Letter to Doctors on
Liver Toxicity Associated with Trovan
14 June 1999 |
Dear Doctor,
I wish to draw your attention to the recent Food and Drug Administration (FDA) report of liver toxicity among patients who have been put on the new drug Trovan (Trovafloxacin/ Alatrofloxacin).
The drug was registered in Hong Kong in October 1998. According to the importer Pfizer Corporation, the drug has been supplied to about 100 private doctors and all private hospitals. Pfizer has also confirmed that these doctors and hospitals have been separately informed.
Based on 14 reported cases (six fatal) of acute liver failure associated with Trovan use, the FDA has advised that the indications for Trovan use should be restricted and that therapy should only be initiated in an in-patient setting . Only serious and life- or limb-threatening conditions may warrant the use of Trovan. These include :
You are advised to take note of these developments and exercise caution when considering initiation of Trovan use on your patients. Please bring this to the attention of medical colleagues and report to us as matters of urgency if you should encounter situations suggestive of Trovan-induced toxicity.
Thank you.
Yours sincerely,
(Dr Regina Ching)
for Director of Health