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. In another, there are less severe but still serious problems with lid closure.

I am very concerned about this. If I've personally heard of two in a row, make no doubt there's more of it happening out there somewhere. Furthermore, LID PARALYSIS AND INCOMPLETE LID CLOSURE ARE NOT LISTED AS RISKS anywhere that I can find. Allergan's site lists ptosis, dry eye and corneal inflammation as side effects. The FDA site lists 'droopy eyelid' lasting a few weeks. This is more serious than any of those, however.

DOCTORS, please be on the alert for this and by all means file a Medwatch report or make sure your rep does. If any of your patients experience this please make sure they learn about ALL available remedies including things like Tranquileyes moisture goggles which will help hold their lids closed at night. If that's not suitable for your patient for some reason we can help you find alternatives such as eyelid-friendly tapes or sleep masks.

PATIENTS, if any of you reading this have experienced this complication, please urge your doctor to report it to the FDA. Whether or not your doctor undertakes to do so, please also file a Medwatch report on your own.

Here is the link to the FDA site for adverse event reporting.

As we witnessed so recently with LASIK, failure 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.

(Note that after it was widely reported that only 140 "consumer complaints" had been received by the FDA about LASIK in 8 years, more than 200 more complaints were filed in less than a month - uncomfortable testimony to the FDA's failure to make their reporting system known and to physicians' and/or manufacturers failures to report poor patient outcomes.)

As conscientious consumers and professionals let's do our part to make things safer for future patients!

Thanks everybody.