All Manufacturers of TZD’s to Strengthen Warning on Heart Failure Risk

The FDA announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning — FDA’s strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.

After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).

FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda, to address these concerns.

"This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."

FDA’s review of adverse event reports found cases of significant weight gain and edema — warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

FDA’s review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
U.S. Food and Drug Administration
================================
FACT: Diabetes patch three years away: A group of Melbourne scientists are on the brink of developing a world first patch to treat diabetes. Biotechnology company, Phosphagenics Ltd has developed a ‘non invasive’ insulin which could end the need for injections.  When the patch is stuck onto the patient’s arm, millions of tiny balls of insulin squeeze themselves between the skin cells then they are absorbed into the skin. At the moment the insulin is in a gel form but scientists hope to create a patch within the next few months. They believe the drug could be on the market within three years.

================================