- A major US drug maker that produces a popular medicine
for schizophrenia is acknowledging that it minimized the risks and made
misleading claims in promotional materials for the drug.
-
- Janssen Pharmaceutica Products LP, the maker of Risperdal,
has sent a letter to health care providers to clarify the risks involved
with the use of Risperdal.
-
- The move comes after the US Federal Drug Administration
issued a warning letter to Janssen Pharmaceutica to update their product
information. The FDA said Janssen Pharmaceutica made misleading claims
and omitted information regarding hypoglycemia and diabetes.
-
- The warning letter also stated Janssen Pharmaceutica
had made misleading claims that 'Risperdal is safer than other atypical
antipsychotics'.
-
- "Risperdal is indicated for the treatment of schizophrenia
and for the short-term treatment of acute manic or mixed episodes associated
with Bipolar I Disorder. Risperdal is also indicated in combination with
lithium or valproate for the short-term treatment of acute manic or mixed
episodes associated with Bipolar I Disorder," according to background
information on the drug Risperdal, issued by the FDA in its warning letter.
-
- Worldwide, Risperdal is prescribed to more than 10 million
people and accounts for about $2 billion in annual sales.
-
- Copyright © Health Talk http://www.healthtalk.ca/misleading_claims_07252004_8290.php
- \
|
