FDA & Prescription Drugs

• Dietary Supplement Recall

  Joe Saunders | November 27, 2007 3:38 PM | 0 CommentsSarasota, FL

  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

  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

  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

  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

  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

  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

  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...

• Supplement Manufacturers Will Have to Comply with More Stringent FDA Regulations

  Joe Saunders | August 29, 2007 1:44 AM | 0 CommentsSarasota, FL

  The FDA has published a final rule establishing good manufacturing requirements for the manufacturers of supplements. The rule requires that all supplement manufacturers evaluate the identity, purity, quality, strength, and composition of dietary supplements. In addition, they are required to provide accurate labeling information on all their products. The FDA ruling is supposed to protect...

• Florida Jury Awards $28.5 Million in Misfilled Prescription Lawsuit Against Walgreens

  Joe Saunders | August 21, 2007 12:09 PM | 0 CommentsSarasota, FL

  A jury in Bartow Florida awarded the family of a cancer patient $28.5 million who was given the wrong prescription, suffered a stroke, and subsequently died. According to the Associated Press article, "Beth Hippely was prescribed Warfarin, a blood thinner, in 2002 to treat breast cancer. The prescription filled at a Walgreens pharmacy was 10 times what her doctor prescribed, court documents...

• FDA Panel to Review Safety of Children's Cold Medicines

  Joe Saunders | August 16, 2007 6:46 AM | 0 CommentsSarasota, FL

  The FDA will convene a panel to review the safety and efficacy of over the counter children's cold medicines. A group of doctors are pushing the FDA to put a warning on these over the counter products that they have not been proven safe and effective for children under six years of age. The petition was filed with the FDA earlier this year after a Centers for Disease Control and Prevention...