FDA warnings on antiseptics and allergic reactions
Skin antiseptics have been used by thousands of people for decades, but now they have been linked to extremely serious allergic reactions.
According to a new warning from the US Food and Drug Administration (FDA), antiseptic products containing chlorhexidine gluconate can cause rare but fatal allergic reactions. Because of this, manufacturers will now need to add a warning label to any over-the-counter products that contain chlorhexidine gluconate.
What is Chlorhexidine Gluconate?
Chlorhexidine gluconate is mostly used to clean skin before injections or surgeries. The FDA reported over 50 cases of anaphylaxis between 1969 and 2015 that were linked to the product, and in recent years, the number of cases has increased.
Current warnings about antiseptics
In 1998, the FDA issued the first health notice about medical devices that contained chlorhexidine gluconate. Today, several oral products have warning labels about the possibility of an allergic reaction, and soon all products containing chlorhexidine gluconate will come with a warning.
Health professionals should ask their patients about allergies before recommending certain antiseptic products.
Patients should make sure that they stop using products that contain chlorhexidine gluconate, if they think that they may be allergic. If you have an allergic reaction, seek medical attention immediately. Symptoms of an allergic reaction include swelling of the neck or face, hives on the skin, rashes and shock.
Alternatives to chlorhexidine gluconate include povidone-iodine, benzalkonium chloride, benzethonium chloride and parachlorometaxylenol.
Fast tracking FDA allergy recommendations
When the FDA make an update to a current product, they often prefer to fast track their updates. There are lots of companies to help with FDA 510k, such as http://www.fdathirdpartyreview.com/. FDA Third Party Review is accredited to review Medical Device Submissions on behalf of the FDA, as part of the Third Party Review Program, which means that important food and drug laws can be fast tracked for the benefit of the public.
The FDA Third Party Review program allows clients to fast track their 510k submissions, which reduces the time to market by around 100 days. This is very important to the FDA, as slower submissions could result in further serious allergic reactions that could have been prevented.
If you think that you may be allergic to chlorhexidine gluconate, make sure you speak to a health professional about your options. This could prevent a life-threatening allergic reaction.