More Evidence Emerges of Increased Risk of Death and Disability From Avandia

By July 8, 2010Dangerous Drugs

Diabetics should take note of two newly published studies that confirm existing evidence that the diabetes drug Avandia (rosiglitazone) increases the risk of heart attacks as well as heart failure. As a defective drug injury attorney, I’ve been closely following the news about Avandia this year. In February, the disturbing findings of the Senate Finance Committee that GlaxoSmithKline, Avandia’s manufacturer, made claims it knew were misleading about the drug’s safety. In April, the FDA considered ending a study of Avandia early because it was unethical to expose patients to a 64% greater chance that they could have a heart attack associated with the drug. Now, the Consumer Reports Insights column in the Washington Post is advising diabetics to opt for the older diabetes medicine metformin over Avandia, because two more studies have just shown that Avandia increases the risk of heart attack, stroke, heart failure and death.
Avandia already carries a black box warning, the FDA’s strongest warning, that lets patients know the drug has been associated with heart failure. But in light of the two newly published studies, FDA regulators are questioning whether Avandia should be pulled off the market entirely because of its association with heart attacks. In one of the studies, published in the Archives of Internal Medicine, Dr. Steven Nissen of the Cleveland Clinic added 14 more studies to the 42 on which he performed a meta-analysis. This expanded and updated analysis confirmed his 2007 finding that taking Avandia increases the risk of heart attack. The Journal of the American Medical Association published another study, by the FDA’s David Graham and others, that found that taking Avandia increased the risk of stroke, heart failure and death. Graham and his colleagues’ study was based on their analysis of more than 227,000 Medicare records for patients taking Avandia or Actos (another diabetes drug).
From my perspective as a dangerous prescription drug injury lawyer, it’s worrisome that so many patients’ lives and health remain at risk while GlaxoSmithKline continues to deny what many studies have found. The FDA plans to consider Avandia’s safety in a mid-July advisory committee meeting, and the agency has noted its concerns about the drug for several years now. It’s unclear why FDA officials have not taken action against Avandia already. Internal FDA reports released by the Senate Finance Committee suggest that 500 heart attacks and 300 cases of heart failure could be prevented every month if Avandia patients took Actos instead, and some observers suspect that GlaxoSmithKline had declined to inform the public of these risks, even though the company had known of them for years.
Knowing how many things diabetics have to manage in their lives to stay alive and healthy, it’s hard to imagine that a drug manufacturer would choose to put patients’ lives at greater risk by withholding or denying information about a drug’s safety. But that may be what is happening here — and if so, it’s illegal as well as bad ethics. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don’t, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the physical, emotional and financial harm that results. Diabetes already carries an increased risk of heart and blood vessel disease, so it seems unlikely that patients and their medical caregivers would knowingly choose a drug that seriously increases their risks of heart attack and heart failure.


For patients who do suffer these dangerous side effects, there is legal recourse. Patients who suffer injuries because of a dangerous prescription drug can require the drug manufacturers to pay for medical expenses, lost wages, permanent injuries, pain and suffering and other damages related to the injuries that the drugs caused. If you have been hurt by a dangerous prescription drug, please call a knowledgeable pharmaceutical liability lawyer who can advise you of your rights. The legal specialists at Carey, Danis & Lowe offer free consultations for patients and families in this situation. Please call us at 1-877-678-3400 or contact us through our website.