Apr 23, 2012 - 3:00 pm
FDA Puts 16 Drugs on Watch List
I noticed two of the 16 with some interest but please note the reassurances I'm quoting below. One of the items is gadolinium contrast dyes and a fuller story is given here
The other is Nexavar (sorafenib) (slight risk of osteonecrosis of the jaw.
The following indicates that one should not over-react:
"April 17, 2012 — The US Food and Drug Administration (FDA) today issued its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information in the agency's Adverse Event Reporting System (AERS) database during the last 3 months of 2011."
"The appearance of any drug on the AERS watch list, however, does not mean that the FDA has concluded that the drug actually poses the health risk reported through AERS, the FDA cautioned. It means only that the agency will study these drugs to determine whether there is a causal link. If the FDA establishes this link, it then would consider a regulatory response, such as gathering more information to better characterize the risk, revising the drug's label, or requiring a risk evaluation and mitigation strategy.
"Likewise, the FDA said that it is not suggesting that clinicians should stop prescribing any drugs on the watch list, or that patients should stop taking them. It advises patients with questions about watch-list drugs to discuss them with their clinician."