For the second time in the three years, independent federal investigators have determined that the U.S. Food and Drug Administration has failed to require the timely delivery of safety and efficacy data on medications the agency approved before pharmaceutical manufacturers have completed clinical trials. The FDA has also declined to take actions to remove medications…
Missoula, Montana (MT) resident Peggy L. Stevens could know by the end of this week whether the maker of the drug she took to prevent the loss of bone mass will be held liable for failing to warn prescribers and patients that the medication could actually destroy jawbones. Stevens’ suit against Novartis, which markets Zometa…
A monthlong civil trial in Philadelphia in which the mother of 3-year-old Lyam Kilker argued that taking GlaxoSmithKline antidepressant Paxil while pregnant led to her son’s heart defect ended earlier this week with a jury awarding Lyam’s family $2.5 million for past and future medical expenses. The jury determined that GSK had failed to provide…
Reading the pregnancy warnings section of the Paxil drug label is a troubling experience. For starters, the antidepressant known generically as paroxetine produces heart defects in as many of 2 percent of babies whose mothers take the drug during the first trimester. Many women taking the drug to relieve depression, anxiety, obsessive-compulsive disorder or posttraumatic…
Tuesday’s Virginian-Pilot featured a front-page story I already knew all too well. In a nutshell, the story is that no one involved in the manufacture, regulation, sale or implantation of medical devices has a complete handle on ensuring that the devices are safe. The article relates case after case in which surgeons did not get…