E-DRUG: Labeling changes for diabetes drug troglitazone
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June 16, 1999 U.S. FDA Talk Paper
NEW LABELING AND USE CHANGES FOR REZULIN
Significant new changes are being made to the labeling and recommended
uses for Rezulin (troglitazone) - a drug used to treat type 2 diabetes
mellitus (non-insulin dependent diabetes mellitus, or adult onset
diabetes). These changes are being made because new safety information
(i.e., further evidence of serious and sometimes fatal liver injury in
patients treated with Rezulin) indicates that the use of Rezulin should
be limited to patients not adequately controlled by other therapy and
should not be used as initial single agent therapy in the treatment of
type 2 diabetes. The labeling changes also include recommendations for
more extensive monitoring of liver function in patients using Rezulin. A
patient information sheet has been added to the labeling and will be
available for distribution to patients by pharmacists with each Rezulin
prescription.
FDA and Parke-Davis agreed to these changes after careful analyses of
the drug's safety profile, drawing upon clinical trials data,
post-marketing surveillance data and the recommendations made by FDA's
Endocrinologic and Metabolic Drugs Advisory Committee during a March 26,
1999 meeting. The new labeling and other measures being taken regarding
Rezulin are in keeping with the recommendations made by that panel of
outside experts.
Parke-Davis is issuing a nationwide letter to healthcare professionals
notifying them of these modifications. The letter specifically notes
that:
�Rezulin is no longer indicated to be used as initial single agent
therapy.
�Prospective Rezulin patients need to have liver chemistries tested
before starting therapy, then monthly during the first year of therapy
(rather than just 10 times previously recommended). After the first year
of therapy patients should be tested quarterly (rather than
"periodically" as previously recommended).
�Within the next few weeks, the company will prepare a patient
information sheet with FDA-approved information about the safe and
effective use of Rezulin. This patient information sheet will be
available for distribution to patients by pharmacists with each Rezulin
prescription.
In addition to changes in labeling noted above, a new indication will be
added to Rezulin's labeling for its use in combination with sulfonyureas
and metformin in patients whose diabetes is not adequately controlled by
the combined use of just these other diabetes drugs. This indication is
based on new clinical data evaluated by the agency.
FDA urges patients to consult with their physicians before making any
changes in their use of Rezulin. Any adverse reactions associated with
the drug should be reported to the agency through MedWatch, FDA's
adverse reaction reporting system. Reports may be submitted to FDA by
telephone (800-332-1088), by fax (800-332-0178) or by mail to MedWatch,
HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20857. Reports can also be
filed via the internet at www.fda.gov/medwatch. Reports may also be
filed directly to the manufacturer.
[Editorial note: The use of troglitazone has been associated with over
40 cases of liver failure leading to deaths in nearly 30 of the cases.
The drug regulatory agency in the U.K. banned troglitazone over a year
ago. The company's letter to healthcare professionals in the U.S. can be
obtained by visiting FDA's website: www.fda.gov. Click on Medwatch and
then on What's New.... Syed Rizwanuddin Ahmad]
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