Gianvi, the generic version of Bayer Pharmaceuticals’ controversial birth control pill Yaz, has recently been linked to a number of potentially life-threatening side effects including heart attacks, strokes, blood clots, pulmonary embolisms, abnormal heart rhythms, gallbladder injuries, pancreatitis, and death. Both Yaz and Gianvi contain a newly-created synthetic hormone known as drospirenone, the active ingredient thought to be responsible for the drugs’ adverse health risks. Yaz and generic Yaz users are advised to weigh the potential risks versus benefits of taking these medications with their doctors carefully.
Yaz / Yasmin Lawsuit Update 7/31/12: The number of lawsuits filed against pharmaceutical giant Bayer on behalf of women allegedly injured by Yaz and Yasmin continues to grow by leaps and bounds around the country, as the federal multidistrict litigation (MDL) for the cases recently surpassed asbestos as the largest in the nation. All of the complaints involve similar allegations which state that Bayer knew – or should have known – about the health risks involved with its blockbuster birth control pills, but that it failed to inform the public and medical communities about this risk.
Yaz Lawsuit Update 6/18/12: Last month, a former Yaz user filed a lawsuit against pharmaceutical giant Bayer after she allegedly suffered blood clots leading to a life-threatening pulmonary embolism (PE) event. The plaintiff claims she began using Yaz in November 2006 and subsequently developed blood clots from the drug leading to the PE in December 2009.
Yaz Lawsuit Update 5/2/12: For the third time this year, deadlines for lawsuits over side effects caused by Bayer’s controversial birth control pills Yaz and Yasmin have been extended another 90 days. The move, which was ordered by Chief Judge David R. Herndon of the U.S. District Court for the Southern District of Illinois, allows settlement negotiations to continue between Bayer and plaintiff lawyers for the next three months.
Yaz Blood Clot Lawsuit Update 4/13/12: Pharmaceutical giant Bayer will pay at least $110 million to settle approximately 500 lawsuits over claims that its controversial line of Yasmin birth control products cause blood clots. Officials of Germany’s largest drugmaker reportedly agreed to pay an average of about $220,000 a case to resolve the complaints, people familiar with the agreements said.
Generic Yaz Blood Clot Update 4/10/12: Birth control products containing the synthetic hormone drospirenone have been linked to an increased risk for blood clots, according to a warning issued today by the U.S. Food & Drug Administration (FDA). In response to these findings, the FDA has required that all drospirenone-containing contraceptives carry warnings which state that several studies have found as much as a three-fold increased risk of blood clots associated with drospirenone when compared to levonorgestrel, a different hormone found in many older forms of birth control.
What’s the Problem with Generic Yaz?
Manufactured and marketed by Teva Pharmaceuticals, Gianvi (drospirenone and ethyl estradiol) is a generic form of the oral contraceptive Yaz. Gianvi was approved by the U.S. Food & Drug Administration (FDA) in 2010 as a combination oral contraceptive (COC) regimen. COCs like Gianvi are chemically designed to work by changing the cervical mucus to make conditions difficult for the sperm to enter the uterus, thus significantly reducing the likelihood of implantation. Unfortunately, despite its relative effectiveness as a birth control product, generic Yaz contains drospirenone, a controversial synthetic hormone that has been increasingly linked to large number of serious side effects.
Generic Yaz Blood Clots
Two recent studies that evaluated the risk of blood clots in women who took drospirenone-containing birth control pills found that there is a two to three times greater risk of developing the condition compared to women who took contraceptives containing levonegestrel, a different hormone found in many older forms of birth control. The FDA is currently evaluating the results of the studies in an attempt to determine drospirenone’s role in causing blood clots. Signs and symptoms of a generic Yaz-induced blood clot in the arms or legs (deep vein thrombosis) may include:
- swelling or pain in the arms/legs
- redness or discoloration
- arms/legs feeling warm
Symptoms of a blood clot in the lungs (pulmonary embolism) may include:
- chest pain (most common)
- dizziness, lightheadedness or fainting (second most common)
- shortness of breath or difficulty breathing
- chest pain
- parts of the body turn blue (i.e. lips, skin)
- coughing up blood
- increased heart rate
- low blood pressure
Generic Yaz Stroke
Stroke-causing blood clots have been found to occur due to an abnormal increase of potassium in the body. Increased potassium levels have the potential to seriously thicken the blood. The drospirenone contained in generic Yaz increases the amount of potassium in the body, causing the blood to thicken and increasing the chance of a stroke. Signs and symptoms of a generic Yaz-induced stroke may include:
- numbness on one side of the body
- loss of vision / problems with vision
- change in alertness
- sudden intense headache
Generic Yaz Pancreatitis
Pancreatitis is an inflammatory condition that occurs when pancreatic digestive enzymes become active within the pancreas and attack the gland itself. The disease can be acute — appearing suddenly and lasting for just a few days — or it can be chronic, developing gradually and persisting over a prolonged period of time. Both varieties of the disease may be characterized by one or more of the following symptoms:
- upper abdominal pain
- abdominal pain that radiates to your back
- abdominal pain that feels worse after eating
- tenderness when touching the abdomen
- losing weight without trying
- oily, smelly stools (steatorrhea)
Moderate cases of pancreatitis may improve on their own with simple dietary changes, but more severe cases may require emergency medical intervention to avoid life-threatening complications. Chronic pancreatitis is usually treated with lifestyle changes and enzyme supplements to improve digestion, and occasionally with surgery.