Antidepressant approved for anxiety disorder
[black small square] Eli Lilly's antidepressant duloxetine (Cymbalta) has been approved for a new indication, the treatment of generalized anxiety disorder (GAD).
The safety and efficacy of duloxetine in the treatment of GAD was shown in three randomized, double-blind, placebo-controlled studies in more than 800 nondepressed adults with generalized anxiety disorder. In all studies, duloxetine significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale, compared with placebo. Patients in the studies who were taking duloxetine also reported greater improvement in functional impairment associated with GAD, including improved ability to perform everyday activities at work, home, and in social situations.
Duloxetine was previously approved to treat major depressive disorder and management of diabetic peripheral neuropathic pain in adults. Duloxetine is not approved for use in pediatric patients.
Orlistat OTC approved to promote adult weight loss
[black small square] The FDA has approved an over-the-counter (OTC) formulation of orlistat (Alli) capsules for use in conjunction with a reduced-calorie, low-fat diet and exercise to reduce overweight in adults. Alli is a product of GlaxoSmithKline.
The OTC 60 mg capsule of Alli is one-half the strength available by prescription (Xenical, a product of Roche Laboratories). Alli is taken three times daily with meals containing about 30% fat or 15 grams. Because Alli can reduce the absorption of some fat-soluble vitamins and beta carotene, patients should be counseled to take a multivitamin once daily at bedtime to ensure adequate nutrition.
Orlistat is a low-dose lipase inhibitor intended to help patients lose 50% more weight compared with dieting alone. In clinical studies, most people lost 5 to 10 pounds during a 6-month period.
Starter packs of Alli contain 60, 90, or 150 capsules, and portable references that include a booklet on weight loss tips and a healthy eating guide. A free membership in a program to help promote weight loss and healthy eating is also included.
The most common side effect associated with orlistat is bowel changes, including gas with oily spotting and loose stools. Eating a low-fat diet reduces the likelihood of this effect.
Alli is not recommended for patients with chronic malabsorption syndrome or cholestatis, and is contraindicated in pregnant or breastfeeding women and in patients who have had an organ transplant or are receiving cyclosporine therapy.
New med available for type 2 diabetes
[black small square] 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.
According to Merck, the new medication addresses the three key defects of type 2 diabetes: diminished insulin release, uncontrolled production of glucose, and insulin resistance. Furthermore, 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 recommended
[black small square] 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, but it usually follows the recommendation.
Consumers should not buy Accutane online
[black small square] The FDA is warning consumers not to buy isotretinoin (Accutane or any of its generic versions) over the Internet because it bypasses important procedures that ensure 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 potential dangers associated with taking the drug, including the possibility of birth defects, miscarriage, and fetal deaths if a pregnant woman uses isotretinoin. Isotretinoin can also cause serious and harmful side effects that include serious mental health problems.
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 page address is http://www.fda.gov/buyonline/accutane. The Web page will appear in online search results for Accutane or one of the generic versions of isotretinoin.
Label change for all sleep-disorder medications
[black small square] The FDA has asked all manufacturers of 13 sedative-hypnotic drugs, used to induce and/or maintain sleep, to strengthen their labeling to include stronger language about potential risks of taking the medications. 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).
According to the FDA, a review of postmarketing adverse event information for these medications has led the agency to conclude 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 labeling to include warnings about anaphylaxis and angioedema and complex sleep-related behaviors that may include sleep-driving, making phone calls, and preparing and eating food while asleep.
The FDA also requested that manufacturers of sedative-hypnotic drugs develop patient medication guides for these products to inform consumers about associated risks and precautions that can be taken.
Questions surround safety of rosiglitazone
[black small square] A recent meta-analysis of rosiglitazone (Avandia) indicated a significant increase in the risk of myocardial infarction and a risk of death from cardiovascular causes that had borderline significance. The authors conducted a literature search and used the FDA Web site and a clinical-trials registry maintained by the drug manufacturer. Criteria for inclusion in the meta-analysis were: a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability outcome data for myocardial infarction and death from cardiovascular causes. The authors acknowledge that the study had limitations, including a lack of access to original source data, which would have enabled time-to-event analysis.
GlaxoSmithKline, manufacturer of the drug, defended rosiglitazone in a letter to The Lancet, citing data that suggest the actual number of heart attacks is only 0.6% for both the rosiglitazone group and the control group. The company says that, overall, the heart attack safety profile is similar to two other widely used generic diabetes medicines.