Executive SummaryAccording to a draft proposal, FDA plans to require that a warning statement be included in the labeling of all Rx drugs for human use which contain sulfites that states: "Contains (insert the name of the sulfite, e.g., sodium metabisulfite), a sulfite that may cause serious allergic-type reactions (e.g., hives, itching, wheezing, anaphylaxis) in certain susceptible persons. Although the overall incidence of sulfite sensitivity in the general population is probably low, it is seen more frequently in asthmatics or in atopic nonasthmatic persons." The proposal has been signed by HHS Secty. Heckler and sent to the Office of Management and Budget.
You may also be interested in...
Alnylam’s Givlaari for acute hepatic porphyria is also among the 14 new products that could get an EU approval recommendation this week.