Aspirin warning label

Selectivity for COX-1 versus COX-2 is variable and incomplete for the older NSAIDs, but many selective COX-2 inhibitors have been synthesized. The selective COX-2 inhibitors do not affect platelet function at their usual doses. In testing using human whole blood, aspirin, ibuprofen, indomethacin, piroxicam, and sulindac are somewhat more effective in inhibiting COX-1. The efficacy of -2-selective drugs equals that of the older NSAIDs, while gastrointestinal safety may be improved. On the other hand, selective COX-2 inhibitors may increase the incidence of edema and hypertension. As of December 2008, celecoxib and the less selective meloxicam are the only COX-2 inhibitors marketed in the USA. Rofecoxib and valdecoxib, two previously marketed, selective COX-2 inhibitors, have been withdrawn from the market due to their association with increased cardiovascular thrombotic events. Celecoxib has an FDA-initiated "black box" warning concerning cardiovascular risks. It has been recommended that all NSAID product labels be revised to include cardiovascular risks. 

Though side effects and allergic responses are rare, the label warns that aspirin may cause nausea and vomiting and should be avoided late in pregnancy. Because aspirin can interfere with blood clotting, it should not be used by hemophiliacs or following surgery of the mouth. 

PDA. 2003. U.S. Pood and t>rug Aciiiiinistration. Labeling for oral and rectal over the counter drug products containing aspirin and nonaspirin salicylates Reye s syndrome warning. Final rule. Fed. Regist. 68 18861-18869. 

---