Botulinum Black Box: How Much to Disclose?

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG