http://www.yourlawyer.com/topics/overview/triaminic_vapor_patch Sat, 21 Nov 2009 15:17:39 -0800 pixel-app en http://www.yourlawyer.com/articles/read/11906 Wed, 21 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11906
The over-the-counter cough suppressant works through inhaled vapors to loosen up congestion. More than 50 million patches have been sold in the United States since they first came on the market in 2000, said Julie Masow, a Novartis Consumer Health spokeswoman.

There have been eight adverse events with the patch, all involving ingestion, Masow said. In one case, a child swallowed the patch and had a non-fatal seizure. The company and the Food and Drug Administration announced the voluntary recall Monday.

Other reactions included nausea, vomiting, and a burning sensation in the mouth.

The FDA received only one adverse-event report involving the seizure, and has requested information about the others from the company, an agency spokeswoman said.

The patch, which comes in cherry and menthol scents, includes menthol, eucalyptus oil and camphor. It is supposed to be applied to children's neck or chest, so that they can inhale the vapors.

Problems occurred when children accidentally ate the patches.

Camphor can be fatal when swallowed, said Michael Cohen, president of the Institute for Safe Medication Practices, an independent watchdog group that investigates medication errors. He said parents should be careful about properly using products with camphor in them.

"Kids think these patches are stickers and they start chewing on it," Cohen said. "These patches are placed on the neck and chest, and they're easy for kids to reach."

In December, the FDA started investigating the safety of all patch medications, particularly when used with heat, after more than 100 deaths involving a pain-medication patch.

Those with the Triaminic patch can return it to the place of purchase for a full refund.
]]> http://www.yourlawyer.com/articles/read/11897 Tue, 20 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11897
The recalled patches include both the mentholated cherry and menthol scented versions sold by Novartis Consumer Health. They should be discarded or returned to the place of purchase for a full refund, the company said.

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as 2 to allow vapors to reach the nose and mouth. The company said the placement of the patches can allow children to remove and place them in their mouths.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, headache, nausea, vomiting or seizure. In the single reported case of a seizure, the child recovered that same day, the company said.

Other complaints associated with the patches include reports of blistering, bruising, scarring, hyperactivity and depigmentation, the company said.

Parents and other consumers with questions should contact Novartis at (800) 452-0051 or visit http://www.triaminic.com, the company said.

Any adverse reactions associated with the patches should be reported to the Food and Drug Administration through the agency’s MedWatch program, either online at www.fda.gov/MedWatch/report.htm or by telephone at (800) FDA-1088.

Novartis said it has sold more than 50 million Triaminic Vapor Patches since introducing them in 2000. They are sold through pharmacies and retail stores.]]> http://www.yourlawyer.com/articles/read/11899 Tue, 20 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11899
Vapor Patch is widely available in the US and sold over the counter.

The US Food and Drug Administration has registered the recall, Novartis said.
]]> http://www.yourlawyer.com/articles/read/11896 Mon, 19 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11896
Consumers who have Triaminic Vapor Patches should stop using them immediately. There have been multiple reported complaints received, including seizures. Novartis Consumer Health's number one priority is the safety of the consumers who use our products and, therefore, is taking this precautionary action.

All lots are being recalled in both product lines of mentholated cherry scent and menthol scent. Triaminic Vapor Patch contains camphor, eucalyptus oil and menthol.

The reported adverse events associated with swallowing products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as seizures.

The recall is being conducted with the knowledge of the FDA.

Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Multiple patches can be applied. Once applied, the patch would be within close reach for a child to remove and place in his/her mouth. The Vapor Patch is a topical cough product applied externally and not for oral consumption.

The product is sold nationwide over the counter at pharmacies and retail stores.

This recall affects only the Vapor Patch. Consumers should immediately discontinue use of this product and return it to their point of purchase for a full refund or discard it. Consumers requiring more information about this recall can contact Novartis Consumer and Professional Affairs Call Center at 1-800-452-0051 or visit http://www.triaminic.com.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from http://www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].]]> http://www.yourlawyer.com/articles/read/11900 Mon, 19 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11900
The Swiss drug company told consumers to stop using its Triaminic Vapor Patches immediately. The recalled patches include both the mentholated cherry and menthol scented versions sold by Novartis Consumer Health. They should be discarded or returned to the place of purchase for a full refund, the company said.

Health Canada issued its warning on May 30, and Novartis director of communications Jason Jacobs said the recall in Canada "happened very quickly."

The patches contain camphor, eucalyptus oil and menthol and are meant to be applied to the chest or throat of children as young as two to allow vapours to reach the nose and mouth. The company said the placement of the patches can allow children to remove and place them in their mouths.

