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 […]
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 […]
The Biomet MDL (multidistrict litigation) was established for the organization and litigation of individual personal injury lawsuits against Biomet in the fall of 2012. In February of this year, the MDL contained 132 individual lawsuits. The count now stands upwards of 180 individual lawsuits, and it is still growing every […]
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. […]
According to the Centers for Disease Control and Prevention (CDC), there have been 20 patients injured by a Tennessee compounding pharmacy preparation, including 13 patients in Florida. The Main Street Family Pharmacy of Newbern, Tennessee recalled its lots of sterile product after an outbreak of skin abscesses, one of which […]
In a 1993 published study, 148 retrieved modular hip prostheses of mixed titanium cobalt and chromium were examined to determine if they had corroded while implanted in humans. Significant corrosion was observed and it didn’t matter whether the hips were metal or a combination of metal and ceramic or other […]
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 […]
A Florida compounding pharmacy will recall its sterile drug products because the Food and Drug Administration (FDA) fears they may be contaminated. The latest recall covers 91 batches of sterile product made at Balanced Solutions Compounding Pharmacy of Lake Mary, a division of Axium Healthcare Pharmacy Inc. According to a […]
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 […]
