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New Drugs/Drug News/New Medical Devices May 2013


Diclegis for Morning Sickness

Doxylamine succinate/pyridoxine HCl (vitamin B6) has been approved for the treatment of nausea and vomiting during pregnancy. Diclegis, made by Duchesnay, is a new version of Bendectin (Merrell Dow), which was the target of more than 300 lawsuits regarding birth defects 30 years ago. Although it was later found that the risk of birth defects was not increased, Merrell Dow stopped production because of the cost of litigation. In recent studies, Diclegis did not pose an increased risk of fetal harm. In Canada, the company sells a generic version (Diclectin).

Sources: FDA, April 8, 2013; Associated Press, April 9, 2013; The New York Times, June 19, 1983

Heptavalent Botulism Antitoxin

The first botulism antitoxin has been approved to treat patients who have been exposed to the nerve agent. Cangene’s Botulism Antitoxin Heptavalent is a mixture of antibody fragments derived from horse plasma. This product neutralizes the seven botulinum nerve toxin serotypes that cause botulism.

Sources: FDA, March 22, 2013; MedPage Today, March 25, 2013

Tecfidera for MS

Dimethyl fumarate (Tecfidera, BG-12, Biogen Idec) delayed-release capsules are used to treat relapsing, remitting multiple sclerosis (MS). Dimethyl fumarate has been used in other countries to treat psoriasis. It is also used as a fungicide and as a desiccant in furniture manufacture.

In two trials, dimethyl fumarate was superior to placebo in preventing relapses.

For more information, please see the Pharmaceutical Approval Update column on page 246.

Sources: FDA and MedPage Today, March 27, 2013

Dotarem, a Contrast Agent

Gadoterate meglumine (Dotarem, Guerbet), a gadolinium-based contrast agent, is now approved for use in magnetic resonance imaging (MRI) of the brain, spine, and surrounding tissues in patients 2 years of age and older. All gadolinium agents carry a boxed warning about the risk of nephrogenic systemic fibrosis. Other gadolinium contrast media used in central nervous system MRIs are Magnevist, Prohance, Omni-scan, Optimark, Multihance, and Gadavist.

Source: FDA, March 21, 2013

Invokana for Diabetes

A first-in-class type-2 diabetes drug, the sodium glucose co-transporter-2 (SGLT-2) inhibitor canagliflozin (Invokana, Janssen), is used in conjunction with diet and exercise to improve glycemic control in adults. This compound does not affect insulin; instead, it blocks reabsorption of glucose by the kidney, increasing glucose excretion directly into the urine.

Janssen’s cardiovascular study, CANagliflozin cardioVascular Assessment Study (CANVAS), showed a nonsignificant increase in major adverse cardiovascular events in the first 30 days of starting therapy. The approval was based on nine trials in which canagliflozin was found to be non-inferior to glimepiride (Amaryl, Sanofi) and sitagliptin (Januvia, Merck).

Last year, the FDA declined to approve the SGLT-2 inhibitor dapagliflozin because of concerns about breast and bladder cancer risks, but these risks were not seen with canagliflozin.

Sources: FDA and MedPage Today, March 29, 2013


Tobramycin for Cystic Fibrosis

The TOBI Podhaler (Novartis) is an inhalable powder formulation of the antibiotic tobramycin, which combats Pseudomonas aeruginosa infection in patients with cystic fibrosis. The plastic inhaler is used twice daily for 28 days, followed by a 28-day withdrawal period before starting again. The formulation was recommended for approval by a vote of 13 to 1 in September 2012 despite earlier concerns that adverse coughing events might spread the organisms that the drug was meant to treat.

Sources: FDA, March 22, 2013; MedPage Today, March 25, 2013

Starter Packet for AndroGel

AndroGel 1.62% (AbbVie) topical testosterone will be sold in a pocket-sized packet to treat men with hypogonadism. The starter packet contains 40.5 mg of testosterone in 2.5 g of gel, equal to two presses of an earlier metered-dose pump version. A second packet contains 20.25 mg of testosterone in 1.25 g of gel, providing a dose adjustment. The recommended dose is one application daily. Doses range from 20.25 mg to 81 mg.

This packet competes with Eli Lilly’s Axiron, which is applied under the arm. To avoid absorbing testosterone through the skin, women and children should not touch the application site of men who use AndroGel.

