Posts tagged Drug Products

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

  Joe Saunders | August 29, 2007 1:44 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  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 Category: FDA & Prescription Drugs
  

  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 Category: FDA & Prescription Drugs
  

  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...

• Novartis Pulls Pain Relief Drug from Australian Market

  Joe Saunders | August 14, 2007 7:32 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  After two people died, Novartis AG has pulled its pain relief drug Prexige from the market in Australia. According to a story published in the Wall St. Journal, "Australia's Therapeutic Goods Administration said it had received eight reports of serious liver reactions in patients taking the drug. "It seems that the longer people are on the medicine, the greater the chance of liver injury," its...

• Oxycontin Manufacturer Ordered to Pay Fine for Misleading Public

  Joe Saunders | July 20, 2007 8:38 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Purdue Pharma L.P., the manufacturer of the popular Oxycontin, has been ordered to pay the stiff penalty of $634.5 million fine for misleading the public regarding the drug's addiction risk. In a Boston Globe article,the drug is "designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected. From 1996 to...

• Zyprexa Manufacturer May Face More Legal Woes

  Joe Saunders | July 02, 2007 2:47 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Eli Lilly, the manufacturer of the drug Zyprexa, may face more legal troubles after the FDA told the company it would delay the approval of its new drug Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac. Zyprexa has...

• Amgen Faces More Safety Questions

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

  Amgen was a rising star in the pharmaceutical industry until serious questions arose about the safety of two of its biggest selling drugs which treat anemia in cancer and kidney-failure patients. A black-box warning placed March 9 on the labels of those and other anemia drugs urges doctors to use the smallest possible dose of the drugs. The two anemia drugs, Epogen and Aranesp make up almost...

• Heart Valve Injury Leads Valeant to Pull Permax from Market

  Joe Saunders | March 30, 2007 12:49 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Two studies linking the Parkinson's drug Permax with heart valve damage have resulted in Valeant Pharmaceuticals International pulling the once popular drug from the market. The FDA had asked the drug manufacturer to discontinue marketing the product after the heart valve injury studies. If you are taking or have taken Permax for Parkinson's disease, you should consult your physician for...

• Parkinson's Drug Permax Found to Increase Cardiac Valve Problems

  Joe Saunders | March 17, 2007 10:53 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The journal Drug Injury Watch reports that "new study published in the March 2007 issue of the medical journal Archives of Neurology provides further support to the theory that the long-term use of Permax (pergolide) for Parkinson's disease increases the risk of valvulopathy, primarily cardiac valve regurgitation. In comparison, the same study found that Mirapex (pramipexole) and Requip...

• FDA Warns Sleep Aid Manufacturers

  Joe Saunders | March 15, 2007 9:11 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The FDA has told manufacturers of certain sleep aids that they must put stronger warnings on their labels in order to advise consumers of the possible side effects. The products include the popular Lunesta and Ambien.