According to a new study from the U.S. Food and Drug Administration, only half of drug labels include adequate information on the safety, effectiveness, and dosage for children. Overall, researchers found that 54% of all drug labels did not include useful pediatric information. When only considering medication that is relevant […]
Category: Articles
Consumers Union has posted an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?” Sounds like the answer should be a resounding […]
By now you’ve heard about the bisphosphonates that are typically prescribed when a woman or man experiences the bone-thinning disease of osteoporosis or osteopenia. They are known by their commercial names of Boniva, Fosamax, Actonel, Reclast and were introduced in the mid-1990s. Introduced in the mid 1990s, a recent New […]
A study published in the New England Journal of Medicine on May 17, 2012, suggests that the popular antibiotic azithromycin may increase the risk of sudden cardiovascular death, especially among patients who are already at risk for cardiovascular disease. Different patient groups were treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), […]
In an unexpected move, the Department of Justice has suspended its four-year civil and criminal investigation into allegations of off-label marketing by Medtronic Inc. concerning its Infuse bone graft product. No charges have been issued and there was no settlement reached after the company was notified by the U.S. Attorney […]
The U.S. Food and Drug Administration (FDA) announced on Wednesday, May 9, that patients taking the osteoporosis drug, Fosamax, or any of the bone-building class of drugs known as bisphosphonates, should be reevaluated every three to five years to determine if it is safe for them to remain on the […]
If you blinked you may have missed this news item but it’s important to understand how government inaction hurts its citizens and this is a prime example. On Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds […]
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 […]
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 […]