Ingesting camphor or eucalyptus oils can cause a burning sensation in the mouth, headache, nausea, vomiting or seizure. In the single reported case of a seizure, the child recovered that same day, the company said.

Other complaints associated with the patches include reports of blistering, bruising, scarring, hyperactivity and depigmentation, the company said.

Parents and other consumers with questions should contact Novartis at 800-452-0051 or visit http://www.triaminic.com, the company said.

Any adverse reactions associated with the patches should be reported to health officials.

Novartis said it has sold more than 50 million Triaminic Vapor Patches since introducing them in 2000. They are sold through pharmacies and retail stores.
]]> http://www.yourlawyer.com/articles/read/11901 Mon, 19 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11901
FDA is advising consumers who have used the product and have concerns or questions to contact their physician or health care practitioner. In addition, the company is advising consumers to either discard or return the product to their point of purchase for a refund.

Triaminic Vapor Patch contains camphor, eucalyptus oil, and menthol. The reported side effects from swallowing or chewing on products containing camphor or eucalyptus oils vary from minor symptoms, such as a burning sensation in the mouth, headache, nausea and vomiting, to more severe and life-threatening reactions, such as seizures.

Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Multiple patches can be applied at one time. Once applied, the patch would be within close reach for a child to remove and place the product in his/her mouth. The Vapor Patch is a topical cough product applied externally and is not for oral consumption.

The product is sold over the counter at pharmacies and retail outlets nationwide.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone (1-800-FDA-1088), or by returning the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm, by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax (1-800-FDA-0178).]]> http://www.yourlawyer.com/articles/read/11792 Tue, 30 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11792
Triaminic Vapour Patch contains camphor, eucalyptus oil and menthol. The reported side-effects from swallowing products containing camphor or eucalyptus oils vary from minor symptoms such as burning sensation in the mouth, headache, nausea and vomiting to more severe and life-threatening reactions such as seizures.

Health Canada is aware of one adverse reaction associated with the use of Triaminic Vapour Patch. The adverse reaction involved a child who had a seizure after chewing on the patch.

Triaminic Vapour Patch is advertised as a cough suppressant for children two years of age and older. The directions on the label indicate that the patch is to be applied to the throat or chest to allow the vapours to reach the nose and mouth. Once applied, the patch would be within close reach for a child to remove and ingest. An additional risk is the product's cherry scent, which could also lead a child to chew or swallow the patch.

The product is sold over the counter as a natural health product at pharmacies and retail outlets in Canada. A recall of the product will be initiated by the distributor. Consumers should discontinue use of this product and return it to the point of purchase.

Consumers who have used the product and have concerns about their health should contact their physicians or health care practitioner.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction with these or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 866-234-2345
Facsimile: 866-678-6789

Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca]]> http://www.yourlawyer.com/topics/overview/triaminic_vapor_patch Tue, 30 May 2006 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/triaminic_vapor_patch Triaminic Vapor Patch Removed from Market On June 19, 2006 Novartis AG, the manufacturer of the Triaminic Vapor Patches recalled the patches, after a child experienced a seizure after chewing on the cough-suppressing vapor patch. The current recall includes the mentholated cherry and menthol scented versions. Novartis has instructed all individuals who currently have the patch to either discard them right away or return them to the establishment they were bought, for a full refund.

Triaminic Vapor Patches is made up of menthol, camphor, and eucalyptus oil. Both of these substances are designed to be applied to the chest or throat of children as young as 2 to allow vapors to reach the nose and mouth. Each patch contains approximately 4.7% of camphor and 2.6% of menthol. Triaminic Vapor Patches are used to temporarily relieve coughs due to minor throat and bronchial irritations.

Side Effects
If Camphor or eucalyptus oil is eaten an individual can encounter a burning feeling in the mouth, nausea, headaches, vomiting or seizure. Other inhalation ailments can consist of blistering, scarring, bruising, hyperactivity and depigmentation, the loss of pigment from the skin, mucous membranes, hair, or retina of the eye.

Canadian Warning
On June 5, 2006, Health Canada warned consumers not to use Triaminic Vapour Patches due to potential side effects. Triaminic Vapor Patches was introduced to the market in 2000. Since then an estimated 50 million patches have been sold. Triaminic Vapor Patches can be purchased at retail stores or pharmacies.

Free Lawsuit Case Consultation
If your child accidently ingested a Triaminic Vapor Patch and suffered a seizure or any other injury, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>