The FDA has approved eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist and delta-opioid receptor antagonist, for oral treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

Ibutilide fumarate (Corvert - Pharmacia & Upjohn), a new antiarrhythmic drug for intravenous use, has been approved by the US Food and Drug Administration for acute termination of atrial fibrillation or flutter of recent onset.

Sibutramine hydrochlorid monohydreate (Meridia - Knoll), which is structurally related to amphetamine, has been approved by the FDA for treatment of obesity. It is classified by the Drug Enforcement Agency (DEA) as a schedule IV controlled substance.

A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been approved by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. It is the first drug to be approved for this indication. The CDC has been recommending Truvada off-label for pre-exposure prophylaxis in men who have sex with men since 2011.2 A 30-day supply of Truvada costs about $1160.3CLINICAL STUDIES — Approval for the new indication was based on 2...

The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling,...

The FDA has approved changes to the labeling of erenumab-aooe (Aimovig)1, a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) blocker approved in 2018 for prevention of migraine. The new label contains a warning about hypersensitivity reactions, including rash, angioedema, and anaphylaxis, that have been reported with post-marketing use of the drug.According to the label, most of these reactions were not serious and occurred within hours after receiving the drug, but some occurred more than one week after administration. Because these reactions are voluntarily...

Olsalazine sodium (Dipentum - Pharmacia), a dimer (two molecules linked by an azo bond) of 5-aminosalicylic acid, was recently approved by the US Food and Drug Administration for oral use to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine (Azulfidine; and others).

Fentanyl, a synthetic opioid previously available for parenteral use in anesthesia (Sublimaze), has now been marketed in a controlled-release transdermal formulation (Duragesic - Janssen) for use in patients with chronic pain severe enough to require opioid analgesia. It is not recommended for treatment of postoperative pain because of the drug's slow onset and prolonged duration of action.

Metformin (Glucophage - Bristol-Myers Squibb), a hypoglycemic agent, was recently marketed in the USA for oral treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not adequately controlled by diet alone. Previously marketed in more than ninety countries, including Canada, metformin (dimethylbiguanide) is chemically related to phenformin (phenylethylbiguanide), which was withdrawn from the US market in 1976 because it caused a high incidence of lactic acidosis. In approving metformin, the US Food and Drug Administration stipulated that a post-marketing controlled...