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FDA Says Yaz, Yasmin May Raise Blood Clot Risk | 24-7-news.com cialis online

FDA Says Yaz, Yasmin May Raise Blood Clot Risk

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The U.S. Food & Drug Administration (FDA) says that Yaz and Yasmin may raise blood clot risks. The controversial, newer generation birth control pills are made by Bayer.

According to the health regulator, said The Associated Press (AP), the labeling is being added to Yaz, Yasmin, and other newer oral contraceptives, such as Beyaz, Safyral, Drospirenone and Ethinyl Estradiol, Gianvi, Loryna, Ocella, Syeda, and Zarah. The revised labeling will stress that the drugs may be likelier to lead to blood clots versus older contraceptive pills. Yaz, Yasmin, and other drospirenone-containing birth control pills have enjoyed popularity over claims they clear up acne and other hormone-related symptoms, note the AP.

The newer drugs contain the synthetic female progesterone, drospirenone and the revised labeling will include information from recent studies that suggest that oral contraceptives containing drospirenone are linked to an increased risk of blood clots when compared to other birth control pills.

The agency also issued an FDA Drug Safety Communication on the updated in formation as a follow-up to its 2011 Communication, which can be accessed at: http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm.

The current Communication states that the FDA completed its review of recent observational (epidemiologic) studies and concluded that drospirenone-containing birth control pills may be linked to higher risks for blood clots than other progestin-containing pills. The FDA also suggested women speak to their healthcare professionals about risks for blood clots prior to choosing a birth control method and that healthcare professionals consider the risks and benefits of these new birth control pills before prescribing these drugs.

Drug labels for will be updated with study information reporting up to a three-fold increased risk for blood clot risks with those medications when compared to older birth control pills that contain levonorgestrel or other progestins. The labeling will also include information that other epidemiological studies that found no additional risk of blood clots with drospirenone-containing products, as well as a summary of previously released results from an FDA-funded study of the increased risk for blood clots. That study, released last fall, found that drospirenone-containing birth control pills were linked to a 1.5-fold increased risk for blood clots when compared to similar pills made with other progestins.

Yaz, Yasmin and other drospirenone-containing birth control pills have been named in thousands of lawsuits in which plaintiffs allege they suffered serious, life-threatening side effects including blood clots, deep vein thrombosis, pulmonary embolism, strokes, gallbladder problems, and other serious complications. Most cases were consolidated into a multidistrict litigation (MDL No. 2100) currently pending before Judge David Herndon in the U.S. District Court for the Southern District of Illinois.

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