Trending News Today: FDA Proposes Restricting 3 Substances from Bulk Drug Compounding
Top news of the day from across the health care landscape
On Monday, officials with the FDA proposed excluding 3 substances from a list of ingredients that could be used for compounding medications in bulk, Reuters reported. According to the article, the substances are vasopressin, bumetanide, and nicardipine hydrochloride, which are all ingredients of 1 or more FDA-approved drug products. The action is the first time the FDA has moved to exclude any substance from the list of ingredients that is used to produce bulk compounded medications, the article reported.
Weight loss drug Belviq was deemed successful in a long-term heart safety study, demonstrating no increased cardiovascular risks associated with the product, the Associated Press reported. According to the article, researchers tested the drug in a study of 12,000 individuals who were either obese or overweight with heart disease risk factors, such as high blood pressure or cholesterol. Although the drug did not raise heart risks, it did not lower risk either, the article reported.
The FDA rejected Akcea Therapeutics’ application to market Waylivra, also known as volanesorsen, its drug for familial chylomicronemia syndrome, STAT reported. According to the article, the drug received a 12-8 vote in favor of approval during an advisory committee meeting, but panelists expressed concern that some patients on the drug had extremely low platelet counts. Waylivra is based on antisense oligonucleotides, which aim to destroy incorrect genetic instructions before a cell can use them, the article reported.