FDA & Prescription Drugs

• Fosamax and Jaw Death

  Joe Saunders | June 04, 2006 10:05 AM | 0 CommentsOrlando, FL

  There was an interesting article published this morning in the NY Timesregarding osteoporosis drugs and osteonecrosis. According to the article, two groups of people take the osteoporosis drugs which belong to the bisphosphonate family. The first group, those suffering from breast cancer and/or multiple myeloma whose disease has spread to the bone, receive the drug intravenously. The second...

• FDA Urges Stronger Warning for Ketek

  Joe Saunders | May 23, 2006 8:10 AM | 0 CommentsOrlando, FL

  Citing a growing number of deaths related to liver failure, the FDA has called for a stronger warning label for the antibiotic drug KetekThe FDA has received reports of 12 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to a copy of an FDA memo. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries...

• Fosamax Linked to Serious Injury

  Joe Saunders | May 22, 2006 8:55 AM | 0 CommentsOrlando, FL

  While physicians say they're rare, Fosamax users can be susceptible to "dead jaw" disease or commonly known as jaw rot. Fosamax, an osteoporosis drug belonging to the bisphosphonate family, can lead to "dead jaw" syndrome -- a painful condition that causes ulcers, tooth loss and exposed bone. But while cancer patients appear more at risk, Dr. Bruce Pihlstrom of the National Institutes of Health...

• Ketek Facing the Heat

  Joe Saunders | May 18, 2006 7:02 AM | 0 CommentsOrlando, FL

  US Senate Finance Committee Chairman Charles Grassley (R-IA) has called on the maker of Ketek, Sanofi-Aventis, to produce its investigator as part of a probe of the company's handling of the antibiotic. The letter released last night by Mr. Grassley, an Iowa Republican, is the second one he has sent to the FDA about the drug, which is made by Sanofi-Aventis SA. He told the agency he wants to...

• FDA: Bausch & Lomb Failed to Promptly Notify

  Joe Saunders | May 17, 2006 7:20 AM | 0 CommentsOrlando, FL

  The FDA said yesterday that ReNu maker Bausch & Lomb failed to promptly report 35 cases of the fusarium keratitis infection. The failure to inform the FDA within a 30 day time period is part of a larger list of 20 violations the FDA listed after inspecting the Greensville, SC plant.

• More News on Bausch & Lomb

  Joe Saunders | May 16, 2006 10:20 PM | 0 CommentsOrlando, FL

  I was quoted in today's Boston Globe as a result of Bausch & Lomb's decision to halt permanently the worldwide sales of its ReNu with MoistureLoc. As the paper stated, I think the decision confirms what we've suspected all along, namely, that the problem lies in the solution itself.

• Bausch & Lomb Hasn't Removed ReNu with MultiPlus

  Joe Saunders | May 15, 2006 9:37 AM | 0 CommentsOrlando, FL

  In spite of a sharp increase in fungal infections among users of ReNu with MultiPlus, Bausch & Lomb has not removed the eye contact solution product from store shelves. US health officials have now confirmed more than 120 cases of a potentially blinding eye infection that may be related to contact lens use.

• Vioxx Risks Continue Even After Its Use is Discontinued

  Joe Saunders | May 12, 2006 6:45 AM | 0 CommentsOrlando, FL

  A new Merck & Co. study reveals that risk for heart attacks and strokes continues even when its use is discontinued. This risk continues for a year after use. In spite of the new study, Merck says it won't change its litigation strategy. Oh well, why be confused with the facts.

• Link Between Fusarium Fungus and Bausch & Lomb Grows Stronger According to Latest CDC Data

  Joe Saunders | May 10, 2006 6:13 AM | 0 CommentsOrlando, FL

  According to the latest CDC data, the link between ReNu with Moisture Loc and the rare but dangerous fusarium keratitis fungus continues to grow sharply. The link between another ReNu product, ReNu Moisture Plus, grew, but more modestly. Of the 98 confirmed Fusarium keratitis cases for which the CDC has complete data, 93 people wore contact lenses and 59 used MoistureLoc, an increase of 27...

• Fosamax-More Harm than Cure

  Joe Saunders | May 09, 2006 6:14 AM | 0 CommentsOrlando, FL

  Fosamax, manufactured by Vioxx maker Merck & Co., is an osteoporosis drug highly touted by its manufacturer. The drug garnered $3.2 billion in 2005 sales but is now linked to osteonecrosis whereby users of Fosamax experience a rotting and death of the jaw bone. Fosamax, which contains the active compound bisphosphonate, increases bone mass and reduces the risk of fractures in postmenopausal...