Serotonin Syndrome

Market watch

New Drugs, Indications, and Dosage Forms

• Almivopan (Entereg) has been approved by the Food and Drug Administration (FDA) for treating postoperative ileus in hospitalized adults only. The dose is one 12 mg capsule given immediately pre-operatively and another 12 mg dose given twice daily for up to seven days post-operatively (not to exceed 15 doses).
• Darunavir (Prezista) is available as a new 600 mg tablet.
• Duloxetine (Cymbalta) has been FDA approved as a once-daily (60 mg) treatment for fibromyalgia in adults.
• Ropinirole extended-release (Requip XL): has been FDA approved as a once daily treatment for Parkinson’s disease.
• Zoledronic acid intravenous injection (Reclast IV) has been FDA approved for the prevention of new clinical fractures in patients who have recently had a low-trauma hip.

Pipeline

A supplemental new drug application for IV esomeprazole (Nexium) has been submitted to the FDA for the management of peptic ulcer bleeding subsequent to endoscopy.

New Information

Metered-dose inhaler (MDI) phase-out: MDIs for asthma and chronic obstructive pulmonary are subject to the Clean Air Act and the Montreal Protocol. The Montreal Protocol is an international treaty signed in 1987 to protect the ozone layer. It includes the phaseout of substances believed to cause ozone layer depletion.

The 1978 rule prohibits the use of chlorofluorocarbons (CFCs) as propellants in self-pressurized containers in any food, drug, medical device, or cosmetic with a subsequent phasing-out out of these containers. Many of the drug products have switched to non-CFC MDIs (e.g., hydrofluoroalkane [HFA] propellants) and dry-powder inhalers (DPIs).

The deadline for product removal of CFCs is at the end of 2008, although the change has been slow. Some newer CFC-free inhalers include Proair HFA, Proventil HFA, Ventolin HFA, and Xopenex HFA. Some of these branded products are more costly then their generic counterparts. Please convert any of your patients who are still using CFC inhalers to CFC-free inhalers.

The FDA is planning public service announcements for patients to educate them about the changes. The newer albuterol HFA inhalers have prescription assistance programs for patients in financial need from the manufacturers (e.g., GlaxoSmithKline, Teva, Schering-Plough, Sepracor). The Partnership for Prescription Assistance can be reached at (888) 477-2669 or at www.pparx.org.

New Warnings

Becaplermin gel (Regranex), the recombinant human platelet-derived growth factor used to treat lower extremity diabetic neuropathic ulcers, has undergone a label change with the addition of a boxed warning. A literature review determined there is a five-times greater risk of death in those who used three or more tubes of the gel, compared with those who did not use becaplermin gel. The follow-up duration was not long enough to detect new cancers. The warning also notes becaplermin only should be used when the benefits outweigh the risks and it should be used with caution in patients with known cancers.

Conventional antipsychotic agents: The FDA has notified healthcare providers that both conventional and atypical antipsychotics are associated with increased mortality risk in elderly patients treated for dementia-related psychosis subsequent to a continued information review of conventional antipsychotics. Antipsychotics are not FDA approved to treat dementia-related psychosis. The boxed warning and warning sections of all antipsychotic agents have been updated to include this new information.—MK