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New FDA Drug Safety Communication on chlorhexidine gluconate - Drug Information Update


2/2/17

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate.
Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the
Drug Facts labels <http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwMjAyLjY5NDk2MTAxJm1lc3NhZ2VpZD1NREItUFJE
LUJVTC0yMDE3MDIwMi42OTQ5NjEwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Mzg1Nzg2JmVtYWlsa
WQ9ZG9sc29uQGlkc29jaWV0eS5vcmcmdXNlcmlkPWRvbHNvbkBpZHNvY2lldHkub3JnJmZsPSZleHRyYT1NdWx0
aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
>. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels.

Patients and consumers should stop using the product that contains chlorhexidine gluconate and seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction. These reactions can occur within minutes of exposure. Symptoms include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.
Health care professionals should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. Advise patients to seek immediate medical attention if they experience any symptoms of an allergic reaction when using the products. Consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) when any previous allergy to chlorhexidine gluconate is documented or suspected.

For more information, please visit:

chlorhexidine gluconate <http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwMjAyLjY5NDk2MTAxJm1lc3NhZ
2VpZD1NREItUFJELUJVTC0yMDE3MDIwMi42OTQ5NjEwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Mzg1Nzg2Jm
VtYWlsaWQ9ZG9sc29uQGlkc29jaWV0eS5vcmcmdXNlcmlkPWRvbHNvbkBpZHNvY2lldHkub3JnJmZsPSZleHRyYT1NdWx0aXZhcmlhd
GVJZD0mJiY=&&&101&&&http://go.usa.gov/x9Htu?source=govdelivery&utm_medium=email&utm_source=govdelivery
>.

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