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FDA panel urges warnings for Yaz, Yasmin; now what?

Consumer Reports News: December 16, 2011 06:25 AM

Well-known birth control pills such as Yaz and Yasmin need stronger warnings about the risk of blood clots, an FDA advisory committee reportedly recommended last week. This comes on the heels of the agency’s recently released analysis showing the drugs pose a greater risk of clots compared to older birth control pills. The FDA acknowledged that other studies have not found such an increase. With all the controversy, where does this leave women who take Yaz and related oral contraceptives?

Most birth control pills combine two types of hormones: estrogen and a progestin. Newer pills pair estrogen with the progestin drospirenone, a synthetic hormone that may minimize side effects such as fluid retention, breast tenderness, weight gain and increased blood pressure. Other drospirenone-containing pills include generic Gianvi, Loryna, Ocella, Syeda, Zarah, and Beyaz and Safyral. Some are also approved to treat moderate acne and premenstrual dysphoric disorder.

Use of any combination birth control pill increases the risk that a blood clot will form in a deep vein of the leg. But overall, that risk is relatively small: between 9 and 10 women in 10,000 per year, compared to about 0.5 to 3 women in 10,000 per year who do not take any birth control pills. However, if the clot breaks off, travels to the lungs and blocks blood flow, it can be deadly. These conditions are considered types of venous thromboembolism (VTE). Some studies have also linked certain progestins used in birth control pills to a higher risk of VTE.

But many of those studies had problems, according to both the FDA and an analysis of the evidence conducted for Consumer Reports by the American Society of Health-System Pharmacists. Most studies did not consider all risk factors the subjects may have had for VTE. Some failed to identify the types of pills used in the comparison group or confirm diagnoses of VTE. And many had too few cases of VTE to accurately assess differences in risk.

Although the absolute risk of VTE may be small and even debatable among medical professionals at this time, there are steps you can take now to reduce your exposure if you are concerned:

Talk to your doctor. If your birth control pill contains drospirenone, the FDA advises that you continue to use it unless told otherwise by your healthcare provider. If you’re considering using a drospirenone-containing pill, your doctor should weigh its risks and benefits in light of your personal risk for developing blood clots.

Address your risk factors. The risk of a blood clot with combination birth control pills is highest during the first year of use—especially in the first three months—and when you restart the pill after a break of four weeks or longer. But the more risk factors you have, the greater your risk. These include smoking, being obese or overweight, and health problems such as diabetes.

Stay active. Regular exercise such as walking improves circulation and reduces the risk of VTE. Move your legs often if you have to sit or lie down for an extended period of time.

Avoid the pill immediately after childbirth. The risk of VTE escalates in pregnant and postpartum women.

Know the symptoms of VTE. Seek medical attention immediately if you have swelling, pain, warmth, redness or discoloration of one leg, swollen-looking veins in the leg, or pain or tenderness in the calf muscle or groin. Symptoms of a clot in the lung include sudden shortness of breath, sharp chest pain, coughing up blood, and less commonly, dizziness, back pain or wheezing.

Bottom line: Serious blood clots are relatively rare in young women with limited risk factors. Recent trials report an increased risk of VTE with drospirenone-containing birth control pills compared with older versions of the pill, although the results of previous studies are conflicting. If you’re concerned, discuss risks and benefits with your doctor, and consider a pill or birth control method with a more consistent safety profile.

For more information on drug safety and effectiveness, see Best Buy Drugs.

--Sue Mittenthal


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