GMP, Life Sciences, Regulatory Focus News Letter

New Zealand’s Medsafe to Ban Sale of Migraine Drug Next Year

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is set to ban the sale of the Cafergot migraine drug. Medsafe decided to stop the distribution of the AFT Pharmaceuticals’ product after concluding the benefits no longer outweigh the risks.

Cafergot, which contains ergotamine tartrate and caffeine, is used in the treatment of acute attacks of migraine with or without aura in adults. The drug was approved in New Zealand in the late 1960s. Other countries also used ergots such as ergotamine tartrate in the past but authorities including the United Kingdom’s National Institute for Health and Care Excellence and the German Society of Neurology now recommend against their use.

The recommendations against the use of ergots are underpinned by the lack of well-documented efficacy evidence from prospective studies and concerns that they have worse safety and tolerability profiles than other migraine drugs, such as triptans.

Adverse events linked to Cafergot in migraine are relatively rare, with the Centre for Adverse Reactions Monitoring (CARM) identifying five reports as of the end of June. One of the reports covered a case of potential pancreatitis that led the Medicines Adverse Reactions Committee (MARC) to look into the drug.

A report presented to MARC said there were “fewer reports than predicted,” although the authors think that may be because use is relatively low and, as an old drug, people may have stopped reporting side effects. The report identified close to 1,800 patients who used Cafergot in New Zealand last year.

Healthcare professionals who provided feedback for the report said Cafergot is rarely prescribed today, although one person noted they know of a “small handful” of patients who use it safely. Knowledge of those people led that healthcare professional to say, “It would be a shame to lose [Cafergot] altogether.” Some of the other healthcare professionals expressed similar sentiments.

Despite that, MARC recommended the withdrawal of Cafergot at a meeting earlier this year. That led to a Medsafe notice last week that set 1 May as the date of the withdrawal of Cafergot from the New Zealand market. The timeline reflects MARC’s recommendation of a six-month transition to enable patients to safely move to new medicines.

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