Posts tagged Drug Products

• Anemia Drugs Get Black Box Warning from FDA

  Joe Saunders | March 13, 2007 10:00 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The FDA has issued a "black box" warning concerning a family of anemia drugs that have high cancer and heart risks associated with them. The news was a particularly harsh blow to Amgen. The biotech giant alone accounted for $5.3 billion in U.S. sales from its best-selling products Aranesp and Epogen in 2006. Johnson & Johnson's Procrit fetched another $2 billion in U.S. sales. Roche Group AG,...

• Attention Deficit Disorder Drug Makers Have to Warn about Side Effects

  Joe Saunders | February 21, 2007 6:24 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Pharmaceutical companies that manufacture attention deficit hyperactivity disorder will have to warn consumers of possibly dangerous side effects from the drug including mental disorders, heart problems, even sudden death. The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides

• Sanofi-Aventis Knew of Ketek Problems

  Joe Saunders | February 15, 2007 8:35 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Ann Marie Cisneros, a former employee of contractor Pharmaceutical Product Development Inc., has testified before the House Energy and Commerce Committee that the drug manufacturer knew of Ketek's problems before regulators discovered fraud. Her testimony centered around a study that demonstrated the drug's dangers prior to its US approval by the FDA in 2004.Some House Committee members lashed...

• FDA Approval Means Consumer Safety? Not So Fast

  Joe Saunders | February 14, 2007 8:20 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  There's a widespread myth that FDA approval of a new drug product means that that drug is safe for consumer use. Yet, according to a notice published Friday by the US Food and Drug Administration (FDA), from October 2005 through September 2006, companies had yet to initiate 71 percent of outstanding "post-market" safety evaluations that companies have promised to undertake for currently...

• Eli Lilly and Free Speech

  Joe Saunders | February 09, 2007 8:40 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Eli Lilly, the manufacturer of the drug Zyprexa, has aggressively fought to suppress internal company documents from seeing the light of day. The documents, which were highlighted in a December 2006 NY Times article, showed that Eli Lilly intentionally downplayed and hid Zyprexa's dangerous side effects. However, the Electronic Frontier Foundation is fighting back to allow the general public...

• Certain Antacids Linked to Hip Ailments

  Joe Saunders | January 02, 2007 9:45 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  A recent medical study has found a link between some popular over-the-counter antacids such as Prevacid, Prilosec, and Nexium and hip fractures. The greatest danger was found in those who took the drugs in large quantities for a year or more.

• Dangers of Zyprexa

  Joe Saunders | December 03, 2006 7:39 PM | 1 CommentSarasota, FL Category: FDA & Prescription Drugs
  

  Zyprexa, an antipsychotic drug used to treat schizophrenia, has been linked to diabetes, diabetic coma, even death. The FDA issued a black box warning a few years ago concerning these dangerous side effects.

• Coumadin Gets Tougher Warning Label

  Joe Saunders | October 10, 2006 10:43 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Bristol Myers Squibb, the manufacturer of the blood thinning drug Coumadin, has strengthened its warning label concerning the dangers of potentially fatal bleeding. Coumadin, known generically as Warfarin, had previously cited a "risk of hemorrhage" and wasn't highlighted in a black box.

• Glaxo Drug Lamictal Linked to Birth Defects

  Joe Saunders | October 03, 2006 7:54 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  Lamictal, the Glaxo Smith Kline drug is used to treat epilepsy and bipolar disorder, has been linked to certain birth defects including cleft palate or lip exposed to the drug during pregnancy. According to a Wall St. Journal article " After discussions with Health Canada in August, Glaxo said the cleft-palate deformity was detected at "an elevated rate" in infants whose mothers took the drug...

• Concerns Over Acne Drug Acutane Continue

  Joe Saunders | August 22, 2006 9:02 AM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  According to a recent study, Acutane can cause more than birth defects. The use of the acne drug can potentially cause heart and liver problems as well. The study, published in the Archives of Dermatology, pointed to test results from a 7 year study of patients ranging in age from 13 to 50. The tests found higher than normal cholesterol and abnormal liver function results.