Avandia Manufacturer Implements FDA Requirement to Strictly Control Patient Access

By February 10, 2011Dangerous Drugs

As a dangerous drug attorney, I have followed the news about the diabetes drug Avandia closely. Avandia (rosiglitazone) was once a very popular drug for treating Type II diabetes – but at least two studies showed that it actually elevated patients’ risk of heart problems and strokes. Worse, there’s evidence that Avandia’s manufacturer, GlaxoSmithKline, knew about the risks for several years before those studies, but tried to cover them up and even intimidate scientists who made negative conclusions about the drug. In September, European regulators took Avandia off the market altogether, and the FDA ordered a new, very strict warning label limiting who may take Avandia. That label has arrived, as MedPage Today reported Feb. 8, even as GlaxoSmithKline agreed to pay $250 million to settle Avandia injury and death claims.
The new warning label says Avandia may be prescribed only to two groups of patients. One is patients who are already taking it. Those patients should not stop taking it without bringing it up to their doctors. The other group is people who have not been able to control their diabetes with other drugs in the same class and have medical reasons to avoid Actos (pioglitazone). The new label also warns patients about the increased risk of heart attacks, heart failure and related conditions. GlaxoSmithKline is still working on another part of the September order, which asked it to have independent scientists analyze data from its RECORD study of Avandia, after observers raised concerns about bias in the company’s own analysis. And the company is still working on FDA-ordered measures to ensure that patients obey the warning label, which includes a requirement for patients to sign a statement that they understand the risks.
This may not be the total ban that some public health advocates wanted in the United States – but as a defective prescription drug lawyer, I believe this will go a long way toward ending unnecessary deaths, strokes and heart attacks caused by Avandia. Already, NPR reports that only about 100,000 Americans are taking Avandia, down from 600,000 in September and about 1 million in 2007. That was the year that Dr. Steven Nissen of the Cleveland Clinic performed a meta-analysis showing Avandia raised patients’ risk of heart attack by 43 percent. That’s especially troubling because diabetics are already at an increased risk of heart and circulatory problems. Just as troubling was Nissen’s allegation that GlaxoSmithKline tried to discourage him from publishing his results through deception. How many similar actions never made it into the press?


Even when drug companies try to stack the deck in their favor, the law still protects injured patients and their loved ones. At Carey, Danis & Lowe, we represent people around the United States who were seriously injured by taking a prescription or over-the-counter drug they thought they could trust. The FDA is supposed to keep track of drug safety, but sometimes the regulatory process fails – especially when drug makers intentionally deceive regulators and the public. When that happens, patients can be killed, sickened or injured through no fault of their own. Our pharmaceutical liability attorneys help victims recover damages for injuries like this, including compensation for any medical bills, lost income and permanent disability the drug caused.
If your family suffered a serious injury or illness because of a prescription drug that turned out to be unsafe, Carey, Danis & Lowe can help. To set up a free consultation, send us a message online or call 1-877-678-3400 toll-free.