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Posts Tagged ‘Add new tag’

F.D.A. Warning for Zicam Cold Remedy

Wednesday, June 17th, 2009

The Food and Drug Administration today issued a warning to consumers to discontinue the use of the nasal cold remedy Zicam because it may result in the loss of smell.  The products are:
    –Zicam Cold Remedy Nasal Gel
    –Zicam Cold Remedy Nasal Swabs
    –Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

While Matrixx Initiatives, manufacturers of Zicam, maintains that their product is safe, as a result of the F.D.A warning, they issued a press release today stating they are voluntarily recalling all Zicam products.

The F.D.A. has received rover 130 reports of anosmia, or loss of smell, from consumers with as little as one dose of the nasal gel.  The reports date back to 1999 and include both temporary and permanent loss of smell.

Zicam isand is distributed as a homeopathic remedy. As such, they  did not need approval from the F.D.A. to sell the product.   However, according to the New York Times, Matrixx has settled over 340 claims totalling over $12 million for loss of smell and has over 800 reports of loss of smell but F.D.A. has not seen those reports.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER)

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms. 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.”

Matrixx has asked consumers to discard any unused product or request a refund on line at www.ziam.com or by calling 1-877-942-2626.

NTSB Focuses on Fatigue-Related Accidents

Wednesday, March 18th, 2009

In conjunction with National Sleep Awareness Week last week, the National Transportation Safety Board (NTSB) has once again issued its commitment to improving highway safety by eliminating fatique-related auto, truck, bus and airline accidents.

According to NTSB Board Member Deborah Hersman,

“Fatigue in transportation presents unnecessary risks to the traveling public. Fatigue can impair a person behind the wheel or at the helm much like alcohol or other drugs. We must ensure that as much as possible is being done to protect our transportation system from the insidious effect of human fatigue.”

For a long time now the NTSB has included fatique and hours-of-service on their Most Wanted List of highway safety improvements.  It is the intent of the Board to continue to work with all members of the transportation industry to study the effects of fatique, rest requirements and driver alertness to prevent future injuries and death.

Acai-berry Claims Being Investigated

Tuesday, January 13th, 2009

According to the Orlando Sentinel, three Florida companies selling acai-berry supplements as weight loss, anit-aging and cancer curing products are being investigated by Florida’s Attorney General: South Florida Nutrition Inc. (SFL Nutrition),  GlobalNet Pharmacies and Aton Solutions. 

According to the Attorney General’s office, after signing up for a 14-day free trial, consumers appear to be locked into recurring monthly orders (at $80 per month) that they cannot cancel, are unable to get refunds as promised or even reach a customer service representative.   

While in a 2006 test at the University of Florida showed the acai-berry killed “cultured leukemia cells”, researchers say there is no proof that the acai-berry supplement can cure cancer.  And Stephen Barrett, founder of Quackwatch.com, a consumer health advocacy site, said

“ there’s little or no scientific evidence to support claims that supplements containing antioxidants prevent cancer and other illnesses or promote weight loss.’

If you wish to file your own complaint, contact the Florida Attorney General’s cosumer protection division.