FDA actions

An advisory committee to the FDA has recommended moving hydrocodone/acetaminophen (Vicodin, Norco) from schedule III to schedule II later this year. The move would put the drug in the same category as morphine and oxycontin, and would require a handwritten, tamper-proof prescription for every prescription and refill. Vicodin — the most widely prescribed drug in this country — is at the center of the controversy regarding prescription drug abuse, which has become "epidemic" in this country, according to the CDC. The United States consumes 99% of all the hydrocodone produced worldwide, and deaths attributable to prescription opioid abuse skyrocketed in the last 2 years, outpacing deaths from illegal opioid drugs, including heroin. The move is supported by some advocacy groups, including an endorsement by the American Academy of Pain Medicine, but not by others. Some physicians are concerned that the schedule change will be a major inconvenience for legitimate pain patients and their physicians, who will be required to write a tamper-proof prescription for each refill of the drug.

The FDA has approved an over-the-counter version of topical oxybutynin for the treatment of overactive bladder in women ages 18 and older. The approval is for women only, with oxybutynin available to men by prescription only. The anticholinergic drug has been used for years by prescription for this indication. In studies of more than 5000 subjects, it was determined that consumers can understand the labeling and "properly select whether the product is right for them." Merck will market the product as a patch that is replaced every 4 days under the trade name Oxytrol for Women.

The FDA has lowered the recommended doses for zolpidem (Ambien) for women. The agency based its recommendation on findings that the popular insomnia drug might impair alertness the next morning if taken at recommended doses. The recommendation is also based on findings that zolpidem stays in the body longer than previously thought, especially in women who process the drug somewhat slower. The new recommended maximal dose for women has been lowered from 10 mg to 5 mg for the immediate-release product, and from 12.5 mg to 6.25 mg for the extended-release (Ambien CR). The FDA further recommends that zolpidem and all insomnia drugs should be used at the lowest dose needed to treat symptoms in both men and woman.

The FDA has approved alogliptin for the treatment of type 2 diabetes. The drug is the fourth dipeptidyl peptidase-4 inhibitor after sitagliptin (Januvia), saxagliptin (Onglyza), and linagliptin (Tradjenta). Takeda Pharmaceuticals has been seeking approval for more than 5 years, dealing with the FDA's tighter standards for new diabetes drugs. The approval was based on 14 trials involving about 8500 patients as well as five ongoing postmarketing trials. The agency also approved two additional combinations of alogliptin with metformin and pioglitazone. Alogliptin alone will be marketed as Nesina, alogliptin/metformin will be marketed as Kazano, and alogliptin/pioglitazone will be marketed as Oseni. Both combination products carry boxed warnings (for lactic acidosis associated with metformin and heart failure associated with pioglitazone). All three are distributed by Takeda Pharmaceuticals.

Johnson & Johnson is one step closer to approval of canagliflozin, the first of a new type of diabetes drug. The Endocrionologic and Metabolic Drugs Advisory Committee voted 10 to 5 in favor of approving the drug while still expressing some concern about the cardiovascular safety of the agent. Canagliflozin is an oral inhibitor of the sodium glucose cotransporter 2 (SGLT2) that reduces reabsorption of glucose in the kidney, resulting in increased urinary glucose excretion with a consequent lowering of plasma glucose levels as well as weight loss. If eventually approved by the FDA, it would be the first SGLT2 inhibitor on the U.S. market. The FDA denied a similar drug 1 year ago (dapagliflozin) because of increased risk of bladder and breast cancer. The favorable vote was based on clinical trials of more than 10,000 patients worldwide which showed that the drug improves blood sugar levels and led to modest weight loss as well as reduction in blood pressure.


This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5404. E-mail: neill.kimball@ahcmedia.com.