FDA & Prescription Drugs | InjuryBoard Las Vegas

FDA adds black box warning to conventional antipsychotics under new found power of Food and Drug Amendments Act.

Who is monitoring drug and medical device safety? If the FDA is understaffed and underfunded will the Sentinel Initiative work?

After a few years in this business of representing patients/clients who have been injured by defective drugs, it appears that:1. The FDA doesn't protect consumers, though it might try2. All should know that the FDA doesn't test drugs3. The drug companies are in it for profit first, helping people second (no surprise)4. You shouldn't take any new drug until it has been out on the market...

Yesterday, I commented on the FDA's difficulties in meeting its mandate as described in the FDA Report on Science and Technology published on December 3, 2007, by the FDA Science Board Advisory Committee. Despite the severe limitations on the FDA's abilities set forth in that report, the FDA is forging ahead with proposed "Guidance for Industry" which would allow drug companies to distribute...

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlhttp://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlhttp://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlAccording to an FDA Report on Science and Technology published on December 3, 2007, the FDA is essentially not able to fulfill its mandate of assuring the safety of drugs. ...

Consideration of the Vioxx settlement and whether one is going to participate is going to take at least a 3-4 weeks. There are many questions still to answer before an attorney can advise his or her clients if the Settlement is best for him or her.The Settlement Agreement is set up so that each individual's case is assessed separately. That is fair. A young person (in 40's say) with few...

Adverse drug effects reported to the FDA over the last decade have more than doubled, according to a new study. Deaths associated with adverse effects have also more than doubled."A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of...

Four fatalities have been linked to the recently approved drug, Fentora, a powerful painkiller intended for cancer pain, according to Cephalon Inc., the drug manufacturer Thursday.It appears all four deaths are the result of improper use of the drug, Fentora, manufacturer Cephalon Inc. said. The drug was approved in September by the FDA for use by cancer patients. Fentora contains fentanyl, a...

The Food and Drug Administration (FDA) is aware of a safety issue regarding the drug rosiglitazone maleate, marketed under the brand name Avandia. The drug is for type 2 diabetes.Safety data analysis of controlled clinical trials shows a significant increase in the risk of heart attack and heart related health issues and deaths in patients that take Avandia.Published and unpublished data from...

Permax, a drug used by thousands of patients that suffer with Parkinson's disease, is being recalled and pulled from the market due to reports of heart valve damage caused by the drug.The Food and Drug Administration (FDA) says that pergolide, sold under the name Permax, is also available in generic form is being recalled at the agency's request.An FDA official says other drugs can act as a...

The FDA has issued a public health advisory to notify health care professionals and patients that the sponsor of Zelnorm, Novartis Pharmaceuticals Corporation, agreed to take Zelnorm off the market. The Zelnorm recall is due to new safety analysis that found a higher chance of heart attack; stroke and chest pain can become a heart attack in patients treated with Zelnorm. Compared to those...

On Friday, the FDA issued a public health advisory to warn patients and care providers that the use of common anemia drugs can increase a risk of death and other serious problems in kidney disease or cancer.The drugs that are causing concern are Epogen, Aranesp and Procrit, all of which are erythropoiesis-stimulating agents. Genetically engineered, these drugs are versions of a natural protein...

Bayer HealthCare has announced they are discontinuing three clinical trials of the drug Trasylol, citing recent FDA-approved label changes. Bayer was hoping to expand the approved usage of the drug, is currently approved for use in the course of coronary artery bypass graft surgery.The trials were to investigate the safety and efficacy of Trasylol (aprotinin injection) in adults undergoing...

Former vice president of two Johnson & Johnson subsidiaries claims he was fired for seeking recalls of many faulty products, including the Ortho Evra birth control patch - subject of at least 1,000 product liability suits.Joel S. Lippmann, 52, of Warren, started working for J&J in 1990 and worked his way up to vice president of clinical trials for Ortho-McNeil Pharmaceutical Inc., which makes...

Sanofi-Aventis SA today, told U.S. regulators that its Ketek antibiotic is an essential treatment for bacterial infections, although the drug has been linked to liver failure and death in some patients.Two Food and Drug Administration committees are hosting public meetings over the next two days to discuss whether Ketek, used to fight pneumonia, bronchitis and sinusitis, is safe enough to remain...