Product Updates

News

New Treatment for Late-Onset Pompe Disease
The FDA approved alglucosidase alfa (Lumizyme) for patients ≥8 years of age with late-onset, noninfantile Pompe disease, a rare genetic disorder. Alglucosidase alfa, marketed by Genzyme Corporation, is believed to work by replacing the deficient acid alpha-glucosidase necessary for proper muscle functioning, thereby reducing the accumulated glycogen in heart and skeletal muscle cells.

Alglucosidase alfa is being approved with a Risk Evaluation and Mitigation Strategy. It will only be available through a restricted distribution system called the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program to ensure that it is used by the correct patient group. Alglucosidase alfa will carry a Boxed Warning because of the risk of anaphylaxis, severe allergic reactions, and immune-mediated reactions. The approval of alglucosidase alfa will ensure that treatment is available for all US adult Pompe patients in need of treatment.

The safety and efficacy of alglucosidase alfa are based on a clinical study in 90 patients, 10 to 70 years of age, with late-onset Pompe disease. The safety and effectiveness have not been evaluated in patients with infantile-onset Pompe disease or in patients ≤8 years of age with late-onset disease. The FDA states that these patients should be treated with Myozyme, rather than Lumizyme.
Recommendations Revised for Rotavirus Vaccines

The FDA revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and healthcare professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee.

According to the FDA, both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.

H1N1 Influenza Virus Test Cleared by FDA
The FDA cleared the Simplexa Influenza A H1N1, a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection. Until this clearance, tests for 2009 H1N1 influenza were only available through an Emergency Use Authorization, which allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test simultaneously amplifies and detects 2 regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. The Simplexa Influenza A H1N1 (2009) test is manufactured by Focus Diagnostics Inc.

Injectable Osteoporosis Treatment for Postmenopausal Women
The FDA approved denosumab (Prolia), an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. Denosumab is manufactured by Amgen Inc and works to decrease the destruction of bone and increase bone mass and strength. An injection of denosumab is recommended once every 6 months.

The safety and efficacy of denosumab in the treatment of postmenopausal osteoporosis were demonstrated in a 3-year, randomized, double-blind, placebo-controlled trial of 7808 postmenopausal women ages 60 to 91 years. Denosumab was approved with a Risk Evaluation and Mitigation Strategy that includes a Medication Guide for patients.

Product Recall

FDA Advises Against Use of Arrow Brand Medicated Oil & Embrocation
The FDA warned consumers not to purchase or use a product called Arrow Brand Medicated Oil & Embrocation. The product is potentially toxic and contains 2 substances, methyl salicylate and camphor, which are poisonous when ingested.

Methyl salicylate and camphor also may be poisonous when applied to a large area of the skin, or when combined with heat to increase absorption of the active ingredients. The FDA announcement said that children are particularly susceptible to poisoning from these ingredients.

FDA preliminary testing on product samples also revealed a compound that appears to be diethylene glycol, an ingredient used in antifreeze, which may be toxic if ingested. The FDA is asking retailers to remove the product from store shelves.

Warnings

Serious Side Effects from Swallowing Topical Benadryl Product
The FDA warned consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.

To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson & Johnson, has changed the product label to add a new, prominent statement “For Skin Use Only,” attached a sticker to the cap of the product that says “For Skin Use Only,” and initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.

The repackaged product is currently stocked in retail stores. The FDA reminds consumers and healthcare professionals to always read the Drug Facts box to identify active ingredients, directions for use, and warnings before using any OTC drug product.

Risks for High-Dose, Long-Term Use of Proton Pump Inhibitors
The FDA warned consumers and healthcare professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

The FDA’s warning and decision to revise the labeling of proton pump inhibitors are based on the review of several epidemiologic studies that reported an increased risk of fractures of the hip, wrist, and spine in patients using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on over-the-counter proton pump inhibitors will address these findings. Consumers also should talk with their healthcare professional about any concerns.

Rare Cases of Liver Injury Reported with Use of Weight-loss Drugs
The FDA advised consumers and healthcare professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat (Xenical) and an over-the-counter version of orlistat (Alli). The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence.

The FDA’s safety information and labeling changes are based on a review of cases of severe liver injury reported in individuals taking orlistat. At this time, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.