FDA Actions

The FDA has asked the manufacturers of propoxyphene-containing pain medications (Darvon®, Darvocet®, and generics) to withdraw them from the market. The withdrawal is based on new data showing the drugs are associated with serious and fatal heart arrhythmias. Health care professionals are advised to stop prescribing propoxyphene and patients are asked to contact their health care providers to discuss switching to other pain medications. Propoxyphene has been the target of consumer groups for more than 30 years because of evidence of poor efficacy in treating pain and a high level of side effects including falls.

The FDA has approved duloxetine (Cymbalta®) for the treatment of chronic musculoskeletal pain. Duloxetine, a serotonin-norepinephrine reuptake inhibitor, was previously approved for treating depression, generalized anxiety disorder, diabetic neuropathy, and fibromyalgia. The new indication for musculoskeletal pain includes low back pain and osteoarthritis. The expanded indication was based on the results of four double-blind, placebo-controlled trials, which showed that patients treated with duloxetine had significantly greater pain reduction than those patients treated with placebo. Duloxetine is marketed by Eli Lilly and Company.

The FDA has approved lurasidone for the treatment of schizophrenia in adults. The drug is classified as an atypical antipsychotic, and like other drugs in this class, carries a boxed warning regarding an increased risk of death associated with off-label use to treat behavioral problems in older adults with dementia. Common adverse reactions include drowsiness, feelings of restlessness, nausea, agitation, and Parkinsonian symptoms such as bradykinesia, tremor, and muscle stiffness. Lurasidone will be marketed by Sunovion Pharmaceuticals as Latuda™.

The FDA has approved a new injectable cephalosporin, ceftaroline, to treat community-acquired bacterial pneumonia (CABP) and bacterial skin infections, including those caused by methicillin-resistant Staphylococcus aureus. Ceftaroline was approved based on data from four studies that showed the drug to be as effective as ceftriaxone for the treatment of CABP and as effective as vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections. The recommended dose for patients with normal renal function is 600 mg given as a one-hour IV infusion every 12 hours. Ceftaroline is marketed by Forest Laboratories as Telflaro™.

The FDA's Vaccines and Related Biological Products Advisory Committee has recommended an expanded indication for Gardasil®, Merck's quadravalent human papillomavirus vaccine to prevent anal intraepithelial neoplasia and anal cancer in males and females ages 9-26. The approval was based on a phase III double-blind, placebo-controlled trial in which more than 4000 males were randomized to receive the three-dose vaccine or placebo. There was a significant reduction in the rate of anal intraepithelial neoplasia or anal cancer, especially in men who have sex with men. The vaccine is already approved for prevention of genital warts and cervical, vulvar, and vaginal cancer in females ages 9-26 and prevention of genital warts in males ages 9-26.