The FDA released a watch list that includes 19 drugs or drug classes, seven of which are cancer therapies, which may have serious risks or have new safety information. The list is derived from FAERS.
Drugs relevant to hematology and oncology and their associated risks include:
- alemtuzumab for acute acalculous cholecystitis
- imatinib mesylate for decline in renal function
- pembrolizumab for Stevens-Johnson syndrome and toxic epidermal necrolysis and complications of allogeneic hematopoietic cell transplantation (alloHCT)
- nivolumab for complications of alloHCT
- pomalidomide for ischemic colitis
The FDA noted that a drug’s appearance on a quarterly FAERS watch list does not mean that the agency has determined a causal relationship between that product and the AE, but it does indicate the need for further study. If the FDA determines that there is a causal link between the product and the AE, the agency can collect more data to better describe the risk, change the drug’s label, order a risk evaluation and mitigation strategy, or pull the product from the market.
Source: U.S. Food and Drug Administration watch list, October 6, 2017.