FDA changes prescribing, dispensing restrictions for rosiglitazone
The FDA has determined that recent data on rosiglitazone-containing drugs (Avandia, Avandamet, Avandaryl, and generics) do not show an increased risk of myocardial infarction compared with metformin and sulfonylurea. Therefore, the agency announced that it is removing the prescribing and dispensing restrictions for rosiglitazone medications that were instituted in 2010. The change is based on a review of data from RECORD, a large, long-term clinical trial, and is supported by a comprehensive, outside expert reevaluation of the data conducted by the Duke Clinical Research Institute.
Prior to this action, the FDA had required a Risk Evaluation and Mitigation Strategy (REMS) program for rosiglitazone, which restricted the use of rosiglitazone medications to help ensure that their benefits outweighed the risks.
According to the FDA, although some scientific uncertainty regarding the cardiovascular safety of rosiglitazone medications remains, the reevaluation of the RECORD study data found that concern to be “substantially reduced,” and the rosiglitazone REMS program requirements will be modified.
The agency recommends that patients with type 2 diabetes continue to work closely with their healthcare professionals to arrange appropriate treatment options. Enrollment in the REMS program is no longer required to prescribe, dispense, or receive rosiglitazone medications. Sponsors of these medications will continue to educate prescribers on the current state of knowledge regarding the cardiovascular risk of these medications.
FDA approves first adjuvanted vaccine to prevent H5N1 avian flu
The FDA approved the influenza A (H5N1) virus monovalent vaccine, adjuvanted, for the prevention of H5N1 influenza. The vaccine is for use in people 18 years of age or older who are at increased risk of exposure to the H5N1 influenza virus, commonly known as avian or bird flu.
The vaccine is not intended for commercial availability; the U.S. Department of Health and Human Services purchased the vaccine from the manufacturer (ID Biomedical Corp. of Quebec City, Canada) for inclusion in the National Stockpile for distribution by public health officials if necessary.
The immune response was evaluated in about 2,000 vaccinated adults. Ninety-one percent of those between the ages of 18 and 64 years of age and 74% of those 65 years of age and older who received the two-dose regimen developed antibodies at a level expected to reduce the risk of contracting influenza.
The vaccine is made using an egg-based manufacturing process. It contains the adjuvant AS03, an oil-in-water emulsion. The vaccine is administered via intramuscular injection in two doses 21 days apart.
The most common adverse reaction reported in clinical studies was injection site pain. Muscle aches, headache, fatigue, and injection site redness and swelling were also common.
Perrigo acetaminophen infant suspension liquid is recalled
The Perrigo Company has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2-oz and 4-oz bottles with syringes in a box under store brand products, including Babies “R” Us, Care One, and more. The full list of affected brand names and products is available at: www.fda.gov/Safety/Recalls/ucm373338.htm.
The recall is being undertaken because of the remote possibility that a small number of packages might contain an oral dosing syringe without dose markings, which can result in inaccurate dosing, especially in infants.
No action is needed if the oral dosing device contained in the packaging has dose markings for 1.25, 2.5, 3.75, and 5 mL. If the oral dosing device does not have dose markings, consumers should not use the product and should call Perrigo's Consumer Affairs Department at 800-719-9260.