Following reports of adverse reactions to the drug and reports it may spread from the site of injection, the FDA has called on manufacturers to include a boxed warning on the label and a Risk Evaluation and Mitigation Strategy (REMS).
Those who administer the injections are advised by the FDA to alert patients and caregivers of possible side effects, be aware these have been reported both very soon after treatment and up to several weeks following injections.
The regulatory agency invites health care professionals and consumers to report adverse effects with the MedWatch program.
