The United States Food and Drug Administration has renewed its scrutiny into Yasmin, Yaz and other birth control pills with newer formulations, warning that these may increase the risk for blood clots.

The new investigation was ordered when a federal judge in Illinois who is overseeing a consolidation of Yaz cases unsealed on Dec. 5 several court documents that suggested Bayer may have withheld data from FDA about the blood clots risks of its drugs.

The documents stem from expert opinion gathered by personal injury lawyers suing Bayer AG, the manufacturer of Yasmin and Yaz, on behalf of patients who experienced blood clots after using the drug.

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives, including FDA reports of at least 50 deaths linked to the pills from 2004 to 2008. The first trials are scheduled for next month in federal court in Illinois and state court in Philadelphia.

According to one court document, Bayer drafted a white paper in 2004 to address “FDA concerns,” about clots with Yasmin. This paper did not include information found in an earlier draft that reported that blood clots associated with Yasmin use were significantly higher than those linked to three other oral contraceptives.

Continue reading Deaths Linked to Yasmin Birth Control Pills? →

Yasmin Side Effects: Blood Clots? Yasmin, Yaz and other birth control pills with newer formulations may increase the risk for blood clots, safety regulators in both the United States and Canada warned separately this week.

These oral contraceptives, which use a synthetic formulation of the female hormones drospirenone and ethinyl estradiol are now under the U.S. Food and Drug Administration’s renewed scrutiny, following research that suggests these pills are more likely to cause blood clots than older birth control drugs.

The FDA’s latest analysis on Yasmin side effects estimates that the risk of a blood clot with drospirenone-containing pills is 1.5-fold higher than contraceptives based on other hormones.

That translates into about 10 in 10,000 women on the newer drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives, the FDA said.

Continue reading Yasmin Side Effects: Does Yaz Cause Blood Clots? →