Saturday, January 14, 2012

Actos® and Congestive Heart Failure

The drug Actos, also known as pioglitazone is marketed by Takeda Pharmaceuticals and Eli Lilly for the treatment of Type 2 diabetes. The drug was approved in 1999, and although the manufacturer touts it as a miracle drug which has reduced the number of diabetes cases by as much as 70%, the side effects may far outweigh the benefits. A study done in 2003 by the Mayo Clinic definitively linked Actos to swelling in the feet, lung fluid retention, shortness of breath and congestive heart failure. The most recent studies have strongly indicated that Actos may also be responsible for a number of incidences of bladder cancer in those who have taken the drug in higher dosages or for longer than twelve months.

The American Diabetes Association presented a research report at a meeting in San Diego this past June which reported that Actos enhanced the risk of macular edema by as much as six times, causing thickening and swelling of the retina and leading to blindness. Another study which was reported in the American Heart Association Journal in August, 2010, associated Actos with an increased risk of death due to congestive heart failure. Although the FDA had mandated a black box warning for Actos regarding possible heart failure risks in 2007, the warnings became even more stringent this past June.

When the heart is unable to pump adequate amounts of oxygen-rich blood to the body, congestive heart failure can occur and can also affect the kidneys, causing them to lose their capacity to expel harmful levels of sodium and fluids, and triggering the body to stubbornly hang on to even more water. Congestion of the lungs with fluids or harmful liquids which gather in the liver can occur, damaging the patient’s ability to breathe as well as to clear the body of harmful toxins. Actos can also cause the extremities to swell from the accumulation of fluids, especially in the ankles and feet. This means that the person who takes Actos may be at a considerably higher risk of congestive heart failure than a person not taking the drug. One of the warnings on the Actos patient guide states that any edema which is directly caused by Actos is generally reversible when the drug is discontinued, and that edema of this type will not normally require hospitalization unless there is corresponding congestive heart failure.

If left untreated, congestive heart failure can influence almost every vital organ in the body, and the management of the disease can range from addressing reversible factors such as medications which cause edema or much more seriously, a heart transplant or specific mechanical therapies. One doctor who headed up the Mayo Clinic study put the risk of congestive heart failure due to Actos use from low to very high depending on the specific patient’s prior cardiac history. Still other physicians believe that one major question is being omitted from the studies of Actos, and that is whether this particular diabetic drug actually allows diabetics to feel better and live longer rather than focusing solely on lowering blood sugar. If, as it appears from numerous studies, Actos can lead to such serious diseases as congestive heart failure and bladder cancer, then it seems apparent that physicians should consider alternative therapies.

Author: Sullo & Sullo Attorneys

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