FDA to allow GSK’s Avandia, with restrictions
SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.
The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.
The FDA is requiring GSK to develop a restricted access program for the drug under a risk evaluation and mitigation strategy. Under the REMS, Avandia will be available to patients only if they cannot control their glucose levels with Actos (pioglitazone), a drug made by Takeda in the same class as Avandia.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA commissioner Margaret Hamburg said. “We are seeking to strike the right balance to support clinical care.”
Actos has some issues of its own. Last week, the FDA said it would conduct a safety review of the drug after receiving data from a study conducted by Takeda suggesting that some patients taking the drug for the longest periods of time and in the highest dosage could be at risk for bladder cancer. The study did not show an overall association between taking Actos and the risk of bladder cancer, and the FDA said it had not concluded that a risk existed.
Abbott recalls specific Similac powder infant formulas
ABBOTT PARK, Ill. Abbott on Wednesday initiated a proactive, voluntary recall of certain Similac powder infant formulas in the United States, Puerto Rico, Guam and some countries in the Caribbean following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product, produced in one production area in a single manufacturing facility.
"Abbott understands that parents expect to feed their children only the highest-quality product,” stated Holger Liepmann, EVP Abbott Nutrition. “We are taking this action so that parents know that the infant formula products they provide unquestionably meet the highest-quality standards for which they are known. We regret any inconvenience this situation poses to parents and consumers."
The Food and Drug Administration has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.
To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit Similac.com/recall, and type in their lot number to determine if their product is affected, or call (800) 986-8850.
No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas, and all powder and liquid specialty formulas, such as Similac Expert Care Alimentum, Elecare, Similac Expert Care Neosure, Similac Human Milk Fortifier, and metabolic formulas for inherited disorders.
Dietitian joins local ShopRite stores
KEASBEY, N.J. ShopRite stores in Canton and West Hartford, Conn., are looking to help shoppers make healthier food choices by introducing a registered dietitian, according to a local news report.
Registered dietitian Angela Corcoran will be available, effective immediately, to help shoppers. She will conduct free grocery shopping tours, healthy cooking classes, offer recipe and pantry makeovers, and coordinate other health-and-wellness initiatives and nutritional programs in-store, the report stated.
“Having a dietitian in store is just another way that we go above and beyond to provide value and service to our customers,” store president Chuck Joseph was quoted as saying.