New Medication for Type 2 Diabetes
The FDA has approved Merck's new type 2 oral diabetes treatment, Janumet, which contains a dipeptidyl peptidase-4 inhibitor (sitagliptin) and metformin. The medication is approved as an adjunct to diet and exercise to improve blood glucose control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with sitagliptin and metformin.
Patients treated with Janumet in clinical trials experienced weight loss comparable to metformin alone, with no increased risk of hypoglycemia, edema, or gastrointestinal disturbances beyond metformin alone.
A randomized, placebo-controlled trial of 701 patients with moderately-elevated hemoglobin A1C levels inadequately controlled on metformin showed that patients taking Janumet experienced significant additional mean reductions in A1C beyond that achieved by patients who continued on metformin alone.
Janumet is dosed twice daily with meals and should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Like metformin, Janumet's labeling contains a boxed warning for lactic acidosis, a rare but serious complication that can occur during treatment due to metformin accumulation.
Vaccine-like Prostate Cancer Treatment
A panel of advisors for the FDA voted to recommend the approval of Provenge, a cellular therapy against prostate cancer. Patients undergoing the treatment have immune cells removed and treated with immune agents. The cells are reintroduced to the body with chemical programming that is designed to let them mount an immune response against cancer cells, according to Dendreon Corporation, the maker of Provenge.
Studies suggest that Provenge may slow by 1 to 2 weeks the progression of prostate cancer in men who have cancer that does not respond to hormone treatment. There was also some evidence that men who were treated lived longer than those who took a placebo. In one study, men who received Provenge lived an average of 3.3 months longer; in a second study, they lived 4.5 months longer.
The FDA is not bound by the recommendations of its advisory committee; however, it usually follows the recommendation.
Consumers Should Not Buy Accutane Online
The FDA is warning consumers not to buy isotretinoin (Accutane or any of its generic versions) over the Internet because it bypasses important procedures to ensure that patients can take the medication safely. The agency has dedicated a new page on its Web site to warn potential users of isotretinoin about the dangers associated with taking the drug.
The latest warning is in addition to the safeguards already in place to reduce the risks of isotretinoin, including the iPLEDGE program, which ensures that women using isotretinoin do not become pregnant and that women who are pregnant do not use isotretinoin.
The new Web site address is http://www.fda.gov/buyonline/ accutane.
Label Change for All Sleep-Disorder Medications
The FDA has asked manufacturers of 13 sedative-hypnotic drugs used to induce and/or maintain sleep to include stronger language about potential risks on the labeling. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving (driving while not fully awake after taking a sedative-hypnotic product with no memory of the event).
The FDA concluded that labeling changes are needed to inform healthcare providers and consumers about risks. Manufacturers of this class of drugs are already working with the FDA on revisions to include label warnings about anaphylaxis, angioedema, and complex sleep-related behaviors.
The FDA also requested that manufacturers develop patient guides about associated risks and precautions that can be taken.