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.
Loveable book character now in gummy vitamins
SAN CLEMENTE, Calif. Hero Nutritional Products on Tuesday announced the launch of "Clifford, The Big Red Dog" gummy vitamins for children.
"Hero Nutritionals shares a common goal with Scholastic, the publisher of ‘Clifford, The Big Red Dog,’ a well-loved children’s icon for 50 years," stated Jennifer Hodges, Hero Nutritional Products CEO. "Clifford promotes good citizenship, manners and education, and Hero Nutritional Products promotes wellness and nutrition, both providing the building blocks for normal healthy growth and development. … Hero’s goal of promoting health goes hand in hand with Clifford’s 10 ‘Be Big’ ideas.”
"Clifford, The Big Red Dog" gummy vitamins have high levels of folic acid and zinc and contain 100% of the recommended children’s daily amount of vitamin D per serving, and contain natural vitamin E and vitamin C. The gummy vitamins also have omega oils made with cranberry seeds for healthy normal development of children.
"Clifford, The Big Red Dog" gummy vitamins will be available in food, drug, grocery and mass merchandise stores including Target, Walgreens, Lewis Drug and Rite Aid.
A50-count (25 serving) bottle retails for a suggested $7.99 and will come in two multivitamin + brain health varieties including the original multi-fruit flavor and a new sweet and tart sour flavor. Special promotions can be found on the Clifford vitamin website.
FDA approves multiple sclerosis drug Gilenya
SILVER SPRING, Md. The Food and Drug Administration has approved a drug for reducing relapses in patients with multiple sclerosis.
The FDA announced Wednesday the approval of Swiss drug maker Novartis’ Gilenia (fingolimod) capsules, saying it was the first oral drug that can slow the progression of disability in patients with MS and offered an alternative to injected drugs.
Around 400,000 people in the United States and 2.1 million worldwide have MS, according to the National Multiple Sclerosis Society.