The public is constantly being bombarded by new drugs, many of which may have the potential to cause us serious harm. Unfortunately, some drug manufacturing companies intentionally conceal the most serious side effects associated with their medications in order to ensure FDA approval. This also puts consumers unknowingly and unwillingly at risk for developing serious illnesses and health conditions that may even prove to be fatal. Some drugs currently on the market are so dangerous that their risks may actually outweigh their benefits. For example, Yasmin, the popular oral contraceptive pill manufactured by Bayer Healthcare Inc., promises consumers effective pregnancy prevention, as well as some off-label benefits such as moderate acne treatment and treatment of symptoms of premenstrual dysphoric disorder. Unfortunately, the drug has also been associated with severe and potentially fatal health conditions, including increased risk of heart attack.
Yasmin was first approved by the FDA in 2001 and has since become one of the most popular forms of oral contraception. Since the drug’s introduction to the market, Yasmin has been under heavy scrutiny for its connection to life-threatening health problems. According to a 2009 study published in the British Medical Journal, individuals taking Yasmin and similar oral contraceptives are more than six times as likely to develop blood clots. Blood clots are extremely dangerous because if they break free, they can travel through the blood stream and block the blood supply to vital organs. If the clot travels to the brain it can cause a stroke; if it blocks blood flow to the heart it can cause a heart attack.
A heart attack occurs when the blood flow to a section of the heart is blocked, cutting of the organ’s essential blood supply. The source of the blockage is most often a blood clot that has wedged itself in a coronary artery leading to the heart. If the blood flow isn’t restored quickly, the affected section of the heart will become damaged from lack of oxygen and begin to die. The most common symptoms of a heart attack are chest pain or discomfort, shortness of breath, and discomfort in the back, neck, stomach, jaw, or one or both arms. Other symptoms of a heart attack include dizziness, shortness of breath, fainting, vomiting, nausea, and a lightheaded feeling. When a large amount of heart muscle dies, the ability of the heart to pump blood to the rest of the body is inhibited, resulting in major organ failure.
The main source of Yasmin’s danger is believed to be one of the drug’s active ingredients, called drospirenone. Yasmin is one of a small group of oral contraceptives called “fourth generation” combination birth control pills, which contain both estrogen and drospirenone, a newer form of synthetic progestin hormone. According to the FDA, the use of drospirenone, an ingredient unique to Bayer products and not used in any other birth control pills in the U.S., may result in major heart and health problems, including blood clots, stroke and heart attack. The harmful aspect of drospirenone is that it can increase the level of potassium in the blood which can lead to hyperkalemia, a condition associated with kidney failure and cardiac arrest.
In 2008, the FDA sent Bayer a warning letter accusing the company of inaccurate portrayal of Yasmin in television advertisements. In these commercials, Bayer implied that Yasmin was superior to other combination oral contraceptives while simultaneously minimizing imperative risk information. In 2009, the FDA composed another warning letter to Bayer criticizing the company for using a flawed method during the clinical testing of their drug, Yasmin. According to the FDA, the testing method of the German manufacturing facility was averaging test results instead of reporting results for individual batches. At least eight of these inadequately tested batches had already been shipped to the United States at the time that this letter was composed.
Despite the potential for Yasmin to cause heart attack, stroke, pulmonary embolism and other life-threatening conditions, the drug remains on the market today. In fact, Yasmin has been heavily marketed to women as a safe and effective medication, and it is estimated that one hundred million women worldwide use oral contraceptives like Yasmin. Unfortunately, many people may be unaware of the dangers associated with this medication because of the inadequate warning information provided by Bayer and misleading advertising campaigns. Victims of serious injury resulting from the use of Yasmin are not at fault and should contact a Yasmin attorney to discuss how a lawsuit may benefit them. The severe adverse side effects associated with Yasmin have already prompted multiple lawsuits against Bayer and many additional cases of Yasmin-related injury are currently being investigated. If you or a loved one has suffered from a major illness or injury related to the use of Yasmin, an experienced Yasmin lawyer can help you collect the compensation you deserve.
