Call to switch anti-epileptic tablet to powder amid global recall
The TGA has urged doctors prescribing the anti-epileptic vigabatrin to switch patients to oral powder sachets when issuing new scripts amid a national shortage of the drug’s tablet form.
Affected patients should also be advised they may be dispensed less than a month’s supply at a time and that each sachet contains the same dose as one vigabatrin (Sabril) 500mg tablet, the regulator said.
The medication is indicated for adults and children living with serious epileptic conditions that cannot be controlled satisfactorily with other anti-epileptics.
The shortage of the tablets began in mid-July and is expected to last until early October, while the sachets were briefly unavailable in July.
It was triggered when the drug’s sponsor, Sanofi-Aventis Australia, issued a global recall after detecting a contaminating ingredient in both products that could pose a serious risk to life or health.
While unaffected stock of the sachets has since become available, the TGA said just two batches of the tablets were subject to recall because of the “critical” nature of the medication and “the impact a widespread shortage created by a full recall might have”.
“If possible, [doctors] should prescribe one box of 60 sachets for each box of 100 tablets you would normally prescribe to help all patients have access to the sachets,” it advised.
“When filling a script, in certain circumstances and if practical for the patient, the pharmacist may give less than the full supply at once and ask the patient to come back later to collect the balance of that month’s supply to make sure there is enough for all patients.”
But the TGA stressed that patients would not have to return any tablets they currently had at home and could continue to use the medicine as prescribed.
Melbourne neurologist Professor Mark Cook told AusDoc he did not anticipate that the shortage would have a large impact since vigabatrin had fallen out of use owing to ocular and neurological side effects.
“But there are still some patients who continue to take it, … and it has been the preferred treatment for paediatric patients with infantile spasms for some time,” he said.
“For my patients, I have been using the sachet form as an alternative.”
Australian guidelines currently recommend vigabatrin as a first-line treatment for infantile spasms associated with tuberous sclerosis complex.
Professor Cook, who is director of neurology at St Vincent’s Hospital in Melbourne, added that the shortage was unexpected and had taken clinicians “by surprise”.
“It seems pharmaceutical companies are reporting to the TGA, but we find out through patients and asking colleagues.”
According to the Australian Institute of Health and Welfare, some 8800 (0.3%) of all scripts dispensed in 2019/20 were for vigabatrin.
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