New Warnings Announced for Type 2 Diabetes Drug Actos

New Warnings Announced for Type 2 Diabetes Drug ActosThe European Medicines Agency (EMA) has announced that the Takeda Pharmaceutical drug for type 2 diabetes, Actos, should carry even more warnings about its dangerous affects and possible link to bladder cancer after a safety review was performed on the medicine, Reuters reports.

According to the news source, Europe's drug regulating agency stated that despite the drug's prominent use for treating type 2 diabetes, it still carries an increased risk of bladder cancer. The agency suggested that a regular review of the efficacy and safety of the drug should be performed and catered to the treatment of each individual patient.

In June, France and Germany suspended the use of Actos as well as another leading diabetes drug, Competact, after studies conducted by a French institution found there was a link to increased risk of bladder cancer among patients of both drugs. Other countries of the European Union are treading cautiously around the the use of the drug, awaiting an official decision from the EMA, the media outlet stated.

Although Actos was approved for use in Europe in 2000, its potential risk for bladder cancer has been at the forefront of discussion ever since the studies were conducted.

In response to EMA's suggestions of higher warnings, the Japanese pharmaceutical company initially stated they had no plans for a recall of Actos, citing that U.S. regulators had not mentioned any need for a recall of its high-selling product, according to Reuters.

But in a statement released just 24 hours after claiming they had no plans for an Actos recall, Takeda stated they would voluntarily withdraw both Actos and Competact from markets in France at the request of the French health regulatory authority. The company plans to work with French authorities to begin the withdrawal because of the heightened risk of bladder cancer the French study found.

The decision to work with France in the recall came after Takeda was notified that the EMA was conducting an on-going review of the product to determine the risks.

Although, the company still insists the product is safe, stating it "is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications."

Recently, the U.S. Food and Drug Administration voted against a new type of drug, which was also developed to treat type 2 diabetes, stating that more information needs to be acquired in order to assess the safety concerns of the medicine before it could be marketed and distributed, the Wall Street Journal reports.

A 9 to 6 vote against the drug stated that data submitted by pharmaceutical companies Bristol-Myers Squibb and AstraZeneca did not provide enough information on the efficacy or safety of the drug dapaglifilozin.

A member of the voting panel, Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, went so far as to say that the new drug would need the "strongest boxed warning discussing cancer risks until more data could be collected," the media outlet stated.

The FDA stated that one of the most prominent issues with the drug was its link to an increased risk of bladder cancer, in a reaction very similar to Actos and Competact. A safety update released by the company said that in 5,478 patients, nine cases of bladder cancer were seen.

According to the National Cancer Institute, statistically, 1.17 percent of men and .34 percent of women will develop bladder cancer between the ages of 50 and 70, with 21.9 percent of those cases leading to fatalities.