PDA

View Full Version : Adverse reaction reports to the FDA


aries81
Jan 12, 2011, 10:44 AM
Shouldn't dentists have to file adverse reaction reports to the FDA when a patient has an adverse reaction to a dental material? Most lie and say it's impossible to have an adverse reaction to a crown material or even an acrylic cement in someone who reports being allergic to acrylic.

I was wondering about this because I just found out that The FDA says Align Technology Inc. maker of the popular Invisalign "invisible braces," didn't tell the agency about several allergic reactions to the product.

I had an allergic reaction to a cement several years ago and I just checked the FDA website. I had even told the manufacturer about it. The adverse reaction report isn't there. I sent one in myself.

There should be a database about these things so that people can find out if a product is know to cause problems. Like I said, dentists won't admit that the materials can be harmful.

JudyKayTee
Jan 12, 2011, 11:57 AM
The FDA does not post every adverse reaction to every drug. At point I knew what percentage of people taking a prescription had to have a bad reaction before a warning is even put on a prescription. Anything can be harmful to someone who is allergic or sensitive but that doesn't mean anyone else (or everyone else) will have that same reaction.

aries81
Jan 12, 2011, 02:15 PM
"Anything can be harmful to someone who is allergic or sensitive but that doesn't mean anyone else (or everyone else) will have that same reaction." I know that. But dentists will almost NEVER admit that dental materials can cause an adverse reaction. If someone could go to the FDA website and see documentation of these things it would make things much easier on suffering patients. I was in severe pain and dentists would say things like "dental materials are totally insoluble so they can't cause reactions" or that I must be subconciously rubbing my tongue against my teeth.

JudyKayTee
Jan 12, 2011, 03:01 PM
"Anything can be harmful to someone who is allergic or sensitive but that doesn't mean anyone else (or everyone else) will have that same reaction." I know that. But dentists will almost NEVER admit that dental materials can cause an adverse reaction. If someone could go to the FDA website and see documentation of these things it would make things much easier on suffering patients. I was in severe pain and dentists would say things like "dental materials are totally insoluble so they can't cause reactions" or that I must be subconciously rubbing my tongue against my teeth.


I do not find it true that Dentists will almost never admit that dental materials can cause an adverse reaction. My Dentist has certainly looked closer at her work when I've had a problem, the same as a Physician.

I understand what you are saying but this is more a question for discussion that a Q&A post. Should the adverse reactions be available on a public site? I'd say no IF the patients are the people making the reports.

How to make Dentists more responsible (if that is your question) - I have no idea.