Saturday, January 14, 2012

Actos® and Cardiovascular Dangers

The drug Actos, marketed by Takeda Pharmaceutical Corporation, is used in the treatment of Type 2 diabetes. Actos largely replaced its predecessor, Avandia, after Avandia was found to have serious risks of heart attack and heart failure. At the time, it was believed that Actos offered much less risk of cardiovascular damage than Avandia. Actos is used to lessen blood glucose labels and improves how the body handles insulin. Type 2 diabetes, which affects between eighteen and twenty million Americans, can cause loss of sight, kidney trouble and cardiovascular illness if left untreated, however it appears that the treatment may also come with its fair share of serious dangers. Just like Avandia, Actos may carry significant levels of cardiovascular risks, however it has not been associated with heart attack deaths in the same way Avandia has.

Although Takeda is in the middle of a ten-year study regarding the safety of Actos, other studies have been conducted as well. One well-known cardiologist, Dr. Steven Nissen of the Clevenland clinic focused his review of Actos dangers, finding that it significantly increases the likelihood of a heart attack by as much as forty-two percent. The FDA issued a black box warning label for Actos in June of 2007 during a House of Representatives hearing. During this hearing the fact that the FDA was aware of the potential cardiovascular risks associated with Actos yet failed to adequately respond was discussed, and since that time both lawmakers and health experts have criticized the FDA for failing to properly safeguard public health.

In fact, as early on as 1999, when Avandia and related drug types first hit the market, Dr. John Buse warned about the potential cardiovascular dangers inherent in this type of drug. Even though Dr. Buse was a prominent endocrinologist as well as the new president of the American Diabetes Association, his concerns were met with threats by the manufacturers of the drugs, and no action was taken to investigate the cardiovascular side effects of Actos. Because the disease of diabetes in itself increases the risk of cardiovascular complications, the fact that the drug used to treat the disease may carry serious cardiovascular risks is of significant concern. Older patients appear to be at an even greater risk of cardiovascular problems than their younger counterparts.

Patients who continue to take Actos as treatment for their Type 2 diabetes are warned to seek medical attention immediately should they experience any symptoms of cardiovascular disease. Symptoms can include edema, shortness of breath, extreme exhaustion, chest pain or discomfort, dizziness, irregular heartbeats, nausea or pain in one or both arms, your left shoulder, the neck, jaw or back. In the case of a heart attack, the symptoms can develop rapidly however in most cases of cardiovascular problems, symptoms will develop over a period of days or even months. Patients who already suffer from cardiac problems should not take Actos, as it could worsen those problems, leading to heart failure, even though it appears that many physicians have been ignoring the 2007 black box warning and continuing to prescribe Actos to patients with known cardiovascular issues.

Author: Sullo & Sullo Attorneys

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