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Monthly Roundup - December 2011

Durasal and Durezol: Potential for Patient Injury Due to Name Mix-Up

The Food and Drug Administration (FDA) is alerting pharmacists and other health care providers of the potential for ocular injury if the unapproved prescription drug Durasal (salicylic acid) is confused with the FDA-approved medication Durezol (difluprednate ophthalmic emulsion). Durasal is a wart removal product, and Durezol is a topical corticosteroid approved for treatment of inflammation and pain associated with ocular surgery. There has been at least one report of serious eye injury due to a patient receiving Durasal instead of Durezol, but other reports of confusion exist. Because Durasal is not an approved product, it did not go through the FDA screening process for look-alike and sound-alike drug names. The manufacturer has not responded to FDA inquiries for Durasal recall.

New Strength of Infant Acetaminophen Poses Dosing Risk

Until recently, infant acetaminophen has only been available in the concentrated drop formulation. Now, in an attempt to standardize strengths of acetaminophen, manufacturers are marketing a new strength of liquid acetaminophen (160 mg/5 mL) and phasing out the concentrated drops (80 mg/0.8 mL or 80 mg/1 mL). However, at this time both products are still on store shelves. Switching the directions or measuring devices between the new strength and the older concentrated drops could result in dosing errors and possibly fatal liver toxicity. The FDA emphasizes that consumers should not interchange dosing devices between products or rely on outside packaging to solely identify the drug; instead look at labeled directions and strengths on the package carefully. Seek the advice of a health care provider for questions about acetaminophen infant dosing and measuring devices.

Anturol (Oxybutynin) Topical Gel Approved For Overactive Bladder

Overactive bladder (OAB) is a common problem in both women and men in the U.S., affecting over 33 million patients. The FDA has approved oxybutynin topical 3% gel (Anturol) in a metered-dose pump formulation for the treatment of overactive bladder. Topical instead of oral oxybutynin allows the drug to by-pass liver metabolism. Avoiding liver metabolism can reduce the incidence of side effects such as dry mouth and constipation. In a 12-week clinical trial, patients receiving oxybutynin gel experienced significantly less OAB symptoms compared to placebo, including a lower number of incontinence episodes, lower daily urinary frequency and less urinary void volume.

Combination Agent Edarbyclor Approved for Hypertension

Edarbyclor (azilsartan medoxomil-chlorthalidone) has been approved by the U.S. Food and Drug Administration (FDA) as the first fixed-dose angiotensin II receptor blocker (ARB) and chlorthalidone combination for the treatment of hypertension in adults. Both azilsartan medoxomil (Edarbi) and chlorthalidone are available as separate agents for lowering blood pressure. In five clinical trials ranging from 8 to 52 weeks, Edarbyclor lowered mean systolic blood pressure more than either azilsartan medoxomil or chlorthalidone monotherapy, and more than the highest approved dose of hydrochlorothiazide-olmesartan (Benicar HCT). Edarbyclor similarly lowered blood pressure across all ethnic groups. The most common side effects were dizziness and fatigue.

Expanded Boxed Warnings for Antiarrhythmic Multaq (dronedarone)

The FDA has completed a cardiac safety review of the antiarrhythmic Multaq (dronedarone). In addition to patients with decompensated heart failure, an increased risk of death, stroke and heart failure may occur in patients with permanent atrial fibrillation (AF) who are treated with Multaq. Multaq doubles the risk of death in both patient populations, and doubles the risk of stroke and heart failure hospitalization in patients with permanent AF. AF data was gathered from the PALLAS trial, which was terminated early due to a significantly higher rate of cardiac events and death in the Multaq groups compared to placebo.

FDA Warning: Over-the-Counter Diet Fad HCG is Illegal

Weight loss can weigh heavily on our mind this time of year, with upcoming New Year’s resolutions. But weight loss should be gradual, sensible and safe. The Food and Drug Administration (FDA) has issued seven letters to companies illegally selling over-the-counter (OTC) homeopathic human chorionic gonadotropin (HCG) as unapproved weight loss products. These products, marketed as oral drops, sprays, and pellets can be found online or in shops. FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it and stop following the recommended, unsafe calorie-restrictive diet. Prescription HCG is FDA-approved for female infertility and other conditions, but weight-loss claims for OTC HCG are unsupported.

Posted: December 2011