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Risperdal-Causing Deaths in Elderly
April
25, 2003 – MedWatch
Janssen Pharmaceutica and FDA revised the WARNINGS section of
the prescribing information for Risperdal (risperidone), indicated
for the treatment of schizophrenia. Cerebrovascular adverse events
(e.g., stroke, transient ischemic attack), including fatalities,
were reported in patients in trials of risperidone in elderly
patients with dementia-related psychosis. In placebo-controlled
trials, there was a significantly higher incidence of cerebrovascular
adverse events in patients treated with risperidone compared
to patients treated with placebo. RISPERDAL has not been shown
to be safe or effective in the treatment of patients with dementia-related
psychosis.
Dr. Hansen’s
Notes:
Although you may think that this information is not relevant
for you, I report it to you because once a drug is approved
for sale, it can be prescribed for other diagnoses than the
one for which it was originally intended.. Last month’s
Drug Alert was about just such a drug: Lamictal, which is an
anti-epileptic drug that is now being prescribed for bi-polar
depression.
Some doctors
may be prescribing Risperdal for patients with dementia or
Alzheimer’s disease, or just because they are
irritable and old and unwilling to cooperate with nursing home
staff. You should check your parents’ meds if they are
in a nursing home.
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