September 26,2011: The U.S. Food & Drug Administration (FDA) issued an updated Drug Safety Communication informing the public that it “remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.” The FDA is advising patients to speak to their healthcare professional about the risk of blood clots before deciding which birth-control pill to use. This alert was updated on October 27, 2011 in a FDA Safety Medwatch If you have used Yaz/Yasmin or Ocella and have experienced any of these side effects, we urge you to contact us today at1-800-YOURLAWYER (1-800-968-7529).
FDA Approved Oral Contraceptives Containing Drospirenone
The Yaz/Yasmin/Ocella group of birth control drugs, an oral contraceptive, contains progestin drospirenone or drsp. Drsp is a diuretic which may elevate the levels of potassium in the blood stream. Unsafe levels of potassium in the blood stream, also known as hyperkalemia, can disrupt heart rhythms and slow the flow of blood throughout the body. Drospirenone is also a diuretic and if the body is dehydrated this can lead to blood clotting. Symptoms of hyperkalemia include nausea, fatigue, muscle weakness or tingling sensations.
Drospirenone and/or elevated potassium side effects may include pulmonary embolisms, deep vein thrombosis or DVT, blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and even death. If you experienced any of these side effects while taking Yaz, Yasmin, or Ocella, please contact us right away for a free case evaluation.
New reports highlight problems with Yaz Yasmin Ocella Side Effects
Swiss media is reporting that nearly 200 women have died while taking Yaz and Yasmin, Bayer’s blockbuster contraceptives. 190 women have died according to BNET, and Bayer’s shareholders are furious with how Bayer marketed the drugs. At the annual meeting on April 29, a shareholder motion is expected however, said BNET, but the motion will likely not pass. Still, shareholders are hoping that the motion will bring attention to Bayer’s marketing of the contraceptive medication problems.
Over 6,850 lawsuits have been filed since February of this year. These lawsuits claim that the birth control pills led to potentially lethal blood clots and gall bladder damage and failure, said BNET, citing page 242 of Bayer’s annual report. More lawsuits are expected. While the total number of deaths cited in the lawsuits is not known, a German-language report on Swiss Television claimed that a search of the U.S. Food and Drug Administration (FDA) adverse event database discovered 140 fatalities linked to Yasmin and 50 to Yaz, said BNET. Because the database includes unconfirmed reports, said BNET, the actual number of fatalities linked to Yaz and Yasmin might be lower; however, release of those numbers and the number of lawsuits filed will create challenges for the drug maker, especially when it attempts to defend its birth control pills as being safer than older birth controlmedications.
Through this Bayer has been touting two studies it had commissioned, citing these studies as proof that their birth control drugs are safe. This contradicts other uncommissioned studies that have found the contraceptives Yaz and Yasmin increase the risk of blood clots more than other types of birth control pills.
Yaz Yasmin Side Effects May Lead To Stroke
The Yaz, Yasmin & Ocella lawsuit deals with the birth control pills’ nasty side effects, which may
be putting millions of young women at risk. Side effects of Yasmin and Yaz may include stroke, heart attack and even death. Bayer USA, the maker of Yaz and Yasmin birth control pills, has already come under fire from the Food & Drug Administration (FDA) for running TV commercials that minimize the possible health consequences and side effects of Yazand Yasmin.
In the summer of 2009 several lawsuits were filed by women who claimed Yaz birth control made them sick. They allege Bayer overstated the benefits of the drug and failed to warn that it could put women at risk of serious injury from Yaz birth control side effects. It is expected that many such Yaz class action lawsuits will be filed in the future.
Our Yasmin and Yaz Side Effects lawyers are offering free case evaluations to victims of this drug. If you or someone you love suffered from Yasmin or Yaz birth control side effects, you may be eligible for compensation for medical bills, lost wages and pain and suffering. We urge you to contact our Yaz lawyers right away to protect your legal rights.
Ocella/Yaz/Yasmin Side Effects
Yaz is one of the best-selling oral contraception pills in the U.S., with 2007 sales of $616 million. Yaz is a combination birth control pill that contains estrogen and progestin. Yaz is considered a low-dose pill, in that it contains .035 milligrams or less of estrogen.
Yaz received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in October 2006. Finally, in January 2007, Yaz was approved to treat moderate acne in women who desire an oral contraceptive for birth control.
Evidence is growing that Yaz carries serious health risks. Yaz contains a synthetic type of progestin called drospirenone. According to the FDA, drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients. This condition may result in potentially serious heart and health problems.
Because of this risk, women with conditions that predispose them to hyperkalemia (such as renal insufficiency, hepatic dysfunction and adrenal insufficiency) should not take it as they may be in danger from the side effects of Yaz. Women taking Yaz must also be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.
In order for Yaz users to avoid high potassium levels, blood tests should be drawn every few months. Most women who take Yaz don’t know about taking these blood tests because the instructions to take the tests are given in a small package insert with the birth control – something few people ever read.
Women involved in Yaz lawsuits have claimed that they suffered from a variety of serious ailments. These include deep vein thrombosis, pulmonary embolism, and stroke. Yaz has also allegedly been associated with heart attacks and deaths in young women.
Finally, the FDA’s Adverse Event Reporting System (AERS) lists a variety of other side effects of Yaz reported by users. These include severe allergic reactions, rash, hives, itching, difficulty breathing, chest tightening, fainting, irregular heartbeat, liver problems, unusual or severe vaginal bleeding, unusual tiredness or weakness, vaginal irritation or discharge, and vision changes.
Bayer Yaz Gastrointestinal Side Effects and Risks
Gastrointestinal problems are another possible Yaz side effect that can make a young woman’s life miserable. It is estimated that approximately 10 percent of Yaz users will suffer some sort of digestive issue while taking this contraceptive. These problems can include digestive tract inflammation and gastroenteritis that is accompanied by nausea, vomiting, diarrhea and abdominal pain. Some of the milder Yaz gastrointestinal problems frequently occur only during the first several months of taking the pills.
Bayer Yaz Ads Downplay Yasmin Side Effects and Risks
Despite the known side effects associated with Yaz, Bayer has downplayed risks when marketing the drug. In October 2008, the FDA cited two Yaz commercials for deceptive claims. In a warning letter, the FDA faulted Bayer for overstating the benefits of Yaz. The FDA also criticized the ads for containing fast-moving images and background music that might be distracting to viewers. These elements were aired while information about potential Yasmin side effects – including potentially life-threatening blood clots – was described. The FDA warning letter said the television commercials minimized the risks posed by Yaz.
Bayer quickly agreed to stop running the offending Yaz ads. As a part of an agreement with the FDA and Yaz attorney generals in 27 states, Bayer began running a new ad campaign in February 2009 to correct information conveyed by the deceptive Yaz commercials. The Yaz lawsuits settlement also required that Bayer submit all Yaz ads for federal screening before they appear.
While the FDA has required drug makers to pull deceptive advertising before, it is highly unusual to require companies to run corrective spots, such as the one introduced by Bayer for Yaz. Clearly, the agency believed that the popularity of the Yaz brand and the misleading ads had demanded this extraordinary remedy.
Legal Help for Victims of the Side Effects of Yaz – Yaz Lawyers
If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with a Yaz attorney.