There are a variety of birth control pills available on the market today. While most are generally regarded as safe, birth control pills containing the ingredients drospirenone and ethinyl estradiol have been linked to serious medical complications. The Food and Drug Administration (FDA) deemed these pills dangerous enough to require that their packaging carry a boxed warning, the FDA’s strongest warning. This article will discuss the dangers associated with birth control pills containing drospirenone and ethinyl estradiol as well as a possible birth control recall.
What are drospirenone & ethinyl estradiol birth control pills?
Drospirenone and ethinyl estradiol are a combination of synthetic hormones designed to prevent pregnancy. These man-made hormones prevent ova (a woman’s eggs) from becoming fully developed. Unlike some other birth control pills, the drospirenone and ethinyl estradiol birth control pills are also used to treat acne in women at least 14 years of age as well as premenstrual syndrome (PMS).
What are the complications involved with drospirenone/ethinyl estradiol birth control pills?
Drospirenone and ethinyl estradiol birth control pills have been linked to serious complications, most of which involve blood clots. These blood clots can lead to stroke, heart attack, and even death. Serious complications can include:
- Pulmonary embolism – blood clots formed in the lungs that creates respiratory issues
- Deep vein thrombosis (DVT) – blood clots that usually form in the lower leg or thigh, resulting in pain and swelling
- Coronary thrombosis – blood clots in the arteries that supply blood to the heart, resulting in a possible heart attack
- Thrombotic stroke – blood clots in the brain that may lead to stroke
Has there been a birth control recall?
There hasn’t yet been a birth control recall for pills containing drospirenone and ethinyl estradiol. However, a birth control recall could occur in the future. This is because FDA studies have found that birth control pills containing drospirenone show as high as a three-fold increase in the risk of blood clots when compared to other birth control products. In addition, the FDA already requires drospirenone/ethinyl estradiol birth control pills to have a boxed warning, the strongest warning the FDA provides.
What is the difference between an FDA “boxed warning” and a recall?
A boxed warning, also known as a “black box warning,” is the most serious FDA warning for prescription drugs. The boxed warning is intended to alert consumers of serious adverse reactions a drug could have. Black box warnings are appropriate in the following situations:
- When adverse reactions outweigh the potential benefit from the drug
- When an adverse reaction can be prevented or limited by appropriate use and instructions
- When the FDA ensures the drug is safe but only with proper restrictions and instructions
Popular brands of drospirenone and ethinyl estradiol birth control pills include Yaz, Yasmin, Beyaz, Ocella, and Gianvi. All of these brands carry a boxed warning stating that the product should not be used by female smokers 35 years old and over because the combination of cigarettes and birth control pills can increase the likelihood of serious cardiovascular complications.
However, a boxed warning is not a recall. A recall is the removal of a product from the marketplace. Recalls are generally issued because the product is defective or potentially harmful. Manufacturers often voluntarily issue recalls in order to minimize the harm caused by their products. For example, a company may voluntarily take its product off the shelves if it discovers a potential defect, or if the FDA has raised concerns about the product’s safety. In rare occasions, the FDA will request a recall if a product is very dangerous and the manufacturer has failed to address the problem.
Do I still have a legal claim even if a birth control recall did not occur?
Many people incorrectly believe they can only file a lawsuit if the product that injured them was recalled. However, even if there was no recall, people injured by defective products can file a product liability claim. Under product liability law, manufacturers and sellers are liable for any injuries caused by defective or dangerous products they place in consumers’ hands. For example, a Yaz birth control user may sue Bayer, the company that manufactures Yaz, claiming that drospirenone caused her stroke.
Families of deceased drospirenone/ethinyl estradiol birth control pill users may also file suit on behalf of their loved ones. Close relatives, including spouses, parents, and offspring, may file a wrongful death lawsuit against drospirenone and ethinyl estradiol birth control companies to recover compensation. Individuals harmed by drospirenone and ethinyl estradiol birth control pills should consult with an experienced attorney to learn about their legal options.