New FDA 2010 Safety ReviewsThe FDA just announced that they will be conducting more safety reviews on a number of drugs based upon potential signals of serious risks/new safety information that were identified for these products during the period April - June 2009 in the AERS database. There were two separate lists identified some products relevant to Transplant and Psoriasis/RA drug products which are relevant. These are on top of the safety issues previously identified previously (black label drug warnings requested by FDA etc) , so longer term usage trends information are showing additional risk factor signals.
So when does the risk outweigh the drug benefit, for each indication Psoriasis, Transplant, RA etc? Is it time for drugs like Voclosporin which are designed with an enhanced safety profile or wider therapeutic window to get more prominence in indications like Psoriasis where less risk is tolerated?
Tumor Necrosis Factor (TNF) Blockers:
Potential Signal of a Serious Risk/New Safety Information is: Demyelinating neuropathy
The FDA did not name specific TNF blockers, but the drug include Amgen (
AMGN.O) and Pfizer's (
PFE.N) Enbrel, and Abbott Laboratories Inc's (
ABT.N) Humira.
Immunosuppressants (transplant):
Potential Signal of a Serious Risk/New Safety Information is: BK virus nephropathy
- sirolimus marketed as Rapamune
- cyclosporine marketed as Sandimmune and generics
- cyclosporine modified marketed as Neoral and generics
- mycophenolate mofetil marketed as Cellcept and generics
- mycophenolic acid marketed as Myfortic
Sirolimus (Rapamune)
Progressive multifocal leukoencephalopathy (PML)
Associated announcements:
https://uk.reuters.com/article/idUKN1719273020100218
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm199543.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm199544.htm
Also there was a report published by BioTrends outlining Stelara impresses with efficacy but Dermatologists may be concerned with long-term risk usage.
https://www.prnewswire.com/news-releases/stelara-impresses-with-efficacy-data-and-dosing-convenience-but-safety-concerns-likely-to-impact-near-term-uptake-84688452.html
Other drugs previously associated with PML risks were also Rituxan,Tysabri, Cellcept, Myfortic, Prograf & Raptiva which was withdrawn from the market.