Claim: Over 25% of the children taking dinutuximab experienced negative side effects including pain, hypotension, and fever; the drug carries black box warnings for neurotoxicity and infusion reactions.
Evidence: More than 25% of children taking these drugs experienced pain, fever, hives, vomiting, diarrhea, bone marrow suppression causing loss of platelets, red blood cells, white blood cells, and albumin, hypotension, electrolyte imbalance including low sodium, potassium, and calcium, elevated transaminases, infusion reactions, and capillary leak syndrome. The US label for dinutuximab carries black box warnings for life-threatening infusion reactions and neurotoxicity, as it causes severe neuropathic pain, and can cause severe sensory neuropathy and severe peripheral motor neuropathy.