News: A Healthy Dose for Inhalers
|FDA's draft guidance for metered dose inhalers will help patients keep track of their dosages.|
FDA is recommending that metered-dose inhalers (MDIs) for oral use come with a dose-counting device to enable patients to track how many doses of medication are left.
In a draft guidance published December 10, which can be viewed at http://www.fda.gov/cder/guidance/4806dft.pdf, the agency noted that currently marketed oral MDIs have no practical way to track the number of doses left. This, it stated, can cause patients to throw away MDIs with doses left, which is wasteful, or to use the product beyond the recommended number of doses, which can be dangerous.
MDIs usually contain more formulation than required to expel the labeled number of doses. The excess is there to ensure the dosing consistency of each spray up to the labeled number. Doses after the labeled number usually are inconsistent and eventually contain negligible amounts of drug substance, so it is important that the patient does not assume that these are proper doses.
Today, however, the agency states, "technological advances have made it possible for manufacturers to incorporate into their devices economical, reliable, integrated dose counters to reflect how many actuations remain in a canister." Therefore, the agency wants new oral MDIs to adopt dose counters. Oral MDIs currently marketed in the United States do not have dose counters, though some multidose dry-powder inhalers do.
The guidance would not apply to currently marketed MDIs, or nonoral MDIs. Written comments were due by February 11. For further information, contact Sandra L. Barnes at 301/827-1050.