The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]
Author: Brenda Fulmer
FDA agents have discovered that employees at the Houston office of Cetero Research tampered with records and manipulated test data. This firm has conducted research for drug companies worldwide. Chinna Pamidi, the testing facility’s president, bluntly admitted that much of the lab’s work was fraudulent, saying “You got us” when […]
Scientific studies have shown that certain types of diabetes drugs can increase the risk of pancreatitis and pancreatic cancer in users. This class of drugs, known as incretin mimetics, mimics the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. […]
Nexium – its effective marketing directly to consumers reminds Americans it is the “little purple pill” designed to treat acid reflux disease. Nexium, manufactured by AstraZeneca, is a proton pump inhibitor (PPI) prescribed to treat heartburn, acid-reflux, and inflammation of the esophagus. But plaintiffs allege that Nexium may cause a […]
The controversial cancer treatment drug Avastin (bevacizumab) has one more warning attached to it – the drug has been associated with two deaths and 52 cases of flesh-eating disease. The drug’s maker, Hoffman-LaRoche Ltd., identified the cases of necrotizing fasciitis (flesh-eating bacteria) occurring worldwide from 1997 to 2012. Both the […]
It has long been suspected that certain types of cholesterol-fighting statin drugs might present a risk for new-onset diabetes mellitus (DM) and that the risk might be dose dependent. Statins are used to prevent heart attacks and strokes by lowering cholesterol. An analysis of clinical trials involving over 113,000 patients […]
Public Broadcasting should be commended for trying to explain a very important issue that most Americans do not understand – until it happens to them. A “Need to Know” broadcast, explores the mysterious world of medical devices. Most Americans imagine their Food and Drug Administration (FDA) is protecting them from […]
The American Urogynecologic Society (AUGS) has issued a position statement that pushes back against any restrictions to ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA). The AUGS position states that it is […]
First Coast News in Jacksonville recently aired a story about four women who had the misfortune of being implanted with surgical mesh, three to treat pelvic organ prolapse or incontinence and one for hernia repair. Unfortunately, all of them had a very bad outcome. “The pain was severe enough that […]
This may be the first time that the Food and Drug Administration’s adverse event reporting database has been used to research the outcome of taking an osteoporosis drug, also known as bisphosphonates. In a published study funded by the National Institutes of Health, researchers from the Feinberg School of Medicine […]
