FDA & Prescription Drugs

• Advice on Avoiding Bad Prescription Drugs

  Stewart White | February 16, 2008 4:16 PM | 0 CommentsLas Vegas, NV

  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...

• Avandia Recall Information

  Chrissie Cole | May 28, 2007 11:45 PM | 0 CommentsLas Vegas, NV

  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in the risk of heart attack and heart related health issues and deaths in patients that take Avandia.Published and unpublished data from...

• Anemia Drugs Pose Health Risk

  Christina Cole | March 09, 2007 2:33 PM | 0 CommentsLas Vegas, NV

  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...

• Trasylol Clinical Trials Halted

  Christina Cole | February 02, 2007 7:29 PM | 0 CommentsLas Vegas, NV

  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...

• Sanofi-Aventis Defends Ketek's Safety to U.S. Panels

  Christina Cole | December 15, 2006 5:09 AM | 0 CommentsLas Vegas, NV

  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...

• FDA Not Too Underfunded to Screw Consumers

  Peter Wetherall | December 04, 2007 5:05 AM | 0 CommentsLas Vegas, NV

  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...

• Reports of Adverse Drug Effects Have Doubled Over the Last Decade

  Chrissie Cole | September 26, 2007 3:25 PM | 0 CommentsLas Vegas, NV

  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...

• Fentora Painkiller Tied to Deaths

  Chrissie Cole | September 14, 2007 6:34 AM | 0 CommentsLas Vegas, NV

  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...

• Hepatotoxicity: 35 Drug Products Require New Warnings

  Peter Wetherall | August 14, 2008 4:16 PM | 0 CommentsLas Vegas, NV

  The FDA recently posted a list of 35 drugs that required safety labeling changes.http://www.fda.gov/medwatch/safety/2008/jul08_quickview.htm  Readers know recent blogs discuss several unsafe drugs,...

• FDA's Pursuit of Drug Safety an Underfunded Farce

  Peter Wetherall | December 04, 2007 4:33 AM | 0 CommentsLas Vegas, NV

  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. ...