Rosiglitazone – New Concerns Regarding Increased Risk of Heart Attacks

by Dr. Simi Paknikar on  October 6, 2010 at 2:27 PM Health Watch   - G J E 4
Rosiglitazone is an antidiabetic drug used to treat adult patients with type 2 diabetes along with diet and exercise. It is used alone or in combination with other drugs. It is available in brands such as Avandia, Avandamet and Avandaryl in the United States. Brands available in India include Reglit, Rezult, Rosicon and Senzia.

Rosiglitazone belongs to a group of drugs called thiazolinediones. The first drug from this class, troglitazone, was withdrawn due to reports of liver damage.

Rosiglitazone acts by increasing insulin sensitivity in various tissues. Thus it increases utilization of glucose and reduces blood glucose. It may also reduce the amount of glucose released by the liver. It is taken once a day. Maximum effect may be seen only after 6 to 12 weeks of treatment.

Rosiglitazone causes adverse effects such as anemia, weight gain, upper respiratory tract infection, headache, macular edema (swelling inside the eye) and increase in bone fractures in female patients taking the drug. It causes fluid retention i.e. edema and hence should not be used for patients with heart failure. It should not be used along with insulin or nitrates since it increases the chances of heart failure and heart attack respectively in these patients. It should also be avoided for patients with liver disease.

Rosiglitazone has been found to increase incidence of heart attacks and deaths due to heart disease in clinical trials. The FDA has issued a warning in this regard. Based on latest data available, the FDA has decided to restrict the use of rosiglitazone. Patients will be able to take rosiglitazone for the first time only if their blood glucose cannot be controlled with other drugs and they decide not to take pioglitazone after consulting their health care professionals. If a patient is already on rosiglitazone and is benefited by its use, he may continue to take it provided he is aware of the risk. The FDA continues to review new data about rosiglitazone and will publish additional guidelines as necessary.

The European Medicines Agency (EMA) has banned the use of rosiglitazone. Patients already taking the drug have been asked to switch to other alternatives after consulting their doctor. The EMA believes that the benefit of rosiglitazone no longer outweighs the risk of heart attack.

Shanghai is also closely watching the adverse effects of rosiglitazone following the decisions taken by FDA and EMA. India has yet to take any action against the drug. A committee has been set up to review the available safety information

GlaxoSmithKline, the company that manufactures Avandia plans to stop marketing the drug in all countries.

If you are taking this drug please consult your doctor before stopping it.

Source: Medindia

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