FDA Denies Expanded Use of Xgeva Pending Clinical Trial
The Food and Drug Administration has voted to deny an expansion of a drug currently on the market due to the dangers that might be posed by the new function that the drug’s makers were hoping to market it for. Xgeva, a drug made by Amgen, has since 2010 been used to prevent bone injuries… read more
FDA Might Allow More Over the Counter Drugs
In an effort to curb costs, officials with the Food and Drug Administration may soon allow patients to get certain types of medications without having to worry about obtaining a prescription. The new over the counter distribution method being considered by officials will encompass such drugs as diabetes and high blood pressure medications. The FDA… read more
DMAA Presence Prompts FDA Warning Letter to Ten Companies
The Food and Drug Administration is coming down on the makers of certain dietary supplements whose products contain an ingredient that has yet to be proven safe. Ten different manufacturers and distributors have received a warning letter from the safety agency because their products contain what’s known as dimethylamylamine, or DMAA. Also known as geranium… read more
FDA Requires New Labels on Popular Hepatitis C Treatment
A label change being issued by the Food and Drug Administration could hurt sales of a widely used Hepatitis C treatment. The drug whose label will need to be changed is called Victrelis, which the FDA approved last May. It is produced by Merck & Company. New findings have shown that Victrelis could prevent various… read more
Groups Tangle Over Proposed Individual Drug Tracking System
The potential ability of the Food and Drug Administration to track individual drug items via serial numbers might be in danger. Over the past ten years, the FDA has struggled to put together a “track and trace” plan that would put a unique serial number on every single package of medicine that’s brought to market. … read more
FDA Issues Follow Up Warning About Brilliant Blue G Drug
Reports of eye infections have prompted the Food and Drug Administration to offer a follow-up warning on a drug that they began alerting consumers about just over a month ago. On March 19, The FDA warned physicians to immediately cease using a drug known as Brilliant Blue G, which may be administered during eye surgery. … read more
FDA Warns About the Risks Fentanyl Poses to Children
The Food and Drug Administration is warning parents about the dangers that a certain pain reliever could pose to children should they come into contact with it. The item is question is called the fentanyl transdermal system, more commonly known as Duragesic. This system is a patch that for three days at a time supplies… read more
Study Shows ERs With Translators Less Likely to Make Errors
Communication is crucial when a patient is meeting with a healthcare professional to talk about their care plan. But what happens when this communication is compromised? A new study suggests that the quality of translation for non-English speaking patients in American hospitals could have a direct impact on the safety of the patient. Published in… read more
Cancer Drugs Seized After Circumventing FDA Approval Process
United States Marshals seized a number of supposed cancer curing drugs from a plant in Bogard, Missouri. The seizure was initiated following a request by the Food and Drug Administration, who investigated the plant in January following a complaint from a consumer. The manufacturer in question, Notions-N-Things Distribution, was responsible for marketing drugs that purported… read more
Unapproved Drug Baczol Ends Up on Maryland Store Shelves
Some unapproved drugs may have made their way into various retail outlets in the state of Maryland. The Baltimore Department of Health has stated that Baczol, an unapproved pharmaceutical, was being sold in at least three separate stores throughout that city and elsewhere in Maryland. A number of families reported its presence in convenience marts… read more
Pax-All Banned From Exporting Goods to America by FDA
The Food and Drug Administration has told a Canadian company that until they meet certain demands, they will be unable to pedal their goods south of the border in the United States. Pax-All Manufacturing, based out of the Canadian city of Mississauga, is the recipient of a letter from the FDA calling them out on… read more
FDA Issues Warning About Counterfeit Avastin
The Food and Drug Administration is doing its part to warn consumers of a counterfeit drug that made its way to the United States. A batch of counterfeit drugs purporting to be a popular cancer combating drug called Avastin has arrived in the US, and the FDA is worried about the drug making its way… read more