What Is a Black Box Warning and Does My Birth Control Have It?

The Food and Drug Administration (FDA) is the federal agency responsible for regulating pharmaceutical drugs in the United States. The FDA protects patients by ensuring that drugs are safe for use. In recent years, the FDA has required a number of drug makers to place “black box warnings” on their birth control pills. The move has left many patients wondering, “What is a black box warning and why was it used?”

What Is a Black Box Warning?

Under FDA rules, black box warnings are issued for drugs that may cause a patient to suffer serious injury or death. They are called “black box” warnings because a black box encases the warning in the prescription information for the drug. In response to evidence that oral contraceptives containing drospirenone and ethinyl estradiol carry a number of health risks, the FDA required the makers of these birth control pills to place black box warnings on their packaging. Popular birth control brands that carry a boxed warning include Yaz, Beyaz, Safyral, Gianvi, Loryna, Ocella, Syeda, Vestura, and Zarah.

What Does the Birth Control Black Box Warning Say?

According to the FDA, combination oral contraceptives may cause serious harm to women who smoke cigarettes. Blood clots, heart attack, stroke, and even death can occur. As a result, the FDA requires a black box warning for combination birth control pills. The black box warning provides:

  • Combination oral contraceptives increase the risk of cardiovascular side effects in women who smoke.
  • The risk of cardiovascular side effects increase with the number of cigarettes smoked and the age of the woman.
  • Women over the age of 35 who smoke shouldn’t take combination oral contraceptives.

In addition, various studies have linked drospirenone-containing oral contraceptives to the increased risk of blood clots. Blood clots can cause heart attack, stroke, deep vein thrombosis, loss of eyesight, pulmonary embolisms, and death in some cases. In 2012, the FDA issued a safety communication finding that women taking drospirenone-containing birth control pills may have a higher risk for developing blood clots than women taking other progestin-containing birth control pills. Consequently, the FDA required that prescription information for drospirenone-containing oral contraceptives contain warnings about these risks as well.

Lawsuits involving Drospirenone-Containing Birth Control Pills

Numerous women have complained to the FDA that taking drospirenone-containing oral contraceptives such as Yaz and Yasmin have caused blood clots, heart attack, stroke, deep vein thrombosis, vision loss, pulmonary embolisms, and gallbladder injuries. In the worst cases, women have died as a result of these complications. Consequently, thousands of lawsuits have been filed against the manufacturers of drospirenone-containing birth control pills.

Product Liability

Under product liability law, drug manufacturers and sellers generally have a duty to ensure that their products are safe for patients. Drugs that carry a design defect, manufacturing defect, or defective warnings may expose manufacturers to liability. Patients who are injured by a defective product may file a product liability suit against the manufacturer or seller in order to receive compensation. In the birth control pill lawsuits, plaintiffs have claimed that Yaz and other drospirenone birth control pills carried defective warnings because the manufacturers failed to warn patients about the risk of blood costs and other injuries. If plaintiffs prevail, they could be awarded damages for any lost wages, medical expenses, and pain and suffering that resulted from their injuries.

Wrongful Death

If a woman died as a result of taking drospirenone-containing oral contraceptives, her family may be able to file a wrongful death action against the manufacturer. Under wrongful death laws, surviving family members, including spouses and parents, may sue the person or entity responsible for their loved one’s death. In some states, domestic partners may pursue wrongful death claims as well.

Medical Malpractice

Some women have filed lawsuits against their doctors for medical malpractice. Under medical malpractice law, doctors and other healthcare provides can be held liable for providing services that fall below the standard of care practiced in the field. For example, a plaintiff may allege her doctor failed to warn her about the oral contraceptives’ safety risks or prescribed the birth control pills even though the woman is over the age of 35 and smokes cigarettes.