Source: MedPage Today, March 16, 2013

Lower-Dose Prolensa After Cataract Surgery

A new formulation of a once-daily nonsteroidal anti-inflammatory drug (NSAID) has been approved for the treatment of pain and inflammation in patients recovering from cataract surgery. Bausch & Lomb’s 0.07% bromfenac ophthalmic solution (Prolensa) is in line to replace the 0.09% bromfenac solution.

Warnings of sulfite allergic reactions, delayed healing, and a potential for cross-sensitivity are being added to the label.

Source: Medscape, April 8, 2013

Generic Doxycycline

A 200-mg form of doxycycline hyclate delayed-release tablets (Doryx, Warner Chilcott/Mayne) has been approved to treat or prevent bacterial infections.

Source: Globe Newswire, April 12, 2013


Compounding Pharmacy Recall

Med Prep Consulting, a compounding pharmacy in Tinton Falls, New Jersey, recalled all of its products after fungal particles were found in bags of magnesium sulfate intravenous (IV) solution. The firm temporarily halted production and shipping because sterility could not be ensured at the facility. The affected drugs might have been distributed in New Jersey, Pennsylvania, Delaware, and Connecticut. The recall included products distributed through March 15, 2013.

Sources: FDA and MedPage Today, March 18, 2013

Plan B Birth Control OK For Younger Women

A federal judge has reversed a government decision that restricted over-the-counter access to the levonorgestrel emergency oral contraceptives Plan B and Plan B One-Step to women and girls 17 and older. Plan B was first approved for use in 1999 by prescription only.

Sources: Boston Globe and MedPage Today, April 5, 2013



Guardian Hemostasis Valves

Class I recalls have been issued for two hemostasis valves made by Vascular Solutions because of a risk of air embolism. The Guardian II and Guardian II NC Hemostasis Valves are used to reduce blood loss during catheterization procedures. Model Nos. 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272, and 8274, made from February 2012 to February 2013, are affected.

Source: MedPage Today, March 28, 2013

OneTouch Glucose Meters

LifeScan, a unit of Johnson & Johnson, has recalled blood glucose meters that may shut down at extremely high glucose levels. At readings of 1,024 mg/dL and above, the units can fail to alert the patient and may simply power down instead, raising the risk of serious adverse events.

Source: MedPage Today, March 26, 2013

Animas Insulin Pump

The FDA has issued a Class I recall for the Animas/Johnson & Johnson 2020 insulin infusion pump because of false alarms that could be triggered, causing the device to stop working.

All lots made from March 1, 2012, to November 30, 2012, may contain a malfunctioning component that can trigger a false warning, eventually resulting in hypoglycemia. A current software malfunction also prevents the device from operating after December 31, 2015.

Animas recomended that customers return the product to the company and adopt the OneTouch Ping. This is Johnson & Johnson’s second diabetes-related recall in a month.

Sources: FDA, Fierce Medical Devices, and MedPage Today, April 5, 2013


Marvin M. Goldenberg PhD, RPh, MS

Name: COBAS AmpliPrep/COBAS TaqMan Hepatitis C Diagnostic Test, Version 2.0

Manufacturer: Roche Molecular Diagnostics, Basel, Switzerland

Approval Date: March 6, 2013

Purpose: The assay is used as adjunct to markers of infection in patients with chronic hepatitis C virus (HCV) infection.

Description: This in vitro nucleic acid amplification test quantifies HCV RNA genotypes 1 to 6 in human EDTA plasma or serum and is used to predict the probability of early sustained virological responses during antiviral therapy.

Benefit: Viral load assays help physicians tailor therapy for each patient.


Name: 3-D Ear Scanning System

Manufacturer: Lantos Technologies, Inc., Cambridge, Mass.

Approval Date: March 18, 2013

Purpose: The Lantos system provides a streamlined process for obtaining measurements for custom-fit ear devices.

Description: A portable hand-held scanner includes a video-otoscope that generates a three-dimensional scan of the ear and ear canal in less than 1 minute.

Benefit: The Lantos system replaces the laborious and time-consuming process of taking a silicone impression to produce an audio device. The new system enables the audiologist to collect more data about the ear canal than was possible before.



On February 25, 2013, Symbios Medical Products recalled its GOPump Elastomeric Infusion Pump Kit (Part No. 510076) because of the potential for the flow restrictor bead to become displaced from its fitting, causing too high a flow rate.

Source: FDA,