Actos Health Risks and the Benefits-Risks Ratio Rule

There are health risks that go with any type of drug, be it prescription or nonprescription. The rule of thumb is, for as long as the expected benefits from a certain drug outweigh all its possible health risks, then it is worth a try.

The benefits-risks ratio protocol seems appropriate until you consider how a drug’s safety profile is established particularly for prescription ones. From then, it becomes dubious.

As of this writing, the Food and Drugs Administration’s (FDA) drug approval system largely addresses efficacy profile prior the launch of a new drug and the safety profile during a postmarketing surveillance (PMS). That means as a standard practice, a drug is refined, validated or denied after a drug has been released on the market. The information from consumers, who in the hope for some relief decided to use the drug but in the process contracted a disease, will be vital to the process.

Suffice to say, while you are being convinced that a prescription drug’s benefits offset its dangers, the physician has no solid clue about the degree of its risks.

This is the case with Actos, the current best-selling diabetes drug in the country.

Bladder cancer is certainly Actos’ chief health risk. Confirmed by three large-scale studies in 2011, Actos carries a 40 percent increased risk for bladder cancer. For the more than 2.3 million Americans who were prescribed Actos in 2010, the development deserved the growing number of Actos lawsuits.

Occupying the second spot is congestive heart failure (CHF). Actos and its heightened risk for CHF was established by a study published in the Journal of the American Medical Association (JAMA) in 2007. In the same year, The FDA merited Actos and other thiazolidinediones (TZDs) a black box warning, the toughest caution the drug agency gives to any prescription drug with debilitating health risk.

However, it seems that the atmosphere in the medical community in 2007 was like that of The Emperor’s New Clothes: no one dared to point that the emperor had no clothes. Everybody went with the hype and believed, oh yes, the emperor had new, elegant, for great-mind-only clothes!

In the case of Actos, no medical practitioner dared to stop or even slow down prescribing the drug. They actually overprescribed even after FDA deemed Actos causing debilitating health risk. As a result, Actos became one of the top-grossing drugs in the country in 2008. Worst, Actos raked in as much as $4.6 billion in sales in 2010.  The belief that Actos’ benefits are still worth its risks continues.

Rounding off the top three Actos side effects are liver damage and kidney dysfunction. Premarketing trial revealed that Actos could also cause a rise in alanine aminotransferase (ALT) enzyme three times above the normal level. Increase in ALT is a sign of heart problems, kidney dysfunction, and liver damage.