Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to market does nothing to assure patient safety. Specifically, the researchers were looking at how […]
Author: Brenda Fulmer
Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling. Under the current law, enacted in 1984, warning labels for particular drug formulations are created by the brand-name manufacturers, and generic manufacturers are legally prevented from altering them. […]
The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson. Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court […]
Two years ago, healthcare giant Johnson & Johnson was facing a $1.2 billion judgment after a jury determined J&J concealed the risks of its antipsychotic drug Risperdal while it aggressively and improperly marketed it off-label. At the time it was the largest state fine over the mismarketing of Risperdal and […]
A federal report issued by the Centers for Disease Control and Prevention (CDC) indicates that extensive prescribing of antibiotics is at least partially responsible for the development of C. diff (Clostridium difficile), an antibiotic-resistant bacterial infection also known as a superbug. C. diff infections affect about 250,000 patients every year […]
In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders for clients using already existing medications. Drug manufacturers fall under FDA standards and regulations, while compounding […]
Generic drugmakers are increasingly becoming more frightened of the threat of products liability lawsuits because of a proposed rule that would require them to change their labels if the company receives new safety information about the drug. These label changes would overturn a three decade old regime of prohibiting generic […]
Paxil (paroxetine) is a drug widely prescribed to treat depression. In women fighting breast cancer it is not uncommon to be prescribed Paxil. The newest research should cause health practitioners to give that practice a second thought. A team of California researchers developed a drug screening method which they applied […]
The common wisdom is that all drugs deliver a side effect as they deliver relief. The assumption has been that over-the-counter medications (OTC), used by millions of Americans, deliver fewer side effects – but that may not be true. Medications such as Aleve and Advil are getting a second review by […]
Are men and women affected the same by the same dose of a drug? It turns out that the answer to that question for some drugs is no, and the Food and Drug Administration understood that for the sleeping aid Ambien as far back as 1992. CBS’s 60 Minutes tackled the issue […]
