Posts tagged Drug Products

• Congress Starts Asking Questions About Dr. Jarvik

  Joe Saunders | January 08, 2008 11:36 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Dr. Robert Jarvik became known as the maker of the world's first artificial heart in the 1980's. Most recently, his face and name are splashed in tv and print media ads pitching Pfizer's cholesterol drug Lipitor. The marketing campaign is so often used that Congress has started asking Pfizer questions about Dr. Jarvik's qualifications to pitch a cholesterol drug. The Wall St. Journal...

• Older Patients Who Take Avandia Have Higher Risk of Heart Attacks

  Joe Saunders | December 13, 2007 11:33 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  According to an article published in the Journal of the American Medical Association older people who suffer from diabetes and take Avandia as part of their treatment regimen are 60% increased risk of heart failure, a 40% increased risk of heart attack, and a 30% increased risk of death. This is obviously not good news for Glaxo Smith Kline, the manufacturer of Avandia. Avandia is a...

• Genentech's Move to Restrict Use of Cheaper Avastin Leads to Probe

  Joe Saunders | December 03, 2007 9:30 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Genentech, the maker of Avastin, has sought to restrict access to its cheaper drug Avastin so that health officials will use a more expensive brand has lead to Congressional criticism. The restriction on the eye disease drug has led one US senator to write letters to the Centers for Medicare and Medicaid and the FDA inquiring as to the propriety of Genentech's actions. Senator Kohl of...

• Dietary Supplement Recall

  Joe Saunders | November 27, 2007 3:38 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Bodee LLC has issued a voluntary recall of all its Encore dietary supplements after the FDA determined that a chemical analyis of the supplement contained harmful, undeclared ingredients. The FDA analysis showed that Encore Tabs contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close...

• Senate Bill Would Allow FDA Monitoring of Over the Counter Drug Ads

  Joe Saunders | November 13, 2007 8:18 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  A bill introduced by Senators Henry Waxman of California and Ted Kennedy of Massachusetts would give the FDA regulatory authority concerning ads for over the counter drugs. The bill comes in the wake of an FDA advisory about banning cold medicines for children under the age of 6. The new bill would give the federal agency power to impose monetary fines on advertisers. Presently, over the...

• Novartis Chief Executive Says FDA Succumbing to Political Pressure in its Attempt to Increase Drug Safety

  Joe Saunders | October 09, 2007 5:09 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  During the three day Clinton Global Initiative, Novartis Chief Executive Dan Vasella said that the FDA was buckling under political pressure to monitor the safety and efficacy of new pharmaceuticals. HIs comments were made in the wake of rising awareness of overly aggressive marketing tacticts by pharmaceutical companies at the expense of consumer safety. Two Novartis drugs, Prexige and Galvus...

• FDA Cites Cold Medicine Dangers for Children

  Joe Saunders | September 29, 2007 9:26 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Cold and cough medicines purchased over the counter for children under six years of age can cause serious side effects, including death, concluded an FDA analysis of the safety of children's cold and cough medicines. The FDA has had 54 reports of children's death as a result of using decongesants containing pseudoephedrine, phenylephrine and ephedrine. The FDA has told companies marketing...

• FDA Warning Issued for Pain Drug Fentora

  Joe Saunders | September 27, 2007 10:45 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Fentora, used to treat pain in cancer patients, has drawn an FDA warning as a result of deaths in patients who were given the improper dosage or Fentora was incorrectly substituted as a pain management pharmaceutical. The FDA warning stated that Fentora should not be used in cancer patients who are unable to tolerate other opioiddrugs. Fentora was approved by the FDA last year for cancer...

• Congress Gives FDA More Power to Monitor Drug Safety

  Joe Saunders | September 21, 2007 8:18 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Congress has passed legislation giving the FDA new powers of oversight concerning the pharmaceutical industry including more authority to require changes to drug labels, demand additional safety studies and limit the distribution of medications when safety concerns arise. The new legislation includes an interesting twist in that it may limit protection of pharmaceutical companies for drugs that...

• Ketek Significantly Increases Risk of Liver Disease

  Joe Saunders | September 13, 2007 5:43 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Ketek, an antibiotic used for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, tonsillitis, or pharyngitis, has been shown to cause severe liver injury. Health Canada, in its September 2007 edition, has documented the risk of liver damage for users of the drug. The FDA should recall Ketek as a dangerous drug. Its risks significantly outweigh its...