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Are Injectors And/or Physicians Required to Report Adverse Side Effects to Things Such As Botox?

I'm curious if it should be the patient, the physician, or both who report adverse side effects to the company and FDA?

Doctor Answers (9)

Reporting adverse side effects

+3

Any significant adverse side effects that's directly attributed to the Botox are reported. It's typically reported directly to the hotline established by the maker of Botox, Allergan. The detailed paperwork is then filled out and submitted as well. I think it's important for the manufacture and FDA to have as complete set of information as possible. This is how we can determine truly how safe each medication really is.


Los Angeles Plastic Surgeon
4.5 out of 5 stars 24 reviews

Injections and reporting

+2

I do not believe complications or side effects of product injection have to be reported but it is a good idea so statistics can be performed and outcome can be measured.

Steven Wallach, MD
Manhattan Plastic Surgeon
4.5 out of 5 stars 17 reviews

Botox adverse incident reporting

+2

I do not believe that we are legally mandated to report all incidents to the FDA.  If you had nausea or a headache after treatment, that could be a coincidence, as opposed to being causally related.  However, Allergan does maintain a 1-800 number and I personally do call them whenever a patient reports any concern that I feel is related to treatment itself.

Robert L. Kraft, MD
New York Plastic Surgeon
5.0 out of 5 stars 13 reviews

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Adverse Effects of Botox

+2

Hi anon.  That's a difficult question.  Yes, it would be prudent to report adverse effects of a Botox treatment, if we can verify that the side effect that the patient is experiencing is related to the treatment.  We've had everything from rashes to blackouts reported to us by patients.  In many cases, we cannot put the two together.  So, if a side effect is unusual and related to the treatment, then yes, we will report it.

Harold J. Kaplan, MD
Los Angeles Facial Plastic Surgeon
5.0 out of 5 stars 6 reviews

Botox side effects

+2

It is the responsibility of the physician (and the patient) to report to the company and in this case Allergan - however, it is not required. Most physicians are very good with this because it takes away or protects the physiciam in some way from liability because it is reported to the manufacturer. As well, I give credit to the comany because it is very good in handling this information. Remember that Botox is a very safe product and millions of patients have received it. It has at least 22 FDA indications and the list of problems that it treats is growing yearly. If it makes you feel better, call them as well and report directly to Allergan.

Hratch Karamanoukian, MD, FACS
Buffalo General Surgeon
4.5 out of 5 stars 7 reviews

Who reports side effects about Botox

+2

No one is "required" to do it, but it's good practice to report anything out of the ordinary, by both the physician and the patient. The report is made directly to Allergan, who makes Botox, and they have a specific hotline for it. They gather the reports and then they give everything directly to the FDA. Anything gathered by the company as "adverse" has to be reported by them to the FDA. The FDA doesn't require (or frankly want) physicians or patients calling in to them with adverse effects, though you can do so if desired. But it's much easier to just call Allergan directly, and then they give everything to the FDA as required.

F. Victor Rueckl, MD
Las Vegas Dermatologist
4.5 out of 5 stars 8 reviews

Report severe or unusual adverse events

+2

Both the patient and/or the doctor should report any patient with a severe or unusual adverse event.  Simple, routine adverse events such as swelling or bruising that may not be specific to that products are usually not reported. 

Daniel Yamini, MD
Los Angeles Plastic Surgeon
5.0 out of 5 stars 16 reviews

FDA adverse reaction reporting

+2

Both consumers and medical professionals can report adverse reactions to the FDA. Google "FDA adverse reaction reporting", or click the link below.

Joseph Mele, MD
Walnut Creek Plastic Surgeon
4.5 out of 5 stars 7 reviews

Reporting Adverse Events

+1

First off, rest assured, Botox is a drug with millions of patient treatments and when used cosmetically, nothing but temporary, nuisance side effects have ever occurred. 

But, in short, no, physicians are not required to report adverse events.  There are a number of adverse events that are known to occur with each end every drug.  Should a physician have a patient experience one of these and it is not a grave issue, it is unlikely that he/she will report it.  It really serves no purpose if the side effect is already well known.  If it is a novel or especially severe side effect, then a responsible physician would report it to the manufacturer and from there it would go on to the FDA. 

Mandatory reporting does exist for certain infectious diseases for obvious reasons.

Louis W. Apostolakis, MD
Austin Facial Plastic Surgeon
5.0 out of 5 stars 19 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.