FDA Could Approve Xarelto Despite Internal Bleeding Risk
A drug that could help prevent blood clots in certain persons is going to be reviewed on Wednesday, and even though the Food and Drug Administration is cautiously optimistic about its approval, officials still have worries. Johnson & Johnson is the maker of the drug, which is called Xarelto. The drug is already on the… read more
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 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
Perfect Image Solutions Recalls Unapproved New Drugs
According to news sources, a recall has been issued for several topical Perfect Image Solutions products after they were deemed as “unapproved new drugs” by the Food and Drug Administration due to the potential health hazards they pose to consumers. Some of the recalled products include 10-15 percent Minoxidil, which can be reportedly unsafe due… read more
FDA Advice on Stem Cell Therapies
According to news sources, a patients hope to find a cure that may not yet exist could potentially entice them to believe untrue stem cell claims made by unscrupulous providers, the Food and Drug Administration warns. Stem cells behave like the body’s “master cells”, with enormous potential in treating medical conditions with no existing treatments… read more
FDA: Avastin Not For Breast Cancer Treatment
According to news sources, the Food and Drug Administration has recently ruled that the popular drug Avastin should not be used to treat advanced breast cancer as the danger of potential side effects outweigh the benefits the drug offers. The drug will remain in the market nonetheless, as it is used to treat colon cancer… read more
FDA Attempts To Make Reusable Medical Devices Safer
According to news sources, The U.S. Food and Drug Administration is seeking to make reusable medical devices safer by working with organizations, hospitals and government agencies to ensure that they are cleaned and disinfected properly. The FDA is involved in an ongoing effort to ensure the safety of reusable medical devices, which can reduce the… read more
HIV Drug Isentress Gains Expanded FDA Approval
According to news sources, the drug Isentress (raitegravir) has been given expanded approval by The Food and Drug Administration to begin being used by those between 2-18 years of age. The drug was first approved for adult usage back in October 2007 under the agency’s accelerated approval program, which aims to make the introduction of… read more
Sandwich Maker Shuts Down Production Due To Health Risks
According to news sources, the Food and Drug Administration has announced that a Chicago based ready-to-eat sandwich maker has shut down manufacturing after a repeated history of violations and a reported Listeria outbreak. The company, Triple A Services Inc., has announced the closure of of the manufacturing facility after agreeing to stop producing and distributing… read more
FDA Safety Warning For Multaq, A Heart Rhythm Drug
According to news sources, the drug Multaq is getting a new safety warning after a study found increased risks of heart attack, stroke and death associated with the drug with a subset of patients that took part in the study. The heart rhythm drug controls the heart’s chambers by allowing them to pump in sync… read more
Ephedrine Dietary Supplements Seized By U.S Marshals
According to news sources, raw materials for dietary supplements containing ephedrine alkaloids have been seized by U.S Marshals directed by the Food and Drug Administration in an attempt to reign in on the banned material. The seizure of the raw materials imported by Infinity Marketing Group, Inc. totals a value of about $70,000. The FDA… read more
Children Mechanical Cardiac Assist Device Approved By FDA
According to news sources, the Food and Drug Administration has recently approved a medical device to help children suffering from heart failure that will reportedly to stay alive while a heart transplant donor can be found. The device us called EXCOR Pediatric System and was developed by Berlin Heart for the purpose of fitting the… read more
