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Submission of requests to MHLW (Ministry of Health, Labour and Welfare) on amendments to the °»Precautions for Use°… column on the package inserts of benzodiazepine type drugs


On November 1, 2017, Medwatcher Japan submitted a letter of opinion to the Ministry of Health, Labour and Welfare requesting amendments to the °»Precautions for Use°… column on the package inserts of benzodiazepine type drugs.

Benzodiazepine type drugs exert the following actions: anxiolytic, hypnotic, myorelaxant, and anticonvulsant. Most anxiolytics and hypnotics sold in Japan are in fact benzodiazepine type drugs. It is generally believed that they have few side-effects, and they are not only used in psychiatry and psychosomatic medicine, but also readily prescribed in general internal medicine, orthopaedic surgery and others. Subsequently, it is estimated that Japan has the highest prescription number per capita in the world.

However, benzodiazepine type drugs can cause both physical and psychological dependency in just a few weeks, when taken not only on high doses, but also on conventional (approved) prescription doses. This can result in confusion, hallucinations and other severe withdrawal symptoms. Due to this risk, in the United States and European countries, there are guidelines in place recommending that benzodiazepine type drugs should not be prescribed for any more than 2-4 weeks.

In October 2015, our organization submitted a written request (°»Written Request Regarding Benzodiazepine Type Drugs°…) to the Ministry of Health Labour and Welfare, asking them to clearly state the risk of dependency on conventional (approved) prescription doses in the warning column of the drug package inserts, and to place a limitation on the period of repeat prescriptions.

Then on 21 March 2017, one and a half years later, the ministry acknowledged that approved prescription dosing can cause dependency, and ordered each of the drug manufacturers to amend the °»Precautions for Use°… column to state that dependency can form on repeated dosing.

However, in actual fact, the only amendment made was the dropping of the word °»large°… from °»repeated large doses°… in the original entry, and subsequently, this cannot be deemed as providing a sufficient cautionary warning to prescribers about the risk of dependency forming on conventional (approved) prescription doses.

In addition, despite the ministry having ordered the inclusion of the entry, °»prolonged continued use should be avoided,°… this wording has the potential to result in individual prescribing doctors deciding for themselves what °»prolonged°… actually means, leaving it wide open to interpretation. Subsequently, the ministry°«s response is clearly inadequate.

Therefore, on 1 November 2017, our organization submitted a report to the ministry asking them to:

(1) Clearly state dependency on conventional (approved) prescription doses, and shift this entry from the °»Precautions for Use°… column to the °»Warning°… column.

(2) Limit prescriptions of repeat doses to 4 weeks bringing Japan in line with other countries.

These requests were made among others in the report.

NB: To patients currently on benzodiazepine type drugs and families:

Regarding reduction and withdrawal, you will need to work closely with your physician, as caution must be exercised when making decisions. For this purpose, it is advisable to use The Ashton Manual referred to in the written request, dated 28 October 2015, as a point of reference.

You should never reduce, or withdrawal, using your own judgement without consulting your physician, as it can be very dangerous to do so.

Please be advised that our organization is unable to accommodate individual enquiries or assist with the introduction of treatment facilities.