NPA concerned about fluconazole P-to-GSL reclassification
The National Pharmacy Association has expressed concern about the Medicines and Healthcare products Regulatory Agency's proposal to reclassify
fluconazole 150mg capsules from a pharmacy-only to a general sale list medicine (PJ, 1 October, p398). And Bayer, manufacturer of Canesten Oral (fluconazole), has warned that the reclassification may pose a risk to pregnant women.
In its response to the MHRA consultation, the NPA says it is not convinced
that fluconazole can be used safely and effectively without the supervision
of a health care professional. “In our view vaginal candidiasis
is difficult to self-diagnose because the symptoms are similar to other
disorders such as bacterial vaginosis or genital herpes. In studies investigating
the cause of recurrent vaginitis, presumed to be candidal by patients,
candidal species were in fact isolated in only 16 per cent of cases.”
The NPA is also concerned that the proposed patient information leaflet
does not restrict the product to women previously diagnosed with thrush
by a doctor and that, without advice from a pharmacist, patients with
heart conditions may risk serious adverse effects.
Bayer points out that fluconazole 150mg is contraindicated in pregnancy
and believes that reclassification may risk exposing pregnant women to
the drug.
The company also argues that the use of fluconazole “on the go” significantly
reduces the chance of women reading the whole of the patient information
leaflet before treatment. “In this regard, the pharmacist plays
a critical safety role when questioning at point of purchase,” Bayer
says.
The application to reclassify fluconazole was made by Relonchem, which
manufactures pharmacy-only fluconazole 150mg capsules. The consultation closes
on 1 November. |
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