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The Food and Drug Administration issued a warning on June 16, 2009 for 3 Zicam nasal merchandise, together with Zicam Cold Remedy Nasal Gel. According to the FDA warning, the favored chilly cures might pose severe dangers to customers. One such threat is the lack of odor (anosmia) – a severe and probably everlasting situation. The FDA mentioned that it had acquired greater than 130 experiences of anosmia related to Zicam Cold Remedy Nasal Gel and two different Zicam merchandise, and it is potential that tons of of further instances have been reported to Matrixx Initiatives, Inc., which owns Zicam.
Consumers who're in possession of Zicam Cold Remedy Nasal Gel are urged to discontinue use instantly.
Reporting an Adverse Event
Zicam Cold Remedy Nasal Gel is an intranasal product, which implies it's administered straight into the nostril. It is one among Zicam's three over-the-counter, zinc-containing intranasal merchandise – all of that are marketed as decreasing the severity and size of the widespread chilly in youngsters and adults. However, this declare will not be backed by the FDA and, actually, in violation of FDA rules.
The FDA recommends that customers who've skilled lack of odor after utilizing Zicam Cold Remedy Nasal Gel contact a doctor and report the occasion to the company's MedWatch program. In its well being advisory, the FDA mentioned that many instances of lack of odor occurred with the primary dose of Zicam, however it might occur with later doses as properly.
Zicam Problems Cited by the FDA
In a letter to Matrixx, the FDA acknowledged that:
– Zicam Cold Remedy Nasal Gel and two further zinc-containing Zicam merchandise are usually not typically acknowledged as secure and efficient
– The merchandise are marketed with out FDA approval
– The merchandise don't comprise ample warnings concerning the threat of lack of odor and are misbranded
– In addition to lack of odor, some people have additionally reported experiencing lack of style after utilizing zinc-containing Zicam merchandise
– Other extensively used intranasal merchandise – ones which can be authorized by the FDA – are safer and fewer uncomfortable side effects are reported
Contact a Lawyer
The lack of sense of odor can have devastating results, notably in youngsters and those that work within the meals trade. Those who've suffered this aspect impact after utilizing Zicam Cold Remedy Nasal Gel might be able to take authorized motion in opposition to the product producer. Learn extra about your authorized rights by contacting a medical lawyer who has expertise in these instances.
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