Epocrates Drug Updates - Editor's Pick

April 13, 2015
FDA MedWatch Safety Alert: Feraheme

A new Boxed Warning about the risk of serious, potentially fatal allergic reactions has been added to the Feraheme (ferumoxytol) label. Feraheme is also now contraindicated in all patients with a history of hypersensitivity to any IV iron replacement product. IV iron products should only be given if required, as all IV iron replacement products carry the risk of potentially life-threatening hypersensitivity reactions. Feraheme must be diluted and administered as an IV infusion over at least 15 minutes. Patients receiving Feraheme should be monitored for hypersensitivity signs and symptoms during and for at least 30 minutes after infusion.
Black Box Warning for Feraheme

FDA MedWatch Safety Alert: Interaction between Amiodarone and HCV Treatment
The FDA recently warned that patients may develop serious and life-threatening bradycardia when amiodarone is given either with Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) plus another direct-acting antiviral HCV treatment such as daclatasvir or Olysio (simeprevir). Post-marketing reports included 1 fatality due to cardiac arrest and 3 patients requiring pacemakers, but the cause was undetermined. The FDA will continue its investigation, and recommends against prescribing amiodarone with any sofosbuvir-containing regimen. If no alternative treatment is available, patients must undergo extensive cardiac monitoring.
Harvoni Drug Interactions

FDA MedWatch Safety Alert: Zyprexa Relprevv
Results were inconclusive in an FDA study to determine the cause of elevated levels of Zyprexa Relprevv (olanzapine pamoate) in 2 patients who died. The FDA was unable to exclude the possibility that the fatalities were caused by rapid, but delayed, drug entry into the bloodstream after IM injection. The study suggested increased drug levels could have occurred after death. No changes to Zyprexa Relprevv prescribing, use, or REMS requirements are recommended at this time. Patients should be instructed to read the Medication Guide before each injection and report any signs or symptoms of post-injection delirium sedation (PDSS).
Zyprexa Relprevv

Noteworthy Recent Updates

April 2, 2015
Toujeo Approved for Diabetes Mellitus
The FDA recently approved Toujeo (insulin glargine) for treatment of type 1 and type 2 diabetes mellitus. Toujeo is a long-acting basal insulin that contains the same active ingredient as Lantus, but with three times the concentration (300 units/mL). This formulation of insulin glargine has a delayed onset of 6 hours and a longer duration of action of 24-36 hours. For patients currently controlled on Lantus, a higher daily dose of Toujeo may be required to maintain the same level of glycemic control.
Toujeo (insulin glargine)

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.
Chantix

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.
Prezcobix

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

New Drug Monographs

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Erratum

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.