The Food and Drug Administration made a mistake in approving a knee implant against the advice of its scientific reviewers. It has now admitted that it shouldn’t have approved the device. The announcement comes a year after the agency first acknowledged that is decision to approve the Menaflex implant, made by ReGen Biologics, was influenced [...]
The company’s chief executive says that Johnson & Johnson disappointed consumers when it recalled millions of bottles of popular children’s medicines. William Weldon admitted that the company had let the public down, saying: We let the public down. We did not maintain our high quality standards, and as a result, children do not have [...]
The U.S. Food and Drug Administration has warned doctors and patients about an increased risk of thigh fractures with a widely-used group of bone-strengthening drugs. The agency said patients taking bisphosphonate drugs such as Fosamax and Boniva appear more likely to suffer a rare type of fracture of the femur. The factures occurred just below [...]
Source: US Food & Drug Administration Prescribing physicians and pharmacists should be alert for potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. Why? Because despite the fact that we were supposed to have been a metric society about 30 years ago, we aren't. What does that have to do with anything? Quite a bit [...]
Source: US Food & Drug Administration; BBC Health The US FDA has announced that all drugs in the bisphosphonate class (Fosomax, Boniva, Actonel, Reclast) which are designed to treat osteoporosis, a condition which makes bones brittle, may actually cause a fracture of the thigh bone. Let's say that one more time, drugs which are currently [...]
Source: Heartwire; European Society of Cardiology I like to include this in my, "See, I'm not crazy after all" file. A Danish population study (The Danes are usually well-ahead of the U.S. on these trends) presented last week at the European Society of Cardiology 2010 Congress points to an alarmingly high risk of stroke in [...]
Source: Wall Street Journal You may recall a prior blog post on this site, "All your doctors are belong to us" in which mention was made of class action litigation driving drug manufacturer, Eli Lilly to disclose physicians who receive money from Lilly. http://www.lillyfacultyregistry.com/lilly-registry-report.jsp. You may further recall that just in time for Halloween, I [...]
Source: US FDA; Wall Street Journal You will recall that in October of 2009, we reported on the FDA's investigation of Cedars-Sinai Hospital in LA and documented overdosing of radiation during CT scans. And you may further recall that I said this was likely an emerging trend. Well, you will be shocked to know that [...]
The acne "cure" so many teens are familiar with is being pulled from the market. Roche Holding, AG, has taken Accutane off of the US Market following 6 adverse (that means bad for Roche) jury awards of over $33 million for allegations that it caused bowel disease in users. Specifically ulcerative colitis and Chron's Disease. [...]
Okay, some of you may not get that reference. Too bad. Google is your friend. As part of a class action lawsuit settlement (wonder if they would have been as forthcoming without the lawsuit), Eli Lilly has started to disclose physicians who have received payment from the drug company. Is your doctor among them? http://www.lillyfacultyregistry.com/lilly-registry-report.jsp [...]