What do Zicam, Ephedra and Hydroxycut have in common?—and no, you can’t look at side-by-side pictures for this one. If you’ve been following the news, turns out they have a lot more in common than you’d think. All three…
and…
And while each of these has been yanked from the market, those of their ilk that are still on the market now need some babysitting (i.e., tighter regulation and increased safety testing).
The bottom line is that people think “natural” equals “safe.” Unfortunately, that’s just not always true. Something can be natural and still harmful—Poison Ivy, anyone? And the food industry is renowned for giving new meaning to “natural”. Check out the Jelly Belly site and you’ll see the superfruit mix is: Naturally Sweetened, High in Antioxidant Vitamin C, Made with Real Fruit Juices and Purees, and have Colors from Natural Sources. Great—but I won’t be getting my USRDA of vitamin C from ‘em.
Funny thing about your sense of smell. Unlike vision or hearing, you don’t really think about your sense of smell until a specific circumstance: that early morning whiff of coffee brewing, an aromatic stroll through a rose garden, the powdery scent of a baby. Or the unmistakable and intrusively pungent odor of a skunk…These are the scents that some former Zicam users are alleging they can no longer smell—because of Zicam.
If you’ve ever wondered what the top 3 challenges might be for individuals who suffer from smell loss, here they are:
As mentioned in some of the examples above, we gain pleasure from many different scents. According to the SenseofSmell.org, humans are capable of recognizing 10,000 distinct odors. Additionally, we recall smells with a 65% accuracy after a year, while the visual recall of photos sinks to about 50% after only 3 months. It’s no wonder we’re able to recall fond memories simply by recognizing a familiar scent.
Zicam users who’ve allegedly found themselves without a sense of smell have to deal with another “loss”: the loss—or lack—of treatment options.
One thing you immediately realize upon reading a July 10th article from HealthDay Reporter on loss of smell and a possible new treatment for it is that restoring the sense of smell is not an easy task—few treatment options exist and those that do exist are not a sure bet.
The article, however, points to a potentially new treatment option found in a drug once used to treat asthma. The drug, theophylline, showed some initial promise in a recent study done by Dr. Robert Henkin, director of the Center for Molecular Nutrition and Sensory Disorders in Washington, D.C.
The study looked at 312 patients who were diagnosed with hyposmia (loss of smell) over a seven-year period. After being treated with theophylline, over 50% of the participants in the study reported improved sense of smell; more than 20% reported their smell had returned to normal.
Get a Whiff of Zicam. Oh wait, maybe you can’t. At least that’s what’s at the heart of the latest Zicam news. No, it’s not a class action yet—but it could be. And it wouldn’t be the first one. At issue are 3 Zicam cold remedies that cause a loss of sense of smell—a condition known as anosmia. As if the cold wasn’t enough of a problem.
In 2005 more than 300 people filed a class action lawsuit against Matrixx, the makers of cold remedies marketed under the name Zicam, alleging the zinc nasal spray caused a loss of sense of smell and taste. Matrixx settled the suit in 2006 for $12 million.
This week, on June 16, 2 years and 130 adverse event reports later, the FDA released a public health advisory urging consumers not to use the Zicam cold remedies, for the same reasons the lawsuit was brought in 2005.
The products named in the FDA’s advisory are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product). What part of this didn’t Matrixx get the first time round?
MySpace Ain’t Your Space. What would you do if you were forced to give your employer your ID and password to an online group you had created with the express purpose of venting your frustrations about your employer? Well, 2 waiters in New Jersey who were faced with that very situation filed a class action lawsuit. And they won.
Restaurant managers who worked at Houston’s in Hackensack, NJ, were fined by a federal jury for surreptitiously monitoring employees’ postings in a MySpace gripe group. The jury ruled that the managers had violated state and federal laws designed to protect privacy of internet communications. The jury awarded the waiters a total of $3,400 in back pay and $13,600 in punitive damages.
BMW: Sheer Driving Pleasure? (if you excuse the faulty subframes). If you or someone you know owns a fourth-generation 3-series model BMW—say the E46—you will be happy to hear there is a settlement pending in the 2006 class action suit against the automaker. So far, BMW has agreed to begin inspections and repairs of potentially faulty subframes in these models.
Currently the settlement is only valid for US residents, and no recall is planned. BMW customers with questions can visit www.E46subframeclassactionsettlement.com.
That’s it for this week. See you at the Bar…
Matrixx is preparing for a new wave of lawsuits from consumers alleging that certain Zicam products have caused anosmia, or loss of smell and taste, according to the June 19, 2009 Arizona Republic.
In early 2006, the company settled one round of 340 lawsuits for $12 million to avoid the legal costs of defending each suit, company officials told the Republic.
On June 16, 2009, the FDA warned the public to stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size because they could cause “long-lasting or permanent” loss of smell.
The agency noted receiving 130 reports since 1999 from consumers and doctors. The FDA learned that Matrixx had received another 800 reports during an inspection of the company in May, and claims that Matrixx was required to turn them over to the FDA under a 2007 regulation.
The agency also sent Matrixx a warning letter saying 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 Autor, director of CDER’s Office of Compliance, in the advisory to the public.
“The FDA has asserted that the Company is in violation of its regulations by failing to file a new drug application for its Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs and that those products are misbranded under their regulations for failing to adequately warn of risks,” Matrixx said in a June 16, 2009 press release.
“The Company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace,” Matrixx wrote.
“These products constituted approximately 40% of the Company’s net sales in 2009,” the release noted.