FDA Issues Warnings on Three Zicam Intranasal Zinc Products
For Immediate Release: June 16, 2009
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Intranasal Zinc Product Linked to Loss of Sense of Smell
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.
"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."
People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.
"Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold," said Deborah M. Autor, director of CDER's Office of Compliance.
Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
For more information, visit Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size
View the FDA News Release
If you or a family member has suffered from these products in any way, please schedule a free confidential consultation with one of our lawyers by calling us at 704-376-1911 in the Charlotte area or toll free at 1-800-977-3077, or filling out our intake form on our Contact Us page.
Gadolinium-based Contrast Agents
Several recent reports in the medical literature suggest an association between Gadolinium and the disease Nephrogenic Systemic Fibrosis (NSF), and the FDA has issued an alert regarding this potential widespread problem.
Gadolinium is one of the compounds in the contrast dye used to enhance MRI studies. It now seems that Gadolinium-containing dyes can cause NSF, previously known as nephrogenic fibrosing dermopathy (NFD). Patients, particularly those with serious renal or kidney disease, can develop this debilitating and frequently fatal disease within days or months after have an MRI study with a contrast dye containing Gadolinium. Contrast dye with Gadolinium is also used during an MRA or magnetic resonance angiography.
If you or a family member have developed NSF following an MRI or MRA study, please schedule a free confidential consultation with one of our lawyers by calling us at 704-376-1911 in the Charlotte area or toll free at 1-800-977-3077, or filling out our intake form on our Contact Us.
Trasylol Heart Surgery Drug
The FDA recently announced that Bayer, the maker of Trasylol (aprotinin), has suspended marketing of this heart surgery drug used to help control bleeding. In October 2007, the FDA was notified that a Canadian study of the drug had been halted after early data appeared to suggest that the drug, Trasylol, increased the risk of death. Many patients do not even know they received the drug during heart surgery, but it has since been associated with increased risk of heart attack, stroke, kidney failure and blood clots following surgery.
Based on other studies it appears the manufacturer, Bayer, was aware of problems with Trasylol long before it agreed to the FDA request to suspend marketing. There are some estimates that as many as 22,000 deaths may be related to the use of aprotinin.
If you or a family member suffered a heart attack, stroke, kidney failure, or some form of blood clot following heart surgery such as coronary artery bypass grafting (CABG), please schedule a free confidential consultation with one of our lawyers by calling us at 704-376-1911 in the Charlotte area or toll free at 1-800-977-3077, or filling out our intake form on our Contact Us page.
