Epocrates Drug Updates - Editor's Pick

December 4, 2014
FDA MedWatch Safety Alert for Tecfidera

FDA is warning that a multiple sclerosis (MS) patient treated with Tecfidera (dimethyl fumarate) in a clinical trial developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient was not taking other drugs associated with PML. Information describing this PML case will be added to the Tecfidera drug label. Healthcare providers should advise patients to report symptoms suggesting PML, and stop Tecfidera if PML is suspected.
Tecfidera

Recent Updates

December 4, 2014
Erratum
The OxyContin and generic oxycodone monographs have been updated to correct the dosing for patients with hepatic impairment. The start dose should be decreased by 50-66% and titrated slowly in these patients. Please update your Epocrates app regularly to ensure that you always have the latest content.
OxyContin

November 20, 2014
Long-term Antiplatelet Therapy FDA Medwatch Safety Alert
The FDA is reviewing preliminary data from the Dual Antiplatelet Therapy (DAPT) study, which showed that long-term antiplatelet therapy following drug-eluding coronary stent implantation reduced MI and stent thrombosis risk, but increased the risk of overall non-cardiovascular mortality. The trial compared treatment with aspirin plus clopidogrel (Plavix) or prasugrel (Effient) for 30 months versus treatment for 12 months. At this time, the FDA advises healthcare providers not to change prescribing habits of these drugs, as their cardiovascular benefits outweigh their potential risks.
Plavix and Esbriet

November 6, 2014
Ofev and Esbriet, First Drugs Approved for Idiopathic Pulmonary Fibrosis
The FDA recently approved Ofev (nintedanib) and Esbriet (pirfenidone), two "first-in-class" agents for the treatment of idiopathic pulmonary fibrosis (IPF). Both drugs have been shown to slow progression of lung function decline in IPF patients. Ofev is a kinase inhibitor that blocks multiple pathways involved with intracellular signaling of fibroblasts, while the mechanism of action for Esbriet is currently unknown.
Ofev and Esbriet , First Drugs Approved for Idiopathic Pulmonary Fibrosis

October 30, 2014
Harvoni, New Combination Approved for Hepatitis C
The FDA recently approved Harvoni (ledipasvir/ sofosbuvir), a once-daily oral combination tablet for the treatment of chronic hepatitis C genotype 1 infection. Harvoni contains ledipasvir, a non-structural protein 5A (NS5A) inhibitor, and sofosbuvir, a non-structural protein 5B (NS5B) polymerase inhibitor previously approved as Sovaldi.
Harvoni, New Combination Approved for Hepatitis C

October 9, 2014
Hydrocodone Combination Products Now Schedule II
Effective October 6, 2014, the DEA has moved hydrocodone combination products from Schedule III to Schedule II. Hydrocodone combination products are among the most widely prescribed drugs in the United States, and are approved for the treatment of pain and for cough suppression.
Epocrates Drug Updates

New Drug Monographs

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