FDA proposed aspirin labeling information; reinforces benefits of Halfprin brand.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 infarct /in·farct/ (in´fahrkt) a localized area of ischemic necrosis produced by occlusion of the arterial supply or the venous drainage of the part. 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 Noun 1. buffered aspirin - aspirin coated with a substance capable of neutralizing acid (trade name Bufferin) Bufferin acetylsalicylic acid, aspirin, Bayer, Empirin, St. 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 un·sta·ble angina n. Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain. 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 sub·head·ing n. See subhead. subheading Noun the heading of a subdivision of a piece of writing Noun 1. , "Bleeding," under the heading "Adverse Reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. " after ("Gastrointestinal Reactions") renumber re·num·ber tr.v. re·num·bered, re·num·ber·ing, re·num·bers To number again or in a different order. 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 occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. 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 |
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