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BOTOX/blepharospasm alert
As some of you know, BOTOX injections can be used to treat blepharospasm. Typically patients get injections every 3 months.
I have heard from two different patients quite recently who experienced sudden complications from an injection - in one case, the lid froze open, causing severe pain and great risk to the cornea, and in another, there are less severe but still serious problems with lid closure. I am deeply concerned about this because it's a serious thing to have happen and if I've personally heard of two in a row, there's definitely more of it happening out there. LID PARALYSIS AND INCOMPLETE LID CLOSURE ARE NOT LISTED AS RISKS on the FDA's page on Botox nor are they listed in the Botox consent forms that I have reviewed! The closest I've seen is "droopy eyelid which may continue for a few weeks".
If there are any more of you out there, I want to urge you to tell your doctor to report this complication to the FDA - and, in any case, please file a Medwatch report on your own just in case your doctor doesn't.
Here is the link to the FDA site for adverse event reporting.
As we witnessed so recently with LASIK, failure by doctors and manufacturers to report adverse events associated with drugs and medical devices has serious repercussions: (1) it cripples the FDA's ability to pursue post-market safety issues, and (2) it prevents future patients from receiving accurate information about the risks they may be undertaking.
As conscientious consumers we need to do our part to fill the gap and to educate our doctors when necessary.
Thanks everybody.
I have heard from two different patients quite recently who experienced sudden complications from an injection - in one case, the lid froze open, causing severe pain and great risk to the cornea, and in another, there are less severe but still serious problems with lid closure. I am deeply concerned about this because it's a serious thing to have happen and if I've personally heard of two in a row, there's definitely more of it happening out there. LID PARALYSIS AND INCOMPLETE LID CLOSURE ARE NOT LISTED AS RISKS on the FDA's page on Botox nor are they listed in the Botox consent forms that I have reviewed! The closest I've seen is "droopy eyelid which may continue for a few weeks".
If there are any more of you out there, I want to urge you to tell your doctor to report this complication to the FDA - and, in any case, please file a Medwatch report on your own just in case your doctor doesn't.
Here is the link to the FDA site for adverse event reporting.
As we witnessed so recently with LASIK, failure by doctors and manufacturers to report adverse events associated with drugs and medical devices has serious repercussions: (1) it cripples the FDA's ability to pursue post-market safety issues, and (2) it prevents future patients from receiving accurate information about the risks they may be undertaking.
As conscientious consumers we need to do our part to fill the gap and to educate our doctors when necessary.
Thanks everybody.
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