FDA & Prescription Drugs

• FDA Issues Health Advisory on Procrit, Epogen, and Aranesp

  Lee Coleman | November 23, 2006 6:38 AM | 0 CommentsBowling Green, KY

  The FDA issued an advisory after a research study in The New England Journal of Medicine found a higher chance of patients treated with Procrit, an erythropoiesis- stimulating agent (ESA) also known as recombinant human erythropoietin, for a combination of hospitalizations, death, and heart attack, heart failure and stroke in those with chronic kidney disease who are not on dialysis. These...

• Are Drug-Eluting Stents Lethal To Your Health?

  Lee Coleman | November 21, 2006 3:29 PM | 0 CommentsBowling Green, KY

  NBC reports today that millions of Americans could be at risk from some heart stents. The concern is devices called drug-eluting stents (DES). Approximately one million Americans a year have these implanted to treat coronary artery disease. $5 billion a year is generated by the two companies that make them. Doctors are starting to see patients with these type stents suffer from heart attacks...

• FDA Issues Tamiflu Precautions Update

  Lee Coleman | November 14, 2006 4:23 PM | 0 CommentsBowling Green, KY

  Roche Laboratories and the FDA notified healthcare professionals of new revisions to the Precautions/Neuropsychiatric Events and Patient Information sections of prescribing for Tamiflu. Postmarketing reports have been of self injury and delirium with Tamiflu use in patients with influenza. Pediatric patients were primarily the ones reported. Patients with influenza should be closely monitored...

• Recall of 11 Million Bottles of Acetaminophen

  Lee Coleman | November 10, 2006 4:05 PM | 0 CommentsBowling Green, KY

  Perrigo Co. a major manufacturer of store-brand acetaminophen recalled 11 million bottles Thursday after discovering metal fragments may contaminate some of the pills. There were no immediate reports of injuries or illness. The fragments ranged in size from microdots to portions of wire one-third of an inch long. The voluntary recall is a class II recall since it might cause a health problem or...

• Roche Diagnostics Recalls CoaguChek PT Test Strips

  Lee Coleman | October 25, 2006 6:42 AM | 0 CommentsBowling Green, KY

  The FDA and Roche Diagnostic issued a recall of CoaguChek PT test strips due to a potential for a defect that may cause falsely elevated test results. The test strips are used for people on blood thinners. Roche discovered that when insufficient active ingredient (thromboplastin) is applied to the test strip, it can cause a false elevated result. This can cause an incorrect dose of...

• Guillain Barre Syndrome and Menactra Vaccine Alert

  Lee Coleman | October 24, 2006 1:38 PM | 0 CommentsBowling Green, KY

  The FDA and CDC updated an October 2005 alert regarding reports of Guillain Barre (GBS) following the vaccine of Menactra Meningococcal Conjugate A, C, Y and W135, the manufacture is Sanofi Pasteur. In October of 2005 there were 5 reported cases of GBS following the administration of the vaccine. To date there is a total of 15 reported cases among the age groups of 11-19 year olds, and two...

• Warning On LifeScan Fake Diabetic Blood Test Strips

  Lee Coleman | October 19, 2006 6:46 AM | 0 CommentsBowling Green, KY

  The FDA is warning diabetics not to use counterfeit blood sugar test strips that were distributed nationwide. They could produce inaccurate results that could mean a patient could take either too much or not enough insulin and could lead to death or serious injury."The counterfeit test strips included those sold under the brand One Touch Basic Profile with lot numbers 272894A, 2619932 or...

• Should FDA Drop the Term "Recall" For "Safety Alert"

  Lee Coleman | October 15, 2006 6:14 AM | 0 CommentsBowling Green, KY

  Doctors are pushing the FDA to use the term 'safety alert' instead of 'recall' to warn about pacemakers and defibrillators. Citing a loss of public confidence in the safety of implantable devices. The number of implanted defibrillators in the U.S. is down 8 percent in the last 12 months according to the Prudential Equity Group. The slump is blamed on a series of recalls on several pacemakers...

• Novartis To Add Precaution to Gleevec

  Lee Coleman | October 14, 2006 6:10 AM | 0 CommentsBowling Green, KY

  Add congestive heart failure to the list of precautions for Gleevic (imitinib mesylate). Novartis Oncology said it would send letters to U.S. Physicians advising them of the possible link. Gleevec is used for chronic myeloid leukemia and gastrointestinal stromal tumors (GIST). The FDA approved Gleevec in May of 2001. Novartis said it already included data about heart failure but would add more...

• FDA Recommends Limiting Trasylol Use

  Lee Coleman | October 03, 2006 7:25 AM | 0 CommentsBowling Green, KY

  The FDA issued a new advisory stating that physicians should limit Trasylol use to those where clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risk. Trasylol has been linked with the increase in chance for death, serious kidney damage, congestive heart failure and strokes. On 9/27/06 Bayer told the FDA it had conducted an additional safety...