REAL-TIME DATA: YAZ COMPLICATIONS REPORTED TO FDA
The widely used birth control pill known as Yaz is available under many names - Yaz, Yasmin, Beyaz, Occella, Gianvi and by its active ingredient, drospirenone.
All forms of Yaz contain warnings for certain common clinical side effects, including headaches, fatigue, nausea or vomiting, breast pain, irritability and mood swings, menstrual irregularities, decreased libido or weight gain.
Since December 2011, the FDA has also required a warning that Yaz may cause blood clots, leading to deep vein thrombosis, stroke, pulmonary embolism or heart attacks.
However, a review of adverse event reports filed with the FDA, as listed below, shows women taking Yaz have experienced many different side effects not listed on the drug, from pancreatitis to blurred vision.
Most Common Side Effects Reported to the FDA
Since Yaz and Yasmin were launched in the United States, 9,186 women have filed FDA complaints for general pain side effects. This may include joint pain, stomach pain, reproductive organ pain or muscle pain.
The FDA has received 7,909 reports of women suffering non-specific injury while taking Yaz or Yasmin. Many of these include injuries related to blood clots or gallbladder disease.
Pulmonary embolism, which is a condition where blood clots block oxygen to the lungs causing serious damage, have been reported to the FDA for 5,741 women taking Yaz or Yasmin.
Deep vein thrombosis is a condition in which a blood clot blocks the flow of blood deep in the tissue of a lower extremity or the abdomen. So far, 5,262 patients have reported DVT while on Yaz or Yasmin.
4,749 women have reported feelings of anxiety while taking Yaz or Yasmin.
So far, the FDA has received 4,587 adverse event reports related to women suffering emotional distress while taking Yaz or Yasmin. This can include feelings of anxiety, depression or bipolar disorder.
3,981 patients taking Yaz or Yasmin have reported chronic cholecystitis, an ongoing inflammation of the gallbladder due to a blockage of the cystic duct. This can cause frequent abdominal pain.
Since 2002, the FDA has received 2,919 reports of women on Yaz or Yasmin suffering gallstones, a condition known as cholelithiasis.
2,865 women have reported a non-specific gallbladder disorder while taking Yaz or Yasmin birth control.
Among adverse event reports for the drugs Yaz and Yasmin, 2,340 patients have noted "general physical heath deterioration."
1,857 women have reported general abdominal pain while taking Yaz birth control. This may be a symptom of a more serious condition such as a deep vein thrombosis or gallbladder injury.
Since the launch of Yasmin, Yaz and Occella, 1,688 women have reported symptoms of severe nausea.
The FDA now requires that drug manufacturers submit regular reports of patient side effects, which is maintained on the Adverse Events Reporting System (AERS). DrugNews gathers this information on a regular basis to keep consumers informed of possible risks from drugs like Yaz.
So far, Bayer has paid almost $2 billion to women suffering Yaz side effects. If you have more questions about these complications, or would like to speak with a lawyer about a claim, contact DrugNews today.