FDA & Prescription Drugs

• FDA Approval Means Consumer Safety? Not So Fast

  Joe Saunders | February 14, 2007 8:20 AM | 0 CommentsSarasota, FL

  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

  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

  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

  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

  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

  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

  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.

• Merck Hit With $50 Million Vioxx Verdict

  Joe Saunders | August 17, 2006 3:34 PM | 0 CommentsSarasota, FL

  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

  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

  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...