Epocrates Drug Updates - Editor's Pick

March 25, 2015
FDA MedWatch Safety Alert: Chantix

The FDA recently warned that the smoking cessation medication, Chantix (varenicline), may affect how patients react to alcohol. There have been reports of decreased alcohol tolerance, including increased drunkenness, unusual or aggressive behavior, or amnesia. Seizures have also been reported in patients taking varenicline. Some patients did not have a history of seizures or had a seizure disorder that was well-controlled. In most cases, seizures were reported within the first month of varenicline use.

Noteworthy Recent Updates

March 23, 2015
FDA MedWatch Safety Alert: Testosterone Products
On March 3, 2015, the FDA clarified that testosterone products are only approved for men with low testosterone levels caused by approved medical conditions. Testosterone products are not indicated for use in men with low testosterone levels due to aging, as benefits and safety risks have not been established. The FDA advisory committee also concluded that there is a potential increased risk of cardiovascular events in patients taking testosterone, including heart attack, stroke, and death. Testosterone manufacturers are now required to include these potential risks and clarify the approved indications in their labeling.
testosterone topical

March 11, 2015
Prezcobix and Evotaz Approved for HIV Infection
The FDA recently approved Prezcobix (darunavir/cobicistat) and Evotaz (atazanavir/cobicistat) for treatment-naïve or treatment-experienced HIV infection. Darunavir and atazanavir are both protease inhibitors, while cobicistat functions by boosting protease inhibitor blood levels via CYP3A4 inhibition. Prezcobix and Evotaz are both combined with other antiretroviral agents to form a complete regimen for HIV.

March 2, 2015
Flonase Now Available Over-the-Counter
Flonase (fluticasone propionate nasal) is the latest drug to undergo an Rx-to-OTC switch. Like its prescription-status predecessor, the new OTC product, Flonase Allergy Relief, is available in a 50-mcg/spray strength. The corticosteroid nasal spray is used to treat allergy symptoms in patients ≥4 years old.
Flonase Allergy Relief

March 2, 2015
Ibrance Approved for Metastatic Breast Cancer
Ibrance (palbociclib) is the first FDA-approved cyclin-dependent kinase inhibitor, and it represents a new option for the initial endocrine-based treatment for metastatic, hormone receptor-positive, HER2-negative breast cancer. It is given as 125 mg orally once daily on days 1-21 of a 28-day cycle in combination with letrozole 2.5 mg daily, which is administered on a continuous basis. Notable adverse reactions associated with Ibrance include neutropenia, infections, and pulmonary embolism.

February 23, 2015
Vyvanse – first drug approved for binge eating disorder
The FDA recently approved Vyvanse (lisdexamfetamine) as the first medication to treat binge eating disorder. Use of Vyvanse, a Schedule II drug and CNS stimulant, was expanded to include treatment of moderate to severe binge eating disorder in adults. Vyvanse is also indicated for ADHD in patients ≥6 years old. It is not approved for weight loss.

New Drug Monographs

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March 11, 2015
The zoledronic acid 5 mg injection monograph has been updated to correct the Contraindications/Cautions and Adverse Reactions sections, in order to reflect the safety profile for the therapeutically equivalent generic for Reclast.