Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A prescription drug given to counter a side effect of radiation for head and neck cancer now carries a warning about possible serious adverse reactions to the medication known as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Ethyol (amifostine) was among 29 drugs listed in a Jan. 30th FDA MedWatch announcement of drug products with safety labeling changes to their boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package inserts and medication guides.

Ethyol is a prescription medication given by injection before postoperative radiation treatment sessions for head and neck cancer to lower the rate of moderate to severe dry mouth, also known as xerostomia. It is often prescribed when radiation includes the parotid glands, or the largest of the salivary glands.

The changes to contraindications and warnings for Ethyol include a warning of cutaneous reactions including erythema multiforme, SJS, TEN, toxoderma and exfoliative dermatitis. The reactions have been reported most frequently when Ethyol is used to protect against the effects of radiation. According to the new safety labeling information, some of the cutaneous reactions have been fatal or have required hospitalization and/or discontinuance of therapy.

Patients receiving injections of Ethyol should be carefully monitored as serious cutaneous reactions may develop weeks after initial use, according to the revised labeling.

The new labeling changes were approved by the FDA Center for Drug Evaluation and Research last November.

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