Birth Control Drugs Yaz®, Yasmine®, and Ocella® Carry Black-Box FDA Warnings

Not all birth control drugs are created equal. While the main focus of these drugs is the prevention of pregnancy, altering hormone levels in women can have additional benefits, such as acne control and preventing mood swings. However, some of these medications can also have dangerous side effects, and may even result in the early deaths of patients.

The medications Yaz, Yasmin, and Ocella are different from most birth control pills due to their active ingredient, drospirenone. Drospirenone is a synthetic progesterone that contains synthetic estrogen and lowers testosterone levels. It has 24 active pills and four inactive pills per month, unlike most birth control pills that have seven inactive pills per month. Women across a range of childbearing ages can be prescribed drospirenone, but Yaz’s marketing claims of controlling premenstrual dysphoric disorder (PMDD) and hormone-induced acne have make the drug especially appealing to younger women.

FDA Issues Highest Warning for Yaz Due to Blood Clot Risks

After a study by the U.S. Food and Drug Administration (FDA) revealed a 75 percent increased risk of blood clots in patients taking drospirenone birth control pills, the agency added a black-box warning to all Yaz and Yasmin birth control pill labels warning women of the potential for blood clotting and heart-related side effects. Women are also warned against taking Yaz if they have ever had blood clots in their eyes, legs, or lungs, have suffered endometriosis, have a history of uterine growths, or have abnormal menstrual periods or vaginal bleeding. Patients who have had fibrocystic breast disease, a history of lumps in the breast or abnormal mammograms, or a family history of breast cancer should likewise avoid drospirenone medications.

Complications of Yaz may be worse in some women who take the medication along with certain foods and other drugs. The effects of the pills could be altered. Women who are taking certain blood pressure medications, antibiotics, blood thinners (including heparin), diuretics, St. John’s wort, vitamin C supplements, or non-steroidal anti-inflammatory medications (such as ibuprofen) should seek an alternate form of birth control.

Along with the bleeding complications of Yaz, additional side effects may occur in the weeks or months after taking drospirenone, including:

  • Moderate to severe headaches (including migraine headaches)
  • Vaginal yeast infections or unusual discharge
  • Irregular (non-menstrual) vaginal bleeding
  • Severe uterine and stomach cramps
  • Hair loss
  • Weight gain
  • Acne
  • Decreased sexual desire
  • Dark spots or skin discoloration on the face
  • Elevated blood sugar that can contribute to early-onset diabetes
  • High blood pressure (hypertension)
  • Upper respiratory infections (flulike symptoms common cold)
  • Allergic reactions (such as hives, itching or watering of the eyes, swelling of the lips and tongue, or difficulty breathing)
  • Inability to wear contact lenses without irritation
  • Breast discharge or sudden presence of breast lumps
  • Numbness or tingling in the arms and legs
  • Gastric distress and inflammatory bowel disease (IBD)
  • Elevated potassium (hyperkalemia) that requires close monitoring of serum potassium levels

Bayer Pays Over $1 Billion to Settle Yaz Claims

As of 2014, drug manufacturer Bayer has settled over 8,000 cases of bleeding and clotting injuries caused by Yaz and Yasmin. Countless victims have still not come forward, and the company has already spent $1.5 billion to compensate women who have suffered strokes, heart attacks, and other medical conditions as a result of taking drospirenone birth control pills.

Not only have victims suffered injuries that could have lifelong effects, many plaintiffs have accused Bayer of downplaying or ignoring the bleeding dangers of Yaz and Yasmin. Some say that the company made false or misleading marketing claims in order to get more women to request the drug from their doctors instead of opting for safer methods of birth control. If you were injured as a result of taking Ocella, Yasmin, or Yaz, the McGartland Law Firm can help—and we do not collect any legal fees unless we win your case. Contact us today using our online contact form or call the number on this page to tell us your story.