Toronto – Health Canada has asked Pharmaceutical giant Bayer to revise labels on two popular birth control pills (YAZ and Yasmin) after concluding that use of these pills is linked to higher rates of blood clots than had been noted in other birth control pills. This revision occurs as Yasmin and YAZ are about to be scrutinized by the U.S. Food and Drug Administration (FDA) because of recent studies suggesting higher risks of blood clots in patients using these newer pills.
Bayer’s birth control pills, sold as Yasmin and YAZ, were heavily marketed as having fewer side effects than the older brands, as well as their ability to clear up acne and other hormonal issues.
After British medical journal BMJ published studies that raised safety concerns about birth control formulations containing drospirenone, Health Canada began a review. Yasmin and YAZ are the only oral contraceptives sold in Canada, which contain drospirenone. Drospirenone is closely related to the diuretic or water pill, which causes the body to retain potassium. Increased potassium levels can result in formulation of blood clots and lead to strokes and pulmonary embolism. Other side effects have been reported such as depression, heart attacks, kidney damage, liver damage, etc.
Last week, Health Canada issued a statement that its review of safety data for the drugs suggests women using these pills may be at a 1.5 to 3 fold increased risk of experiencing a blood clot as compared to women using other birth control pills.
Blood clots are a rare but well-known side effect associated with all birth control pills for many years. The risks of blood clots increase with the age of the patient, as well as if the patient is a smoker. Although blood clots can be treated when detected, untreated clots can result in the loss of a limb, a sudden heart attack or stroke. Clots that break free and travel to the heart or lung are fatal.
Health Canada did not urge women to stop using Yasmin or YAZ, saying that women and their physicians should discuss the risks and benefits of drospirenone-containing oral contraceptives and the individual’s risk of developing blood clots.
The U.S. regulator explained that figure in terms of cases per 10,000 women, suggesting they would expect about 10 blood clots in women taking contraceptives containing drospirenone, compared to 6 in 10,000 cases among women on different birth control pills.
Class action lawsuits have been filed in Canada and the United States by women who say they have experienced serious health problems following Yasmin or YAZ use.