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FDA Approves New Drug for Type 2 Diabetes

Actoplus Met Combines 2 Widely Used Diabetes Medications
By
WebMD Health News

Aug. 30, 2005 -- The FDA has approved a new drug called Actoplus Met for type 2 diabetes, states a news release from the drug's maker, Takeda Pharmaceuticals North America.

The drug combines two widely used type 2 diabetes drugs: Actos and metformin. Actoplus Met should be available by October, according to the news release.

Actos targets insulin resistance, in which the body falters in its response to insulin, a hormone that controls blood sugar. Metformin is used to curb blood sugar production by the liver.

Diet and exercise are also recommended for people with type 2 diabetes.

"Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease," states the Takeda news release.

Company's Cautions

The news release states that patients who shouldn't take the new drug include:

  • People with kidney disease
  • People 80 or older whose kidneys don't work properly
  • People with a condition known as metabolic acidosis (too much acid produced by the body)
  • People with heart failure requiring treatment (moderate to severe heart failure)
  • People who are hypersensitive to any of Actoplus Met's ingredients
  • People who drink excessive amounts of alcohol
  • People with type 1 diabetes
  • People with active liver disease

The news release also states that patients should talk to their doctors about halting the drug during severe infections or X-ray studies using intravenous contrast dye, and that blood tests for liver problems should be done before starting Actos or Actoplus Met and periodically afterward.

In addition, the company notes that Actos and Actoplus Met may increase swelling that can lead to or worsen heart failure.

Takeda's news release also states that a small number of people who have taken metformin (which is part of Actoplus Met) have developed a rare, potentially fatal condition called lactic acidosis. In those patients, lactic acid builds up in the blood. The condition is mainly seen in people with kidney problems.

Finally, the news release advises patients to consult their doctors immediately if they experience rapid weight gain, fluid retention (swelling), shortness of breath, nausea, vomiting, stomach pain, tiredness, appetite loss, dark urine, or yellowing of the skin.

Takeda Pharmaceutical Company is Japan's largest pharmaceutical company, the news release notes.

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