Monday, March 12, 2012

Benefit-Risk Balance Deemed Positive for Type 2 Diabetics Taking Pioglitazone

Following safety reviews of the drug pioglitazone—a medicine used in the treatment of Type 2 diabetes—the European Medicines Agency delivered their decision that while there is a marginally increased risk of bladder cancer in those taking the drug, it remains a viable treatment option for some patients. Pioglitazone, also sold under the brand name Actos, is used along with a sensible diet and exercise program to increase the body’s sensitivity to insulin, thereby controlling blood sugar levels.

Reducing Potential Risks
The EMA’s conclusions following extensive study of the drug was that the slight increased risk of bladder cancer could be alleviated through implementation of a more stringent screening of potential patients. Medical professionals are warned against prescribing pioglitazone in any patients with a history of bladder cancer, and to exercise caution when prescribing the drug to the elderly as well. Those patients deemed good candidates for pioglitazone should nonetheless be monitored closely every three to six months to ensure the benefits continue to outweigh the risks.

High Doses, Significant Duration Linked
The results of the controlled epidemiological studies determined that the small risk associated with pioglitazone was seen primarily in those patients who took the drug for significant lengths of time and in the highest doses. Even though the studies showed only a 0.15% increase in risk of bladder cancer this does not mean that those who are prescribed the drug for short term use have no risk at all of contracting bladder cancer.

Further Studies Necessary
Following a series of studies on the drug, the EMA’s Committee for Medicinal Products for Human Use (CHMP) believes there is further need for analysis of the types and severity of bladder cancer in those patients treated with the drug. The CHMP hopes to reveal any possible correlation between incidence of bladder cancer and the age of the patient, the dose of the drug or the duration of the use in further studies. In short, medical professionals are advised to continue to use pioglitazone in those patients who are responding positively to the drug, operating under the belief that the advantages outweigh the possible risks.

Notice to Current Users of Pioglitazone
It is extremely important that patients who currently take pioglitazone follow the directions given by their physician exactly, never taking more or less than directed, and discussing any concerns with a medical professional. While pioglitazone controls Type 2 diabetes, it cannot cure it, and can take as long as two weeks to begin stabilizing your blood sugar. Many patients are started on the lowest dosage which is then gradually increased until full health benefits are reached. The goal of further study is to more fully characterize the associated risks of the drug as well as determine specific measures for minimizing those risks.

Author: Sullo & Sullo Attorneys

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