Drug Maker, Roche, Ceases New Type 2 Diabetes Drug Testing Over Safety Risks

roche_diabetes_drugsDrug maker, Roche, just announced it has stopped development of a diabetes drug that is in the same class as the Type 2 diabetes drugs Actos and Avandia.

The move, according to The New York Times, could raise safety concerns about the entire class of Type 2 diabetes medications. The safety monitoring committee, wrote the Times, recommended that the late-stage clinical trial be halted over what it described as “safety signals and lack of efficacy” surrounding the drug, aleglitazar. Roche has since halted all studies of the drug.

“We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with Type 2 diabetes who are at risk of cardiovascular disease,” Dr. Hal Barron, the chief medical officer, said in a statement, according to the Times. In the trial, aleglitazar was associated with increased fractures, kidney problems, and heart failure.

Aleglitazar, Avandia, and Actos all belong to the drug class thiazolidinediones. Drugs in this class lower blood sugar by decreasing insulin resistance. Since November 2007, Avandia’s (rosiglitazone) U.S. label has included a black box warning detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increased risk of developing cardiovascular disease. Since 2007, more evidence of Avandia’s heart risks has accumulated and thousands of lawsuits have been brought against GlaxoSmithKline over the blockbuster drug. In 2010, the FDA placed severe restrictions on sales of Avandia after determining its heart risks outweighed its benefits.

Meanwhile, a vote at the conclusion of a recent two-day meeting of United States health advisors ended with a recommendation to ease current market restrictions on Avandia. The U.S. Food and Drug Administration (FDA) advisory committee was split, according to Reuters. The FDA will consider the vote prior to making a final decision on how Avandia can be used.

Actos (pioglitazone) has been associated with a growing number of adverse side effects based on a variety of respected studies. New research discussed ocular complications, injuries, and adverse reactions to the eyes linked to Actos use and some experts are concerned that Actos presents an increased risk of developing cataracts. Diabetic macular edema is an Actos side effect that can develop following surgery, though the condition can occur in the absence of such surgery.

In June 2011, the FDA warned that taking Actos for more than a year could significantly increase the risk of developing bladder cancer and the safety label on Actos was updated to address this risk. Other research also supports the link between Actos and bladder cancer. For example, last May, a study published in the British Medical Journal revealed that Actos users were twice as likely to develop bladder cancer after taking the medication for two years. That July, the Canadian Medical Association Journal found that patients taking Actos were 22 percent likelier to develop bladder cancer.

Actos also already bears a Black Box Warning, the U.S. Food and Drug Administration’s (FDA’s) most urgent safety notice, stating that the drug may cause or worsen congestive heart failure in some patients. In fact, Actos is not recommended for anyone diagnosed with symptomatic heart failure. Studies have also linked Actos to fractures.

Aleglitazar was designed to treat cardiovascular risk factors and diabetes; however, Roche was testing the drug, not for the way in which it lowers blood sugar, but to determine if the drug could prevent heart attacks and strokes in people diagnosed with Type 2 diabetes, according to the Times. Other drug makers have made similar attempts with similar medications; however, safety problems led to an abandonment of those efforts, as well.

The fact that aleglitazar failed could possibly affect the outcome of Avandia, which works in similar ways, noted the Times. Avandia critics argue that the entire drug class is unsafe and Avandia’s restrictions should not be changed.

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