Sunday, January 27, 2013

The Dangers of Actos and the FDA Warnings

How the Dangers of Actos Could Affect You

Actos (pioglitazone) is a prescription drug used in the treatment of Type 2 Diabetes. Approved in 1999, the drug has been on the market for over thirteen years, and at one time was considered a safe alternative to the drug Avandia (which was targeted for contributing to adverse cardiovascular events in users). Unfortunately, adverse events began occurring in Actos users as well. These problems included cardiovascular issues such as heart attack as well as a forty percent increase in bladder cancer in those Actos users who had been taking the drug for an extended period of time. Liver failure and bone fractures were also more common in those taking Actos. Since the overseas recalls of Actos, two new studies have confirmed bladder cancer risk, and a June 2012 study definitively linked the increase of macular edema to Actos as well.

What You Need to Know About a Potential Actos Recall by the FDA

Although Germany and France both halted the use of Actos due to its link to bladder cancer and heart failure in particular, the United States has been slow to follow suit. The FDA states they are closely following ongoing Actos studies both in the United States and in other countries and the agency has issued an announcement which highlights the potential dangers of Actos. In order for the FDA to instigate a recall of a drug, they must conclude that there is a reasonable probability that the drug will lead to serious adverse health issues or death. While the FDA ordered updated labeling for the drug detailing known warnings, in May of 2012 the agency reduced its requirement that Actos patients be given a separate Medication Guide detailing the risks. The FDA, in the end, stated that “The benefits of blood-sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”

How an Actos Lawyer Can Help

At the time Actos gained FDA approval in 1999, specific clinical trials demonstrated an increased rate of bladder cancer, both in human and animal trials. At that time Takeda Pharmaceuticals, the manufacturer of Actos conducted a 10-year study to investigate bladder cancer risks; after the first half of the study had passed, an increased bladder risk was seen in Actos patients. Legal action has been accumulating against Takeda as well as Eli Lilly & Co., who originally was involved in the joint marketing of Actos. According to Bloomberg News, Takeda could ultimately face literally thousands of lawsuits; victims of Actos have already filed such a high number of lawsuits that they have been consolidated in an MDL while both California and Illinois currently have a significant number of consolidated lawsuits filed in their state.

Why the Actos Warning Should Concern You

Actos became the highest-selling diabetes drug after Avandia, its closest competitor, was shown to cause a higher than normal risk of heart attack among users. Both Avandia and Actos come from the same family of drugs (thiazolidinediones) and work by increasing the body’s sensitivity to insulin. An Associated Press article stated that Takeda Pharmaceuticals, the manufacturer of Actos had over $3.4 billion in Actos sales in 2011 alone. Any patient who has taken Actos and suffered any unusual side effects should see their physician immediately and have any necessary testing done as recommended.

Author: Sullo & Sullo Attorneys

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