Update 11/4/11: Update 11/4/11: The FDA is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 to continue prescribing and receiving rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl). After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies and will only be available by mail order through specially certified pharmacies participating in the program. 

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Update 2/3/11: Avandia labels now contain updated information about cardiovascular risks and use in certain patients.

The FDA announced that information on the cardiovascular risks (including heart attack) of the diabetes drug, rosiglitazone, has been added to the physician labelig and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used: 

• In patients already being treated with these medicines 
• In patients whose blood sugar cannot be controlled with other antidiabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact) 

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Update 5/18/11: FDA announced new restrictions to the prescribing and use of rosiglitazone-containing medicines (Avandia, Avandamet™, and Avandaryl™). Healthcare providers and patients must enroll in a special program to prescribe and receive these drugs.

FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products. 

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 Click here for the Avandia-Rosiglitazone Medicines Access Program. 

Update 11/2/09: FDA has approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. 

Changes include: 

• Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease 
• Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (30 to 50 ml/min) 
• Recommendations that healthcare professionals monitor carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney function is suspected while using the product 
• Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta 

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