Epocrates Drug Updates - Editor's Pick

October 5, 2015
FDA MedWatch Safety Alert for Tramadol

The FDA is evaluating the use of the opioid tramadol in patients aged 17 years and younger due to a rare but serious risk of bradypnea/dyspnea. Tramadol is not approved for use in children; however, data show that clinicians have been using it “off label” to treat pediatric patients. Clinicians should consider prescribing alternative FDA-approved pain medications for children, especially post tonsillectomy/adenoidectomy.

September 21, 2015
FDA MedWatch Safety Alert for Clozapine

The FDA is revising the requirements for monitoring, prescribing, and dispensing the schizophrenia drug clozapine (Clozaril, FazaClo, Versacloz, and generics) to address continued safety concerns and new knowledge about its risk of severe neutropenia. Changes to the requirements include: using only absolute neutrophil count (ANC) to monitor neutropenia rather than WBC + ANC; lowering the ANC level at which treatment interruption is necessary for clozapine-associated neutropenia to 1,000 cells/µL; and allowing clozapine as a treatment option for patients with benign ethnic neutropenia. Starting on Oct. 12, clozapine will be available through a single new centralized risk evaluation and mitigation strategy (REMS) program. Clinicians and pharmacies must be certified in the program in order to prescribe and dispense the drug.

September 14, 2015
FDA MedWatch Safety Alert for Picato

The FDA has received reports of severe allergic reactions and herpes zoster reactivation associated with Picato (ingenol mebutate) gel, a treatment for actinic keratosis. Severe eye injuries and skin reactions have also been reported, some of which occurred due to improper use. Advise patients to follow instructions for use and not to apply Picato near the mouth, lips, or eyes.

FDA MedWatch Safety Alert for Gilenya

The FDA warns that new cases of the rare and potentially fatal brain infection PML have been reported in patients taking the multiple sclerosis drug Gilenya (fingolimod). These are the first cases in patients taking Gilenya who had not been previously treated with an immunosuppressant. Advise patients to immediately report any signs or symptoms of PML including weakness, discoordination, or changes in mental status, vision, strength, or balance.

September 7, 2015
FDA MedWatch Safety Alert for Picato

The FDA’s recent approval of Zarxio (filgrastim-sndz) has made it the first official biosimilar agent available in the United States. It is supplied as prefilled syringes containing 300 or 480 mcg. Zarxio is closely related to Neupogen (filgrastim), which stimulates neutrophil production in the bone marrow. Zarxio is approved as a mobilizing agent in preparation for autologous bone marrow transplantation, as well as for five of the six indications listed in the Neupogen labeling, including for use after intensive chemotherapy in patients with cancer. For now, each biosimilar product will be listed with a four-letter suffix (e.g. ‘-sndz’) to distinguish it from the reference drug. The FDA is finalizing the standards for naming these agents.

Noteworthy Recent Updates

August 31, 2015
Praluent Approved for Primary Hyperlipidemia
The FDA recently approved Praluent (alirocumab), a monoclonal antibody, indicated as adjunct therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. Praluent is the first available proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. PCSK9 inhibitors prevent PCSK9 binding to LDL receptors, decreasing LDL receptor degradation and increasing LDL clearance. Praluent is administered as a subcutaneous injection every 2 weeks.

August 31, 2015
Entresto Approved for Chronic Heart Failure
The FDA recently approved Entresto (sacubitril/valsartan), a new drug therapy for treating NYHA Class II-IV heart failure patients. Entresto is the first combination product containing an ARB and sacubitril, a neprilysin inhibitor. Neprilysin inhibition decreases natriuretic peptide degradation, which results in vasodilation, natriuresis, and diuresis. Entresto is contraindicated with concomitant ACE inhibitor use as clinical trials demonstrated combined ACE and neprilysin inhibition was associated with increased angioedema risk. A 36-hour washout period is needed after ACE inhibitor discontinuation and Entresto initiation.

Clinical Impact: Sacubitril represents a new pharmacological class, neprilysin inhibitors, which are a novel treatment option for chronic heart failure patients. Additional clinical experience is needed to determine the long-term safety of the drug.

July 24, 2015
FDA MedWatch Safety Alert for Proglycem
The FDA is warning that infants and newborns treated with Proglycem (diazoxide) for hypoglycemia may develop pulmonary HTN. The agency has identified 11 cases of pulmonary HTN in infants and newborns treated with diazoxide since its approval in 1973. Clinicians should closely monitor babies receiving Proglycem, especially those with risk factors for pulmonary HTN. If pulmonary HTN is identified, Proglycem should be discontinued.

July 24, 2015
Kybella Approved for Submental Fat
Kybella (deoxycholic acid) is the first injectable treatment available to improve the appearance of fullness associated with submental fat. The drug is indicated for the reduction of moderate to severe submental fat convexity and is administered as up to 50 SC injections per treatment. The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

July 24, 2015
FDA MedWatch Safety Alert for NSAIDs
The FDA is strengthening an existing warning that non-aspirin NSAIDs increase MI and stroke risk. MI and stroke risk may occur within the first weeks of NSAID treatment, and risk may increase with higher doses or longer treatment duration. Advise patients to use the lowest effective amount for the shortest effective treatment duration, and to seek immediate medical attention if cardiac signs or symptoms occur.
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October 5, 2015
The epinephrine monograph has been updated to reflect the preferred formulation in the alternative dosing for NALS/NRP – 1:10,000 solution. Please update your Epocrates app regularly to ensure that you always have the latest content.

August 31, 2015
The Anaspaz monograph has been updated to clarify the age ranges for pediatric dosing. For the treatment of GI tract spasm and bladder spasms in patients 2-11 yo, Anaspaz should be given at a dose of 0.0625-0.125 mg PO/SL q4h prn. Please update your Epocrates app regularly to ensure that you always have the latest content.