FDA to strengthen warnings on Botox type drugs

William Atkins
Friday, 01 May 2009 02:05

Science - Health

As mentioned earlier, the only reported death and hospitalization have been reported after the medical use of the drug, not for its cosmetic usage.

When used for medical purposes, its brand names include Botox, Dysport, Myobloc, Neurobloc and Xeomin.

The WSJ article states, “Specifically, the FDA said it would require the agency's toughest boxed warning regarding the risk of adverse events when the effects of the toxin - or the active ingredient used in the products - spread beyond the site where it was injected.”

It added, “The FDA also said it would require manufacturers to develop a so-called risk evaluation and mitigation strategy or REMS that would provide more information to doctors and patients about risk of botulinum toxin effects and to explain that individual products cannot be interchanged.”

Dr. Ellis Unger, the FDA’s acting deputy director, stated, “Botulinum products have benefits but also can cause serious problems so it's important that anyone who administers or receives these products understand the risks involved.” [Reuters: “Botox must carry strong warning on risks: FDA”]

Dr. Unger stated, "The hospitalizations are very few. Deaths are very rare, but they have been reported.” [Reuters]

The warnings include a easy-to-read patient guide that explains the risks of using the drug. The warning also applies to the physicians administering the drug to their patients. They will be warned to not use different botulinum toxin products on the same patient.

The Medical Officer's Review of Botulinum Toxin Type A (review completed November 2001 and review amended March 2002) is found at the FDA website (pdf file).