If you participate in any of the FOP community’s online support groups you’ve heard discussions about off-label treatments for FOP. The International Clinical Council (ICC) on FOP, an autonomous group of FOP experts from around the world, recently issued a Statement Regarding Off-Label Medications for the Management of FOP.
At the 2023 FOP Family Gathering, during the session “Symptom Management Strategies for FOP,” Dr. Mona Al Mukaddam, University of Pennsylvania, shared about off-label use of medications in FOP. View her talk which starts at 31 minutes
The ICC statement notes:
“ICC also recommends review of active clinical trials before making decisions regarding off label use of these medications. Taking any of these off-label medications may disqualify you from participation in formal clinical trials. In addition, clinical trials are monitored closely for safety and efficacy, and information from those clinical trials can help the FOP community advance different therapeutic options and support future drug approvals. Information from off label use of a medication outside of a clinical study is not sufficient for drug approval.”
