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FDA REQUESTING CORTICOSTEROID "WARNING" SECTION

Executive Summary

FDA REQUESTING CORTICOSTEROID "WARNING" SECTION to caution doctors that long-term or high-dose treatment with oral, injected or inhaled corticosteroids, such as for asthma, allergies or juvenile arthritis, may cause severe infections or death in patients exposed to chicken pox or measles. In a Dec. 1 letter, FDA requested corticosteroid manufacturers to make changes in the "warnings" and "precautions" sections of physician labeling and asked that the new information be incorporated into labeling "at the next printing, or within 90 days of this letter." FDA requested the labeling changes after reports of severe illnesses and death from chicken pox infections in people whose immune systems were suppressed from taking long-term or high doses of corticosteroids. FDA said the labeling change request letters have been sent to approximately 15 brandname pharmaceutical companies and an unspecified number of generic firms. The letter says that "a supplemental application should be submitted which provides for the change; however, the change may be put into effect in advance of approval." The revised "warnings" section states: "Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chicken pox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure." The revised "precautions" statement requested by FDA reads: "Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox, measles and, if exposed, to obtain medical advice." The proposed label change advises that for patients exposed to either chicken pox or measles, "therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered." Burroughs Wellcome's antiviral Zovirax (acyclovir) was recommended for approval for chicken pox in children by FDA's Antiviral Drugs Advisory Committee on Nov. 12 ("The Pink Sheet" Nov. 18, p. 15). In a Dec. 1 announcement of the proposed label change, HHS Assistant Secretary for Health James Mason, MD, said it is "imperative" that children and patients at risk "be immunized at an early age." However, Mason noted that there is no approved vaccine for chicken pox. The product license application for Merck's Varivax vaccine has "at least a year to go," Merck recently commented to analysts ("The Pink Sheet" Nov. 18, p. 13).

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