FDA Update on Botox Safety

Last month I posted a blog entry about the recent media reports of death from Botox. Just today, the Food and Drug Administration (the FDA) released a report in response to these claims. Fortunately, but not surprisingly, my suspicions about what had occurred in these Botox cases were confirmed. Here are the highlights of their conclusions about the Botox deaths:

•None of the cases involved adults. •None of the cases involved injections in the face. •None of the cases involved the cosmetic use of Botox.

According to the FDA investigation, the most serious cases—those that included hospitalization or death—occurred mostly in children treated for cerebral palsy-associated limb spasticity, which is not an FDA-approved use of Botox.

Below is a highlight of the FDA's conclusions today from their "Early Communication about an Ongoing Safety Review":

"What does FDA know now about these data?

The FDA has reviewed post-marketing cases from its Adverse Event Reporting System (AERS) database and from the medical literature of pediatric and adult patients diagnosed with botulism following a local injection with a marketed botulinum toxin product.

The pediatric botulism cases occurred in patients less than 16 years old, with reported symptoms ranging from dysphagia to respiratory insufficiency requiring gastric feeding tubes and ventilatory support. Serious outcomes included hospitalization and death. The most commonly reported use of botulinum toxin among these cases was treatment of limb muscle spasticity associated with cerebral palsy. For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in these cases. For Myobloc, reported doses were from 388 to 625 U/kg.

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities. Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported. The doses for Botox ranged from 100 to 700 Units and for Myobloc from 10,000 to 20,000 U.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions after the review of the data are completed. "

Needless to say, Botox is a powerful drug that should only be administered by doctors properly trained in the use of these medications. In my office, we take Botox seriously. For example, the injections are personally prepared by me so that I can be assured of the exact concentration. I personally inject the patients. And all of our patients are evaluated for neuromuscular and other conditions that may be risk factors for adverse outcomes. Patient safety is paramount. Fortunately, Botox's safety in terms of its cosmetic use in the face remains well-established.

For more information, you can read the full FDA report here and review my original blog entry on this subject here.