Victoza, Similar Diabetes Drugs Raise Safety Concerns

<"">Victoza, a Type 2 Diabetes drug approved just last year, is raising concerns about pancreatitis. According to the Institute for Safe Medication Practices’ (ISMP) latest “QuarterWatch” report, Victoza has been associated with a growing number of pancreatitis cases since its January 2010 approval. The report voices concern that other newer diabetes drugs, including <"">Byetta and Januvia, may share an elevated risk of pancreatitis, although possibly to differing degrees.

Victoza is an injectable medication that acts on a hormone in the gastro-intestinal tract called glucagon-like-peptide-1 (GLP-1), which results in lower blood sugar levels. Byetta, also an injectable, is part of this class. Two other diabetes drugs, Januvia and Onglyza, are oral medications that prolong the action of GLP-1 by slowing the body’s ability to break down this same enzyme.

According to the ISMP, the approval of Victoza was controversial at the U.S. Food & Drug Administration (FDA) because of uncertainty about its cardiovascular risks, and animal studies showing an increased risk of thyroid cancer. The report asserts that pre-approval testing is simply too short to determine whether the drug’s benefit-risk balance is favorable. However, “FDA and others feared that if truly rigorous long-term testing were required of such drugs, the time and costs of developing new agents for diabetes might become prohibitive,” the ISMP said. As a result, the group asserts that uncertainty about risks and benefits continues to surround new-generation diabetes drugs like Victoza.

According to the QuarterWatch report, data to the FDA’s Adverse Event Reporting database show Victoza accounted for 70 cases of acute and chronic pancreatitis in the third quarter of 2010, and 105 cases since approval nine months earlier. This result was surpassed only by, Byetta, with 78 cases. Onglyza accounted for 14 cases of pancreatitis in the third quarter, while Januvia was the subject of 18 reports.

The report asserts that evidence is growing drugs that act on GLP-1 increase the risk of pancreatitis, and that the risk may be higher for injectable like Victoza and Byetta. But, it points out that “studies to determine the incidence, identify differences between drugs and provide the basis to weigh these risks against possible benefits have not been performed.” It further states that pancreatitis is a risk factor pancreatic cancer, and notes that animal data suggests a thyroid cancer risk for Victoza.

While the ISMP report concedes that GLP-1 agents like Victoza and Byetta represent a “promising new approach” to treating Type 2 Diabetes, it also points out that it is unknown whether any of these drugs reduce or increase risk of heart attack and stroke, the biggest health threats faced by people with Type 2 Diabetes. Meanwhile, despite the safety concerns surrounding Victoza, it has become widely used with over 200,000 prescriptions dispensed in the first nine months after the FDA granted it approval.

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