FDA Investigating Radiation Overexposures During Perfusion CT Scans
Published: October 9th, 2009 • Comments: 6
The FDA has issued a statement expressing concerns that some CT brain perfusion scans may be giving patients overexposure to radiation. The regulatory agency indicates that they are working to gather more data about the situation and to understand the potential public health impact.
According to a Safety Alert issued on Thursday, the FDA indicates that several patients at an unnamed facility received radiation overdoses from multi-slice CT machines. More than 200 patients were exposed to eight times the normal amount of radiation while receiving CT brain perfusion scans for diagnosis and treatment of strokes. The incident has raised concerns that there may be a more widespread problem with radiation overexposure associated with the CT scans.
The FDA indicates that some patients suffered from hair loss and erythema as a result of the radiation overdoses. Erythema is redness of the skin similar to sunburn and is a common side effect of radiotherapy treatment. The facility has notified all patients who received overexposure.
The warning said that the agency is concerned that “this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure.” The agency said the magnitude of the overdoses and their effects on the patients were significant, and if similar incidents are happening at other facilities, they may be going unrecognized and unreported, leading to long-term overexposure for patients.
After gathering more data about the situation, the FDA indicates that a determination will be made about whether there are more widespread risks and the need for any actions.
In the interim, regulators are advising that all facilities performing CT scans should review their CT protocols and pay close attention to dose indices displayed on the machines’ control panels. Operators should “make sure the values displayed reasonably correspond to the doses normally associated with the protocol,” the warning stated. “Confirm this again after the patient has been scanned.”
The FDA is asking that any incidents of CT overexposure or other adverse CT events be reported to FDA’s MedWatch program.
Comment by Becky on 10 October 2009:
I had a brain scan and now have hair loss in an inch and one half ribbon band form ear to ear around the back of my head. I wonder if it was from the CT scan.
Comment by Jean on 10 October 2009:
I have had 6 Brain/Head MRI/Ct’s since Feb 2009. In March I began to notice an unusal amt of all-over hair loss. It has become progressively worse and am now taking medication for this. How do we know safe level of radiation for testing and then how does an individual receive documentation to validate any suspicions?
Comment by Stephanie on 19 October 2009:
I had c-t scan done afew months ago. Since then i have had hair loss, headaches, nauseu,and weakness. I don’t feel myself. I ‘ve had to turn to pain killers to not feel the pain, My doctor won’t prescribe them so i have to buy them off the streets. I take these narcotics just to feel normal. I was normal before i had the c-t scan done. Now i have had to quit my job. What do i next, any opinions?
Comment by sandy on 23 October 2009:
Becky, I have the exact same problem as you do, it seems. I had a CT scan for possible stroke on September 9, 2009. About 2 weeks later my hair came out in the same pattern as yours did. You are the only one I have heard of with my problem as of yet. My hair is still thinning all over, but I am not bald except over my ears. Just to let you know you are not alone. I hope there is a way for us to get in touch with each other.
Comment by Sue on 5 November 2009:
I had a CT scan of my head and neck…..three days later my hair started falling out….something it has never done before…It’s now been three weeks and I’m monitoring the loss on a daily basis just incase my doctor thinks I’m crazy.
Comment by barbra on 12 November 2009:
my hair is faLLING OUT AND I HAD A CT ON MY UPPPR BODY.THERE IS HAir in the kitchen.bathroom and hall floors. sink is full and so are bushes