Articles Posted in Actos Bladder Cancer

Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

There’s nothing more life changing than a cancer diagnosis. Whether it’s you or a close family member, no one’s life is the same. One of the first thoughts is “why”. Why me?

Up until that moment, you probably thought that things like this didn’t happen to you. 15 years ago, cancer didn’t seem as common. Today, I don’t know anyone whose life was not affected by cancer in anyway, be it through own diagnosis, or that of a family member or close friend.

Though there are plenty of theories, and new studies each day are suggesting that different foods and other ingestible products contain cancer causing agents, not many doctors will pin point the exact cause of a patient’s cancer. Looking back, we may think of things that we could have done, if anything at all, to prevent this disease.

What’s worse it to find out that your cancer could have been preventable, but was caused by no fault of your own. Adding salt to the wounds, it could have been caused by following your doctors orders and taking proper care of yourself.

On June 15, 2011, the U.S. Food and Drug Administration (FDA) issued a safety alert informing the public that using the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer. On August 4, the FDA informed the public and medical professionals that a label change, informing patients of the risk, had occurred.

The FDA recommends that Doctors not prescribe Actos for patients with active bladder cancer, and to be weary when prescribing it to patients with a prior history of bladder cancer.
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Actos is an equal opportunity Type 2 diabetes drug that causes bladder cancer in men and women. While both sexes are at risk, men are more at risk.

However, women who take Actos for type 2 diabetes not only are at risk for bladder cancer but are also at risk for fractures known as secondary osteoporosis.

What is worse? Women, what’s worse diabetes or the cure? Type 2 diabetes is manageable with a complementary prescription drug and nutrition. But bladder cancer and bone fractures?

At the School of Medicine, Health Policy and Practice, University of East Anglia in Norwich, UK, their study aimed to determine the risk of fractures associated with thiazolidinedione therapy and to evaluate the effect on bone density. Pioglitazone (Actos) and Rosiglitazone (Avandia) are in the thiazolidinedione (TZD) class of drugs.

For the purpose of the blog post, let’s focus on Actos.
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This past June, government officials in France and Germany removed the diabetes medication Actos (pioglitazone) from their markets after a study by French researchers discovered a correlation between the drug and an elevated risk of bladder cancer. However, even though the U.S. Food and Drug Administration (FDA) issued a public cautionary statement about the risk and updated the warning information on the product’s label and patient information, Actos and other drugs containing pioglitazone are still available on the U.S. market.

Actos is a leading medicine in a small class of drugs to treat blood sugar levels in Type II diabetes. The FDA said that from January 2010 to October 2010, approximately 2.3 million people received prescriptions for Actos or another drug with pioglitazone. In 2009, Actos sales in the U.S. were around $3.4 billion, as reported by The New York Times. Other drugs it is used in tandem with are Actoplus Met, Actoplus Met XR, and Duetact. The FDA’s warning claims that the Actos bladder cancer risk is highest for individuals using the drug on a long term basis, over a year, and in larger increasing dosages.

An increasing amount of individuals in the U.S. have started a class action lawsuit against the company that makes Actos. Users affected or injured by drug claim that the company did not adequately investigate the drug prior to releasing it on the market and also failed to inform the public of its serious dangers. If you’ve used Actos, or have been harmed by the drug (or any drug containing pioglitazone), contact the Pennsylvania dangerous drug attorneys with Anapol Weiss at (866) 735-2792 for a free case review with an attorney.

After the U.S. Food and Drug Administration (FDA) cautioned in June that the diabetes drug pioglitazone (known as brand name “Actos”) presents an increased risk of bladder cancer for ongoing users, the start of a class action lawsuit involving dozens of affected individuals quickly followed in September.

Specifically, the drug is prescribed to adults with type 2 diabetes mellitus to assist with the regulation of blood sugar. From January 2010 to October 2010, the FDA reported about 2.3 million individuals with prescriptions that contained the substance. In addition to Actos, pioglitazone is also found in Actoplus Met, Actoplus Met XR, and Duetact.

The FDA issued the following guidelines regarding Actos, and any other medical products containing the drug:

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