KRAMER LABS' OTC 1/2HALFPRIN CITED BY FDA FOR UNAPPROVED CARDIAC CLAIMS

KRAMER LABS' OTC 1/2HALFPRIN CITED BY FDA FOR UNAPPROVED CARDIAC CLAIMS, including prevention of heart attack, in a July 16 warning letter. FDA advised Miami-based Kramer that marketing 1/2Halfprin enteric coated aspirin tablets (81 mg and 165 mg) for the prevention or treatment of myocardial infarction, unstable angina or other cardiovascular-related indications "represents an unapproved new use." The FDA warning letter refers to consumer-directed advertising for 1/2Halfprin that includes statements such as "Low strength aspirin best to prevent heart attacks....Full strength aspirin doesn't do the job well because it slows the body's anti-clotting action....You don't have to break tablets to get the exact amount of aspirin you doctor wants for you..." While prevention or treatment of MI and unstable angina have been approved for physician labeling of aspirin products, FDA said it "does not regard the above named FDA-sanctioned cardiovascular- related indications for use to be amenable to self-diagnosis and treatment by the lay public without the supervision of a physician." Therefore, information directed at parties other than physicians is a violation of the regulations, the agency maintained. The agency also cites Kramer for placing similar claims in trade promotional materials and medical and professional journals, including the Journal of the American Medical Association, the Journal of the American College of Cardiology, U.S. Pharmacist and Medical Economics. For example, an ad directed at pharmacists states that "most recommendations for heart attack prevention require doses that differ from the standards 325 mg strength of conventional aspirin tablets....Halfprin...a new option pharmacists can suggest to customers who take aspirin for heart attack prevention." The name 1/2Halfprin also is misleading, the agency says, because it suggests that one 1/2Halfprin tablet is one-half the regular aspirin tablet strength. While it is true for the 165 mg 1/2Halfprin dosage strength, FDA notes that the 81 mg tablet is not one-half but one-fourth the standard dosage strength. "In this regard the 81 mg version is misbranded," FDA said. FDA added that it considers the name 1/2Halfprin to be misleading "within the context of the labeled dosage directions for use as an analgesic/antipyretic." Noting that 1/2Halfprin's labeled dosage directions for 165 mg tablets specify dosages from 330 mg to 660 mg every four hours, FDA stated; "This dosage range does not represent one-half of the regular adult aspirin dosage range of 325 mg to 650 mg for these indications."