Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Manufacturers of licensed botulinum toxin (Botox) are now required by the Food and Drug Administration (FDA) to strengthen warnings on its product labeling and add a black box warning – the strongest warning the agency can require – of risk of adverse events when the effects of the toxin spread beyond the site where it was injected. Notice of the safety label update was issued this week by the FDA to cosmetic surgeons, neurologists and consumers.

The black box warning will be placed on established drug names for Botox/Botox Cosmetic, Dysport and Myobloc to reinforce individual potencies and prevent mediation errors. It also provides recommendations for health care professionals, patients, family members and caregivers to consider.

The warning follows an ongoing safety review initiated in February 2008. The study’s postmarketing review indicated the greatest risk was when the product was used to treat muscle spasticity in both pediatric and adult patients (which is not an FDA-approved use) or cervical dystonia in adults. However, some reports of adverse events could be associated with use of Botox following dermatologic use.

Reported cases of spread of botulinum toxin effect beyond the site of injection were described as botulism or involved symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision or respiratory distress. Serious case reports described hospitalizations involving ventilatory support and/or placement of gastric tube, and reports of death.

Manufacturers of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) are also required by the FDA to develop and implement a Risk Evaluation and Mitigation Strategy (REMS), including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would include a Medication Guide that explains the risks to patients and their families and caregivers.

The FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specific number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

This entry was posted on Thursday, August 6th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.