The FDA has issued an alert to healthcare professionals about the risk of adverse skin reactions for individuals who receive an injection of Vivitrol, a drug given to treat alcohol dependence. Continued
All Posts Tagged With: "FDA"
FDA Issues Reminder Novantrone Warning
The FDA issued a health alert yesterday to neurological and oncological healthcare providers who use Novantrone and generic mitoxantrone. The statement was sent as a reminder about previous recommendations which have been issued about the safe use of the drug. Continued
FDA Warns of Possible Malfunctions for Pacemakers, Defibrillators and other Electronic Devices Caused by CT Scans
On Monday, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification to healthcare professionals warning that x-rays used during CT Scans could cause problems for some people with electronic medical devices such as pacemakers, defibrillators, neurostimulators and drug infusion pumps. The FDA issued recommendations to help reduce the risk after receiving reports of malfunction and identifying other potential problems that could be caused by the x-rays. Continued
FDA Panel Recommends Against Epilepsy Drug Black Box Warning
The U.S. Food and Drug Administration (FDA) convened an advisory panel last week to evaluate the risk of suicide associated with epilepsy drugs, and to make recommendations about what regulatory actions should be taken to protect consumers. Although FDA officials indicated they believe a “black box” warning should be placed on the drugs, the independent panel recommended against such a strong warning at a hearing on July 10, 2008. Continued
Public Citizen Urges FDA to Issue Darvon and Darvocet Recall
On Friday, the consumer interest group Public Citizen filed a federal lawsuit against the U.S. Food and Drug Administration (FDA) in Washington, D.C. The lawsuit alleges that the agency violated the law by failing to act on a petition filed in 2006, which urged the removal of Darvocet, Darvon and generic propoxyphene drugs from the market because they have been associated with over 2,000 accidental deaths, are physically addictive and are no more effective than other safer painkillers. Continued
(VIP) Viril-Ity-Power Tabs Recall: ED Dietary Supplement
On May 30, 2008, the FDA announced a nationwide recall for Viril-Ity Power (VIP) Tablets. The dietary supplement is sold over-the-counter for erectile dysfunction and sexual enhancement. The tablets contain an undeclared ingredient, hydroxyhomosildenafil, which is an analog of the active chemical ingredient in Viagra. Continued
Xiadafil VIP Tabs Recall
On Tuesday, the FDA issued an alert warning consumers not to buy or use Xiadafil VIP Tablets, which are sold as a dietary supplement over the internet for sexual enhancement and to treat erectile dysfunction. The FDA has requested that the manufacturer, SEI Pharmaceuticals, issue a Xiadafil VIP Tabs recall because the tablets contain an undeclared ingredient which could impact the users blood pressure and lead to potentially life-threatening injuries. Continued
Mommy’s Bliss Nipple Cream Recall
Mommy’s Bliss Nipple Cream has been removed from the market because certain ingredients contained in the product could be harmful to nursing infants. On Friday, the FDA issued a warning for mothers not to use the nipple cream and to seek immediate medical care if their baby experiences problems such as respiratory distress, vomiting or diarrhea. Continued
FDA Warns of Myfortic and CellCept Birth Defect Risks
On Friday, the FDA posted an alert on their website to provide additional information to doctors about the possible risk of miscarriages and birth defects associated with the use of CellCept and Myfortic during pregnancy. A black box warning was added to the organ transplant medications in November 2007, but the FDA issued a second alert last week since the drugs are often prescribed “off-label” for unapproved uses, such as treating lupus, and many doctors remain unaware of the danger of fetal injury. Continued
FDA is Continuing to Review Safety Concerns About Maxipime (cefepime) Death Risk
On Wednesday, the FDA provided an update to an early communication issued last November about concerns that an injectable antibiotic known as Maxipime (cefepime), may increase the risk of death when compared to similar drugs. Although the FDA originally indicated that the preliminary review would take about four months, they have indicated that the review of safety data is still ongoing. Continued
