| "HHS News, P91-31,
December 2, 1991. The Food and Drug Administration has asked the makers of
corticosteroid drugs to warn doctors that the 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 --
Mrs. Rebecca Cole of Jacksonville, NC. -- 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
virus. Mrs. 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, MD, 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."
(Now we do have a vaccine, Varivax, but not all children are being
immunized.) |
