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The New FDA
| DURACT Painkiller Posed Risk of Damage to Liver Drugmaker's lobbying won fine print instead of prominent warning December 20, 2000 |
| LOTRONEX Officer Foresaw Deadly Effects "Irritable bowel" remedy pulled after reports of serious injuries December 20, 2000 |
| POSICOR 143 Sudden Deaths Did Not Stop Approval With study results kept secret, nation got another blood-pressure drug December 20, 2000 |
| PROPULSID A Heartburn Drug, Now Linked to Children's Deaths Once evidence of harm emerged, FDA took years to withdraw approval December 20, 2000 |
| RAXAR Warning on Label Omits Deaths Heart problems were mentioned in fine print, but not key dosage data December 20, 2000 |
| REDUX Unheeded Warnings on Lethal Diet Pill Heart damage causes billions of dollars in potential legal liability December 20, 2000 |
| RELENZA Official Asks If One Day Less of Flu Is Worth It Still on the market, the drug has been linked to 22 deaths so far December 20, 2000 |
| REZULIN Fast-Track Approval and a Slow Withdrawal Diabetes drug stayed on the market a year after being listed among the most risky December 20, 2000 |
| SERZONE A Girl Is Given an Adult Medicine and She Pays a Heavy Price Company hasn't published study of effect on children December 20, 2000 |
| THALIDOMINE A Long-Feared Drug Gets the Green Light Approved to treat just leprosy, its alleged promotion as treatment for cancer draws sharp criticism December 20, 2000 |
| THE NEW FDA How Deaths Were Calculated Reports of adverse drug reactions to the Food and Drug Administration are considered by public health officials to be the most reliable early warnings of a product's danger. The reports are filed to the FDA by health professionals, consumers and drug manufacturers. The Los Angeles Times inspected all reports filed in connection with seven drugs that were approved and withdrawn since 1993. By hand and by computer, The Times counted 1,002 deaths in which the filer identified the drug as the leading suspect. Since fall 1997, this top category has been termed "primary suspect." The Times did not count any death in which the drug was identified as the "secondary suspect" or less. The methodology and results were reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an assistant professor at the University of Maryland's department of pharmacy practice and sciences. December 20, 2000 |
Copyright 2003 Los Angeles Times
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