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Adoair Diskusfulticasone propionate/salmeterol xinafoate dry-powder inhaler

Adoair Diskus (a combination of fulticasone propionate and salmeterol xinafoate taken by inhalation) was used by GlaxoSmithKline K.K. in April 2004 for the long-term maintenance treatment of asthma in adults and children. We opposed its approval and issued a letter of request to the Ministry of Health, Labor and Welfare (MHLW) and GSK in May 2005.

Our reasons were as follows:

1) One component, Fulticasone propionate, is reported to be linked to the risk of acute adrenal failure because it easily accumulates in organs.

2) Salmeterol xinafoate, another component, is a long-acting -stimulant (not2-selective). It should not be used regularly, because it may increase the risk of sudden death, which has already been proved in RCT and several large epidemiological investigations.

3) A combination of the above components for long-term treatment may increase the risk of harm. It is difficult to determine the best dose and judge when the right time to change the treatment process is. It is recommended that Adoair Discus combined with 50g of salmeterol xinafoate and 500g of fulticasone be inhaled twice a day.
This means that the total daily dose of fulticsone is 1000ug, which is more than the highest dose of 800g/day of Fultide (single component of fulticsone), and the risk of adrenal suppression increases.

Adoair was approved two years after our proposition in April 2007. The pediatric indication was withdrawn by GSK, and the Pharmaceutical Affairs and Food Sanitation Council concluded that Adoair should be used carefully on adult patients in a more serious condition.

The MHLW also ordered a post- approval study on the safety and effectiveness of long-term use as a condition for approval.

However, in January 2009, Adoair 100 Diskus(fulticasone100g /salmeterol25g) and 50Air(fulticasone50g /salmeterol25g) were approved for use in the treatment of childhood asthma without substantial evidence of safety and efficacy when used in mild cases and children under 4 years old.

We should disseminate this fact and act accordingly in order to prevent serious and fatal harm.

Topics

  • YAKUGAI Ombudsperson
  • Tie-up Group

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