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Yaz FDA Warnings and Recall

FDA Yaz warningsIn December 2011, the FDA convened a panel of experts to provide a recommendation regarding a possible Yaz recall.  Although the group voted against the recall by a slim margin, many doctors and watchdog groups believe that Yaz, Yasmin, and similar drugs are not safe enough to be on the market due to an increased risk of serious side effects compared to other birth control pills.  As a result of the danger, the Yasmin and Yaz product labels contain a black box warning, which is the most severe warning the FDA will issue.

Yasmin and Yaz FDA warnings

In lieu of a Yaz recall, the FDA has ordered Bayer, maker of Yaz and Yasmin, to provide doctors and patients with extensive safety information regarding the administration of birth control pills containing drospirenone, the active ingredient in Yaz, Yasmin, and several other recently developed birth control pills.

The Yaz FDA warning advises patients not to use these medications if they have any of the following contraindications.

Risk factors for Yaz and Yasmin side effects:

  • renal impairment (kidney problems)
  • adrenal insufficiency
  • undiagnosed abnormal uterine bleeding
  • breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • liver tumors, benign or malignant, or liver disease
  • a high risk of arterial or venous thrombotic diseases

Because blood clots are among the most serious side effects of Yaz, the warning label lists a set of particular risk factors for developing blood clots when taking Yaz or Yasmin.

Risk factors for Yaz and Yasmin blood clots

  • smoking, if over age 35
  • deep vein thrombosis or pulmonary embolism, now or in the past
  • cerebrovascular disease
  • coronary artery disease
  • heart disease known to produce clots (including bacterial infection or heart murmur)
  • inherited or acquired hypercoagulopathies (blood clotting disease)
  • uncontrolled hypertension (high blood pressure)
  • diabetes mellitus with vascular disease
  • headaches with focal neurological symptoms
  • migraine headaches, if over age 35

The following warnings apply to women who are taking Yaz, Yasmin, or Ocella:

  • discontinue use of the pill if a blood clotting event occurs
  • if jaundice occurs, discontinue the pill and seek medical treatment
  • may cause hyperkalemia
  • may cause liver cancer
  • may increase blood pressure
  • may cause gallbladder disease
  • may cause changes in glucose tolerance
  • may cause headache
  • may cause menstrual bleeding irregularities
  • may cause depression
  • may interfere with some laboratory tests
  • women taking these medications should have a yearly checkup to monitor the potential side effects of the pill

Yaz receives “black box” warning

A boxed warning, or black box warning, is the most stringent FDA warning for a prescription medication.  It is required to be displayed prominently in all informational materials about the drugs and is designed to call attention to a particularly dangerous set of side effects.  Although the FDA has decided not to issue a general Yasmin and Yaz recall, the agency does require these drugs to carry the following boxed warning:

“Do not use Yaz if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.”

While women who smoke cigarettes and are over 35 are at the highest risk of developing blood clots, all women who take oral contraceptives are at an increased risk and evidence suggests that Yaz and Yasmin blood clots are more likely than those from other contraceptives.

Yaz and Yasmin can cause the following types of blood clots:

  • pulmonary embolism, when a blood clot blocks the lungs, causing difficulty breathing, pain, and potentially death
  • deep vein thrombosis, or DVT, when a clot causes pain and swelling, usually in the legs
  • cerebral embolism, when a clot (often from DVT) travels to the brain causing stroke
  • cerebral thrombosis, a blood clot in the brain resulting in the most common type of stroke
  • retinal thrombosis, when a clot forms in the eye, causing loss of vision
  • coronary thrombosis, when a clot forms in an artery that supplies blood to the heart, resulting in a myocardial infarction, or heart attack

Injured Yaz users file lawsuits against Bayer

In the absence of a Yaz recall, many women continue to take the birth control pills unaware of the risks, as the FDA warning on the product was limited to a brief change in text that mentioned an increased risk of blood clots for all birth control pill users. Those who develop serious side effects from Yaz or Yasmin, and the families of women who suffered fatal complications often have grounds for filing a claim based on inadequate warnings, product defect, negligence, and breach of warranty.  There are currently over 11,000 Yaz lawsuits pending against Bayer involving blood clot related injuries and gallbladder disease, and the company has reportedly settled 5,700 blood clot injury claims and 9,000 gallbladder injury lawsuits for a total of over $1 billion.