Allergans nyeste indlægsseddel: botox kan give botulisme

På Allergans nyeste indlægsseddel fra 2017 er der nederst på side 19 en advarsel indrammet, hvor der står, at botox kan give botulisme. Teksten er:

“• Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism.
The symptoms of BOTULISM include:
o loss of strength and muscle weakness all over the body
o double vision, blurred vision and drooping eyelids
o hoarseness or change or loss of voice (dysphonia)
o trouble saying words clearly (dysarthria)
o loss of bladder control
o trouble breathing
o trouble swallowing

These symptoms can happen hours, days, to weeks after you receive an injection of BOTOX or BOTOXCosmetic.”

Allergan skriver et par linjer længere nede, at man ikke har bekræftede tilfælde af botulisme efter injektioner mod migræne, rynker, armsved eller nervøs blære, når der er brugt doser i de anbefalede mængder:

“There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.”

Allergans indlægsseddel kan læses her: