mrindigo
17-06-2009, 06:21 AM
Shocker! A flu 'remedy' causing health problems.:rolleyes:
I am surprised the FDA actually did something about it. I doubt it's just a loss of a sense of smell. There's usually more issues with things like that than they let on.
June 16, 2009 -- The FDA today advised people not to use Zicam intranasal products that contain zinc, due to the risk of anosmia (loss of the sense of smell), which may be long-lasting or permanent.
The FDA's warning only applies to the following Zicam products:
* Zicam Cold Remedy Nasal Gel
* Zicam Cold Remedy Gel Swabs
* Zicam Cold Remedy Swabs, Kids Size
"Consumers should stop using these products immediately and should discard or return them," Deborah Autor, director of the FDA's Office of Compliance, said at a news conference.
All of the products covered in the FDA warning are sold over the counter, contain zinc, and are administered into the nose as a homeopathic treatment for colds. The FDA considers the products "misbranded," in part because the product labels don't warn about anosmia risk.
Autor noted that without the sense of smell, people "may not be able to detect dangers, such as gas leaks or something burning in the house, and may not be able to tell whether food is spoiled before eating," as well as having their quality of life diminished.
Zinc can damage receptors in the nose that are needed for smelling, notes Charles Lee, MD, a medical officer in the FDA's Office of Compliance.
The FDA has gotten more than 130 reports of anosmia in people using those products. Some of those people also reported a loss of their sense of taste, according to a warning letter the FDA today sent Matrixx Initiatives, Inc., the company that markets Zicam.
In that letter, which is posted on the FDA's web site, the FDA states that it "is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products." The FDA has asked Matrixx Initiatives to share those reports with the FDA.
The FDA has ordered Matrixx Initiatives to stop marketing the products without FDA approval, and to plan how to remove the products from the market, Autor said.
Matrixx Backs Zicam's Safety
Matrixx released a statement saying that "Matrixx Initiatives’ primary concern is consumer safety. Based on the FDA’s action, the company has suspended shipments of these products and will reimburse any customer desiring a refund.
However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products. Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.”
http://www.webmd.com/allergies/news/20090616/fda-some-zicam-cold-remedies-are-risky
I am surprised the FDA actually did something about it. I doubt it's just a loss of a sense of smell. There's usually more issues with things like that than they let on.
June 16, 2009 -- The FDA today advised people not to use Zicam intranasal products that contain zinc, due to the risk of anosmia (loss of the sense of smell), which may be long-lasting or permanent.
The FDA's warning only applies to the following Zicam products:
* Zicam Cold Remedy Nasal Gel
* Zicam Cold Remedy Gel Swabs
* Zicam Cold Remedy Swabs, Kids Size
"Consumers should stop using these products immediately and should discard or return them," Deborah Autor, director of the FDA's Office of Compliance, said at a news conference.
All of the products covered in the FDA warning are sold over the counter, contain zinc, and are administered into the nose as a homeopathic treatment for colds. The FDA considers the products "misbranded," in part because the product labels don't warn about anosmia risk.
Autor noted that without the sense of smell, people "may not be able to detect dangers, such as gas leaks or something burning in the house, and may not be able to tell whether food is spoiled before eating," as well as having their quality of life diminished.
Zinc can damage receptors in the nose that are needed for smelling, notes Charles Lee, MD, a medical officer in the FDA's Office of Compliance.
The FDA has gotten more than 130 reports of anosmia in people using those products. Some of those people also reported a loss of their sense of taste, according to a warning letter the FDA today sent Matrixx Initiatives, Inc., the company that markets Zicam.
In that letter, which is posted on the FDA's web site, the FDA states that it "is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products." The FDA has asked Matrixx Initiatives to share those reports with the FDA.
The FDA has ordered Matrixx Initiatives to stop marketing the products without FDA approval, and to plan how to remove the products from the market, Autor said.
Matrixx Backs Zicam's Safety
Matrixx released a statement saying that "Matrixx Initiatives’ primary concern is consumer safety. Based on the FDA’s action, the company has suspended shipments of these products and will reimburse any customer desiring a refund.
However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products. Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.”
http://www.webmd.com/allergies/news/20090616/fda-some-zicam-cold-remedies-are-risky