FDA proposed aspirin labeling information; reinforces benefits of Halfprin brand

Business Wire, June 18, 1996

MIAMI--(HealthWire)--June 18, 1996--The Food and Drug Administration has announced a proposed change in the professional labeling for aspirin to reflect the cardiological benefits discovered in the ISIS-2 Trials.

The following excerpt from the Federal Register Proposed Rules was released Thursday June 13, 1996. -0- III. Summary of Agency Changes

In summary, the agency is proposing to add the following to the professional labeling in sec. 343.80(C): An indication for aspirin to reduce risk of vascular mortality in patients with a suspected acute MI; the findings of ISIS-2 study under "Clinical Trials;" a dosage of 160 to 162.5 mg for a suspected acute MI taken as soon as the infarct is suspected and then daily for at least 30 days; and a statement that this use of aspirin applies to both solid, oral dosage forms and buffered aspirin in solution.

To Add the findings of ISIS-2 study and improve readability is also proposing the following. Change the heading from "Indication" to "Indications;" add the subheadings, "Recurrent MI (Reinfarction) or Unstable Angina Pectoris" and Suspected Acute MI," Under headings "Indications;" "Clinical Trial," and "Dosage and Administration;" revise the text under "Gastrointestinal Reactionsi" and change from 300 mg aspirin to 160 mg aspirin daily the dosage level at which subjects should have biochemical measurements assessed; add subheading, "Bleeding," under the heading "Adverse Reactions" after ("Gastrointestinal Reactions") renumber existing reference (8) as reference (9); and assign a new reference (8).

Kramer Laboratories has been a leading proponent of aspirin therapy since its introduction of Halfprin(r) more than 3 years ago. It is now quite clear that as many as 10,000 lives could be saved each year through the use of low strength aspirin such as Halfprin(r). (Patients with acute MI or suspected acute MI and those at risk of additional cardiovascular occlusive event such as heart attack or stroke.) Halfprin is the only product currently available in both 162.5 mg and 81 mg strength.

For more information, a copy of the latest federal register and product samples call the Halfprin(r) hotline at 800/824-4894.

CONTACT: Halfprin Hotline

800/824-4894