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Since the news broke about Avandia’s link to serious health complications, many patients have considered filing Avandia lawsuits.
If you’re thinking about an Avandia lawsuit, contact the unsafe drug litigation attorneys at Anapol Schartz for a free evaluation of your case.
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When the bad news about Avandia’s safety problems emerged in May of 2007, regulators and doctors may have glossed over one of the most insidious potential threats of the drug. The safety concerns stem from a study published in the New England Journal of Medicine, which found that patients taking Avandia were 43 percent more likely to have heart attacks (myocardial infarction) and 64 percent more likely to have heart-related deaths. In response, the FDA required a “black box” warning on Avandia’s labels, the most serious patient warning in the agency’s arsenal. That warning has been strengthened twice so far, but continues to contain “medicalese” that warns of an increased risk of “myocardial ischemic events.” In plain English, that means health events caused by restricted blood flow to and around the heart. And one of the deadliest cardiac events that has been connected with Avandia use is a rare but serious disease called primary pulmonary hypertension.
In primary pulmonary hypertension (PPH), the patient’s blood pressure skyrockets, but only in the artery that carries blood from the heart directly to the lungs. This puts extra strain on the heart, which must work harder to pump blood through the lungs. For the patient, the effect is unexplained fatigue; then trouble breathing, dizziness and fainting; and as the disease progresses farther, blue lips and skin, swelling in the extremities and chest pain. Doctors don’t know what causes PPH, and there is no cure. Treatment is generally a mixture of surgery and blood-pressure drugs, but very serious cases may require lung or heart-lung transplants. Left untreated, PPH causes fatal heart failure. The median survival rate for PPH patients is three years from diagnosis; very serious cases may require lung or heart and lung transplants.
PPH is rare and difficult to identify; medical authorities estimate that 300 to 1,000 Americans are diagnosed with the disease each year. However, chemical exposure is a known risk factor, and it is well-documented that certain drugs, especially the discredited diet drug fen-phen, can cause PPH. The news that Avandia is also associated with an increased risk of this life-threatening, incurable condition means that thousands of diabetics are at risk for very serious health problems. Ironically, a drug that was supposed -- and prescribed -- to help diabetics control their risk of heart problems may turn out to have caused those problems for thousands of patients.
Even worse, evidence is growing that Avandia’s manufacturer, GlaxoSmithKline, knew for years that its drug could cause heart problems, but covered up the information in the name of profit. Congressional hearings on Avandia have revealed that the drug’s manufacturer threatened to sue a diabetes expert, Dr. John Buse, after his remarks on the drug’s association with heart problems caused their stock to slide. That was 1999, the first year Avandia was available in the United States; Dr. Buse sent more information to the FDA in 2000, but the agency took no action until 2007. Meanwhile, Avandia enjoyed about $3 billion a year in worldwide sales, and doctors unwittingly prescribed the unsafe drug to at least 1 million Americans.
If you or someone you care about has primary pulmonary hypertension, you know it’s no picnic. Patients and their families are often physically weakened, financially strained by all the necessary medical care, and worried about the future. If you suspect that your PPH may have been caused by using Avandia, you have the right to be angry -- and you deserve answers. More and more diabetes and heart disease patients who were affected by Avandia are considering Avandia legal claims, to help them recover high medical costs, punish drug executives who put profits over public health, and convince our government to take this dangerous drug off the market.
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