..• and US FDA rules on drug labelling changes

VIEWS & REVIEWS

The US FDA has published its final rule regarding changes to drug labelling that will lead to the inclusion of information specifically relating to elderly patients (Le. patients aged ~ 65 years), reports lAMA.

The rule was published in the August 27 1997 Federal Register and, although it becomes effective 1 year after the publication date, will be implemented gradually over a 5-year period.

The rule means that drug manufacturers will have to include additional information in the product labelling (some of which will be included in a 'Geriatric Use' subsection), including information regarding specific indications for use in the elderly, dosing information for the elderly, any known adverse effects associated with use of the drug in the elderly, and any known hazard or monitoring requirements associated with use of the drug in the elderly.

Priority drug categories The FDA has designated 6 priority drug categories

that must include information concerning the elderly in their product labelling by Aug 27 1998. These drug categories are: psychotropic agents; NSAIDs; digoxin, antiarrhythmic agents and calcium antagonists; oral hypoglycaemics; anticoagulants; and quinolones.

The deadline for inclusion of such information for all other drugs will vary according to the year that the agent's active moiety or biological product license was first approved, notes lAMA. Skolnick AA. FDA sets geriaIric drug usc labeling deadlines. Journal of the American Medical Association 278: 1302.22-29 Oct 1997 80062237>

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Inphanna- 1 Nov 1997 No. 1111