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FDA Approved Diabetes Drug Despite Hints at Cancer Risk
Date:2/18/2010

also be a sign of pancreatitis, and people taking the drug should be evaluated for that possibility, according to the FDA.

All drugs are associated with risks, Mahoney noted, and Victoza does bring benefit to those taking it.

"Liraglutide is an effective anti-diabetic drug, and controlling blood sugar in patients not adequately treated with other available therapies is very important in preventing the long-term complications of diabetes," she said.

"For this reason, FDA considered the benefits to outweigh the risks, provided that prescribers carefully read the labeling and recommendations for use and select their patient appropriately for liraglutide use," Mahoney said.

She noted that Victoza has one advantage over its only other competitor in this class of drugs, Byetta. Byetta is administered as a twice-daily injection, whereas Victoza is a once-daily injection, Mahoney noted.

The agency is requiring that a medication guide be provided with every prescription filled for Victoza.

"Prescribers will need to carefully review the package insert before considering liraglutide for their patients," Mahoney said. "Patients need to read the medication guide. If after reading the medication guide the patient still has questions or concerns, these need to be raised with the health-care provider."

Two diabetes experts agreed that Victoza could be an important addition to the treatment of type 2 diabetes.

Dr. Joel Zonszein, a professor of clinical medicine in the Clinical Diabetes Center at the Albert Einstein College of Medicine in New York City, said that any controversy over cancer risk is "much to-do about nothing."

Although this rare thyroid cancer can be seen in rodents, "there is no evidence that this is the case in humans," he said. "It is not good to create panic for something that has a very low risk."

According to Zonszein, people should be more concerned about havin
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