Safety Of Diabetes Drugs Questionable

With the recent move of the U.S. Food and Drugs Administration (FDA) to deny Bristol-Myers Squibb Co. and AstraZeneca Plc a clearance to make their experimental diabetes pill available in the U.S. market, there is no arguing that diabetic drugs have their sets of dangers.

On July 19, 2011, makers of dapagliflozin were denied access to the U.S. market over concern for bladder and breast cancer and liver impairment risks of the drug.

Dapagliflozin is the first-of-its-kind diabetic therapy for hyperglycemia. It stood clinical trials and was proven to help patients lose weight and lower blood pressure. One of the most visible side effects of previously launched diabetes drugs was the weight gain among users. While the drug’s capability to aid in losing weight was a remarkable development, FDA’s utmost concern was its safety.

In clinical trials, nine male participants developed bladder cancer, while another nine developed breast cancer. One from the control group also developed breast cancer. FDA also found that the drug has potential liver risks. The FDA believed that the dapagliflozin’s benefits could not outweigh the risks of bladder and breast cancer.

FDA’s intensified inspection of diabetes pills came after two prominent diabetic pills Avandia and Actos were tied to heart attacks in 2010 and Actos to bladder cancer in 2011. Although some of these side effects have been known about for some time. FDA warnings about the dangers of these drugs have spurred thousands of lawsuits.  Actos lawsuits allege that Takeda, the manufacturer of Actos,  knew early on about the drug’s link to bladder cancer. Many of the Avandia lawsuits have alleged that although there were warnings about the severe side effects that were downplayed by the manufacturer.

Avandia (rosiglitazone) took a downturn in 2010 after a series of studies determined its heart risk. FDA then put in effect stringent measures on its use. Avandia could now be used only as a last-resort medication for type 2 diabetic patients. Physicians can only prescribe the medicine after it has been determined that there is no other medication, which will aid in the control of a diabetic’s blood sugar.

The FDA did not place restrictions on prescription and disbursement of the medicine until mid-2011. European Medicines Agency (EMA), on the other hand, banned all rosiglitazone-containing drugs like Avandia, Avandamet, and Avaglim from the market and recommended patients to see their physicians and ask for alternative diabetes drug.

The FDA is still reviewing studies related to Actos (pioglitazone). For the time being, a new label warning of a possible link between Actos and bladder cancer. A black box warning about Actos related  heart problems have been in place for quite some time.

Other diabetic drugs like Januvia (sitagliptin) and Victoza (liraglutide) were linked to life-threatening conditions, as well.

In a study conducted by Larry L. Hillblom Islet Research Centre on 40 human IAPP transgenic (HIP) rats, Januvia, made available in the U.S. market in 2006, was linked to pancreatic cancer and pancreatitis. Victoza, received FDA’s approval in January 2010, was linked to thyroid cancer.

In 2000, the diabetes drug Rezulin (troglitazone) was withdrawn from the U.S. market due to liver failure and an increase in number of deaths among its users. Dr. David J. Graham, associate director of FDA’s Office of Drug Safety, estimated that at least 20 Rezulin patients suffered from liver failure monthly in the course of Rezulin’s availability in the U.S. market.

Like Actos and Avandia, Rezulin is another diabetes drug, which belongs toThiazolidinediones (TZDs), and like any other TZDs, Rezulin’s golden moment was short-lived.

FDA is expected to be more vigilant in its oversight function as an upsurge in number of defective and dangerous drugs were recorded in the last two years.