ob-gyn at Mount Sinai Medical Center in New York City. “But it’s still important to be honest [about your health history and risk factors] with your healthcare provider so she can assess your individual risks and benefits.”
- What are those risks factors? Any woman with blood clotting disorder or a family history of blood clotting should stay away from all combination oral contraceptives — not just those that contain drospirenone. Smoking also compounds these risks; smokers who use such birth control pills are at even greater risk of blood clots, stroke, and heart disease than non-smoking pill users. Age is another risk factor to consider: women over 35 may be more at risk for clots in the first place, and that risk increases with hormonal birth control.
- Will doctors still prescribe pills like Yaz? It depends on who you ask. Dr. Brasner agrees with the panel’s majority: If a young woman is healthy, the benefits of the pill or patch outweigh the clot risk. And all oral contraceptives carry some risk, she explains. “I try to discuss all options and include a discussion of pertinent risks to allow each woman to make an individual decision.”
In fact, a recent Bloomberg Buisnessweek article found that many ob-gyns are unfazed by these growing concerns. Of the nine doctors surveyed for the article, all said the evidence isn’t conclusive or worrisome enough to stop prescribing the pills — plus, blood clots have been a known risk factor for birth control pills for 50 years. “A lot of people come in and say, ‘I love this pill and would prefer not to come off it,’” Robert Barbieri, MD, a professor of obstetrics, gynecology and reproductive biology at Harvard Medical School told Bloomberg Buisnessweek. “They understand it’s a slight risk but not a huge one.”
But Pick feels differently. “I’m very cautious; I’ll tell you that upfront,” she explains. “If my patient has another option, I’m going to heed this information and not prescribe Yaz or Yasmin.” She also said that she’d recommend her patients currently taking these pills to switch to a different kind with fewer risks.
What are the alternatives? There are many different birth control options, and determining which one is right for you is a decision you should make with your doctor. Together, you will talk about your health status — factors including your history of blood clots, heart disease, or stroke, your blood pressure, your smoking habits, and whether you are breastfeeding or want to have children in the future — to weigh how each birth control method could affect your health.
Beyond different kinds of pills and the patch, birth control options include hormone shots, hormone implants, and increasingly popular intrauterine devices (IUDs), which come in hormonal and non-hormonal forms. In a recent practice bulletin, the American Congress of Obstetricians and Gynecologists (ACOG) said that IUDs are the most effective reversible contraceptive available, safe for almost all reproductive-age women. And of course, there are always traditional barrier methods, including condoms, contraceptive sponges, and diaphragms.
Learn more in the Everyday Health Sexual Health Center.