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 WASHINGTON, Dec. 2 /PRNewswire/ -- The Food and Drug

Administration has asked the makers of corticosteroid drugs to warn doctors that long-term or high-dose treatment with these products may place patients exposed to chicken pox or measles at increased risk of unusually severe infections or even death.
 Corticosteroids are drugs commonly prescribed and used in children to treat a variety of chronic conditions such as asthma, allergies and juvenile arthritis. One corticosteroid side effect is a suppression of the human immune system. Immunosuppression has been reported with different doses and treatment lengths but, most often, problems occur with either low-dose prolonged treatment or with moderate- to high-dose treatments of varying durations.
 In part because of the efforts of one parent -- Rebecca Cole of Jacksonville, N.C. -- FDA became concerned that the medical community and many parents may fail to recognize the serious risk to people taking corticosteroids if they become infected with some common viruses. Cole's 12-year-old asthmatic son Christopher, while undergoing treatment for the first time with a commonly prescribed corticosteroid known as methylprednisolone, died of complications from chicken pox.
 This case, together with other reports of severe illnesses and deaths resulting from chicken pox infections, led the agency to call for a warning to doctors and patients about the potential seriousness of this kind of medical situation.
 FDA Commissioner David A. Kessler, M.D., said: "As a pediatrician, I am concerned that even though corticosteroids are essential in controlling very serious diseases, some parents may not be aware or their doctors may not have warned them that children undergoing treatment with these drugs may be vulnerable to serious complications. These complications can result from what we usually consider benign childhood virus diseases -- particularly chicken pox, for which there is no preventive vaccine yet available.
 "Many children need these drugs, and stopping them without medical supervision may be very dangerous. But it is also important that parents be alert to the risks if their children are exposed to or get chicken pox or measles while taking corticosteroids. This awareness will hopefully cause them to seek their doctor's advice and treatment," Kessler said.
 Because of these concerns, the FDA is requesting that all manufacturers of oral, injected and inhaled corticosteroids include in the "Warnings" section of the physician labeling the following statement:
 "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. If exposed, 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."
 FDA told manufacturers that the "Precautions" section of the physician labeling of corticosteroids should also include the following information for patients:
 "Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice."
 Manufacturers of corticosteroids have been requested to incorporate the "Warning" and "Precautions" information in their labeling within 90 days.
 James O. Mason, M.D., assistant secretary for health, said that despite the new labeling change for these drugs requested by FDA, it is important for patients and parents of children undergoing treatment with corticosteroids to be vigilant. "It is imperative that all children be immunized at an early age against infectious diseases for which we have effective vaccines, and that includes measles.
 "But in the case of chicken pox, no vaccine is yet available. Therefore, immunosuppressed children and their parents must become educated about their risks of contracting infections such as chicken pox or measles. Even though there are medications that may help infected high-risk patients, the best protection is avoiding exposure," he said.
 FDA is an agency within the Public Health Service.
 -0- 12/2/91
 /CONTACT: Faye Peterson of the Food and Drug Administration, 301-443-3285 or, after hours, 301-596-9639/ CO: Food and Drug Administration ST: District of Columbia SU: HEA MTC IN:

SB-DC -- DC029 -- 8503 12/02/91 16:47 EST
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Date:Dec 2, 1991

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