Posts tagged Drug Products

• Merck Hit With $50 Million Vioxx Verdict

  Joe Saunders | August 17, 2006 3:34 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  A New Orleans jury found for a heart attack victim in the latest round of Vioxx court battles. The jury awarded Gerald Barnett, a 62-year-old retired FBI agent $50,000,000 in compensatory damages. Mr. Barnett took Vioxx for 31 months and had had a quintuple bypass at the age of 58. The jury found that Merck, the maker of Vioxx, had failed to adequately warn doctors about the drug's potential...

• Infant Tylenol Manufacturer to Pay $5 million

  Joe Saunders | August 16, 2006 9:37 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  A Philadelphia jury has returned a $5,000,000 judgement against the manufacture of Tylenol for infants. McNeill-PPC was slapped with the verdict for failure to warn of overdose dangers that caused liver damage and death to a 5 year old. Infant Tylenol is more potent than children's Tylenol and the label did not sufficiently advise of the drug's concentrated formula.

• FDA Asked to Improve Oversight of Drug Studies

  Joe Saunders | July 10, 2006 8:01 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The Department of Health and Human Services has issued a plea to the FDA to tighten its monitoring of promised studies by drug companies. According to a Wall St. Journal story, "The Food and Drug Administration doesn't know the status of many postapproval studies promised by drug makers and doesn't make tracking them a top priority, a report released Friday said.The inspector general at the...

• Increased Fungal Risk Confirmed with ReNu Product

  Joe Saunders | May 22, 2006 9:01 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  In the same week that Bausch & Lomb decided to permanently withdraw its ReNu with MoistureLoc contact lens solution from shelves worldwide, the Center for Disease Control and Prevention (CDC) confirmed on Friday (May 19) that the product was the cause of an increased incidence of Fusarium keratitis.

• American Medical Association Missed Vioxx Warnings 5 Years Ago

  Joe Saunders | May 16, 2006 10:35 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  In 2001, the American Medical Association missed an opportunity to warn the public about the potential danger of Merck's drug Vioxx, according to a front page story in the Wall St. Journal. According to the Journal article, "Dr. Hrachovec had been reviewing data on a Food and Drug Administration Web site indicating that patients in a Vioxx clinical trial had suffered more heart attacks than the...

• Bausch & Lomb Recalls ReNu with MoistureLoc Worldwide

  Joe Saunders | May 15, 2006 9:41 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Facing intense pressure due to the fusarium keratitis outbreak, Bausch & Lomb has made a worldwide recall of its eye contact solution product ReNu with MoistureLoc. The crisis began more than 6 weeks ago and initially Bausch & Lomb told stores to stop selling the product. Eventually, the product was removed from store shelves.

• Link Between Fusarium and Bausch & Lomb Grows

  Joe Saunders | May 10, 2006 6:18 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  According to a CDC released yesterday, the link between the eye fungus fusarium keratitis and Bausch & Lomb products continues to grow. Fungal keratitis is a painful inflammation of the cornea that can, in some cases, lead to blindness. The infection, caused by a fungus found in the environment, can appear as a result of eye injury, improper use of contact lenses or contaminated contact-lens...

• China FDA Removes ReNu from Stores

  Joe Saunders | May 08, 2006 9:52 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The Shanghai Food and Drug Administration has removed all US manufactured ReNu with MoistureLoc products from store shelves. Only about 2% of the ReNu product is made in the US. The majority of the product is made domestically. Bausch & Lomb has tried to assuage Chinese consumers that since the bulk of the ReNu they use is produced in China, it's safe for use.

• Fusarium Fungus Cases Continue to Rise

  Joe Saunders | May 07, 2006 9:54 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Fusarium Keratitis, the rare but dangerous fungus, continues to rise among contact lens wearers. However, the source of the fungus remains a mystery. The proportion of patients who said they used MoistureLoc has since held steady at around 50 percent to 60 percent of the 102 cases confirmed so far, the CDC said.

• More Tears for Bausch & Lomb

  Joe Saunders | May 04, 2006 6:59 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  In a company press statement issued in the middle of the night, Bausch & Lomb now reveal that additional cases of fusarium keratitis have been linked to the company's ReNu products. According to a Market Watch report, "In an overnight release, Bausch & Lomb said "that a review by the U.S. Centers for Disease Control and Prevention had found reported cases of fungal keratitis among contact-lens...