Kye’s discussion with the FDA I think is a warning for everyone – we ALL need to be better consumers – the operator kept telling him that due to it being an ‘off label’ use of Botox that they were unable to help……..she said there have been no studies for these ‘off label’ uses………so we can’t give you any advice/help.
The problem is that injectors are not providing us with this specific information……Why can’t they inform us that ‘What you are about to do has not had research studies completed THEREFORE if something does go wrong we don’t know what the consequences will be and how to rectify these………’
If you read the Allergan prescribing information in detail it does list what Botox is specifically approved for…….if you use Botox outside of these recommendations then you are not covered safety wise.
Why are injectors legally allowed to use Botox for ‘off label’ uses…………not only are they using it for off label use they are also not providing the appropriate safety warnings – WHY is this allowed to happen?
I was injected into a vulnerable area and the warnings were not discussed with me……….I really wish that there had been warnings as I would definitely NOT have had these injections………..
Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events includingfatal outcomes have been reported in patients who had received BOTOX injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Some patients had pre-existing dysphagia or significant debility. (Safety and effectiveness have not been established for indications pertaining to these injection sites.) Pneumothorax associated with injection procedure has been reported following the administration of BOTOX near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.