Overview: The National Drugs Safety Agency (ANSM), the health regulatory agency in France, is looking to reduce the use of third and fourth generation birth control pills such as Yaz and Yasmin. The inquiry into the matter is based on reports that the birth control pills can cause blood clots. France has already announced that they will no longer reimburse such oral contraceptives. Meanwhile in the United States, thousands of lawsuits have been filed over the alleged side effects of Yaz and Yasmin.
- French regulatory agency ANSM is looking to reduce the amount of prescriptions for 3rd and 4th generation birth control pills such as Yaz and Yasmin
- The move was at least partially based on a 25 year old woman who filed a lawsuit after being handicapped by a stroke allegedly caused by Yaz/Yasmin
- Last year Bayer spent $750 million to settle 3,500 lawsuits alleging deep vein thrombosis and pulmonary embolism
Product: Yaz®, Yasmin® (Drospirenone and Ethinyl Estradiol)
Manufacturer: Bayer AG
Side Effects & Complications
- Blood Clots
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT)
- Gallbladder Damage
- Heart Attacks
Earlier this month, the ANSM began scheduling talks with medical associations to discuss the use of third and fourth generation birth control pills such as Yaz and Yasmin; these oral contraceptives contain a synthetic hormone called drospirenone, which has been associated with an increased risk of blood clots. The agency is inquiring about whether or not doctors are overprescribing the pills. ANSM Director General Dominique Maraninchi said “We are looking for a massive reduction in the consumption of these pills,”
The ANSM move is at least partially based on the lawsuit filed by a woman who was left handicapped after suffering a stroke, allegedly due to Bayer’s birth control pill. Last year Bayer has spent $750 million to settle about 3,500 lawsuits alleging Yaz caused blood clots.
Yaz, Yasmin Linked to Blood Clots
In April, the U.S. Food and Drug Administration (FDA) updated the label on Yaz, Yasmin and other birth control pills containing drospirenone. The new label warns that the risk may be three times as high in women taking these types of oral contraceptives. A recent study funded by the agency also found that use of birth control pills containing drospirenone was associated with a 77 percent increase in venous thromboembolic events and a two-fold increased risk of arterial thromboembolic events.