Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval. Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months. Below are […]
Author: Cal Warriner
The Institute of Medicine (IOM) is taking the U.S. Food and Drug Administration (FDA) to task. In a new report, the IOM says the FDA should conduct more regular reviews of drugs to better catch and track safety issues. In order to better inform patients and the doctors who treat […]
The Top Ten of anything usually designates the ‘best’ but not in this case. An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 […]
The U.S. Food and Drug Administration (FDA) wants to remind the public what a good job it’s been doing in monitoring drugs both before and after they are marketed. In a report issued over the weekend, April 21, “Advances in FDA’s Safety Program for Marketed Drugs,” the agency pats itself […]
We now have a better idea of how one synthetic mesh medical device maker, American Medical Systems, Inc., plans to defend itself against the 318 lawsuits that have been consolidated in the Southern District of West Virginia before The Honorable Joseph R. Goodwin. In a Position Statement, issued and filed […]
The “antipsychotic” class of drugs is distributed liberally in nursing homes. Antipsychotics including Risperdal, Seroquel, Zyprexa, and Abilify, are frequently given to the elderly who are suffering from dementia so they are easier to control. It’s a handy tool in a nursing home that is understaffed and needs to find […]
The Mentor ObTape Sling is a transobturator vaginal sling, which was manufacturer by Mentor Corporation and was implanted in thousands of women to treat Stress Urinary Incontinence (SUI). Mentor’s ObTape replaced Mentor’s Uratape product. Uratape performed so poorly that Mentor quit selling it after an embarrassingly short time on the […]
We hear from them every day – consumers who trust and believe their doctor only to find out things like what Consumer Reports (CR) investigates in its May issue. Surprisingly, the majority of medical devices never have to pass through any sort of safety and efficacy standard with the Food […]
Johnson & Johnson (J&J) rarely responds to negative news, which it’s been experiencing a lot of lately, usually relying on the news cycles to wash away unfavorable reports. But in an unusual move, a J&J spokesman recently did defend the company from the latest blow – that the health care […]
If I sell you a product and make a profit from selling that product; do I owe a duty to you for the reasonable safety of that product? Most reasonable people would agree that a company should not be permitted to simply ignore the safety of products it profits from […]
