Oral ketoconazole use restricted over liver concerns
Latest advice from the MHRA |
Oral ketoconazole (Nizoral) should no longer be used as first-line antifungal treatment or to treat superficial infections, the Medicines and Healthcare products Regulatory Agency has decided following a review of evidence.
The agency has announced in its March 2008 Drug Safety Update the removal
of several therapeutic indications for oral ketoconazole because of serious
hepatotoxicity risks.
The risk of serious hepatotoxicity with oral ketoconazole increases with
duration of treatment, the MHRA says, adding that courses of longer than
10 days should be given only after full consideration of the extent of
treatment response and of the balance of risks and benefits of continuing
treatment.
“Liver function must be monitored in all patients who are receiving
ketoconazole tablets. Tests should be done before starting treatment,
at week 2 and
week 4 of treatment, and then continued monthly. Treatment should be
stopped if any liver parameters are elevated above three times the normal
limit,” the Drug Safety Update states.
The summary
of product characteristics for Nizoral has been updated accordingly
(PJ, 23 February 2008, p211).
The MHRA has also warned about the potential for serious skin reactions
and psychiatric symptoms for patients taking modafinil (Provigil) for
excessive sleepiness. The agency says that modafinil should be discontinued
at the first sign of rash or if any psychiatric symptoms are experienced,
and not restarted.
Boots Medisure Concerns
about the potential for serious dosing errors with Boots Medisure
domiciliary dosing system have been
flagged up by
the MHRA in this month’s
Drug Safety Update.
The agency has received one report of a patient
receiving an incorrect dose of medicine because individual compartments
of the Medisure
system had not sealed fully, allowing pills to migrate between different compartments.
Boots
has issued a bulletin informing staff about the problem and is
revising its procedures to prevent future occurrences, the MHRA
says. |
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