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.
Novartis’ Cushing’s disease drug shows promising results in trial
EAST HANOVER, N.J. Swiss drug maker Novartis said its investigational drug is the first to show promise in a late-stage clinical trial for Cushing’s disease, a potentially fatal hormonal disorder.
Novartis announced Wednesday that the drug SOM230 (pasireotide) had reduced cortisol levels in patients with Cushing’s disease. The disease results from a benign pituitary tumor that causes the adrenal glands to produce excess cortisol. This can lead to metabolic and cardiovascular problems and death. Results will be presented at the 14th congress of the European Neuroendocrine Association.
“There is a critical need for a medical treatment for people with Cushing’s disease because currently available options, such as surgery or radiotherapy, are ultimately not effective for many of the patients who suffer from this debilitating disease,” said William Ludlam, director of the Seattle Pituitary Center at the Swedish Neuroscience Institute in Seattle. “The results of this study suggest that pasireotide may help patients achieve biochemical control of their Cushing’s disease and its symptoms by directly targeting the pituitary tumor that triggers excess cortisol production.”