Rosiglitazone REMS ends, new insulin approved
The FDA has determined that the Risk Evaluation and Mitigation Strategy is no longer necessary to ensure that the benefits of rosiglitazone-containing drugs outweigh their risks.
The Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing medications is being eliminated, the FDA announced on Dec. 16, 2015. These medications are approved as Avandia, Avandamet, Avandaryl, and generics. Drug manufacturers have fulfilled FDA requirements, such as providing training to clinicians about the cardiac risks of rosiglitazone, and the agency has determined that the REMS is no longer necessary to ensure that the benefits of the drugs outweigh their risks, according to an FDA safety alert.
The agency also approved a new insulin glargine injection (Basaglar) to treat type 1 and type 2 diabetes, based on data showing that it was sufficiently similar to an existing insulin glargine injection (Lantus). The manufacturer also submitted safety and effectiveness data from 2 clinical trials of the new drug enrolling 534 and 744 patients with type 1 and 2 diabetes, respectively. The most common adverse reactions were hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, edema, and weight gain. Severe, life-threatening, generalized allergic reactions, including anaphylaxis, or generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, the FDA news release noted.