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We first heard about ZIcam on October 9, 2000. That's when the a PR firm touted a study in the ENT (Ear, Nose & Throat) Journal showing that a zinc nasal gel shortened the duration of the common cold.
At that point zinc lozenges had already established themselves in the marketplace. That's because in the 1980s a stubborn little girl with leukemia wouldn't swallow her zinc tablet. Instead, she sucked on it and her cold symptoms disappeared almost overnight.
This prompted her physicians to investigate whether zinc could be effective against the common cold. Studies since then have produced mixed results--some showing benefit and others showing none.
Fast forward to Zicam. Instead of sucking on a lozenge that some people found nauseating, consumers were offered the possibility of squirting or swabbing zinc gluconate straight into their nostrils.
It wasn't long before people were telling us about this wonderful new cold remedy. But by 2005 we began to hear about the dark side of Zicam.
Some people were complaining that using Zicam in their noses impaired the sense of smell: "My sister used Zicam and immediately lost her sense of smell. Her doctors say she will be lucky to get 30 percent back. After 5 weeks, she has barely any sense of smell. She is a medical practitioner and followed the directions explicitly."
Before too long, there were published reports of people losing their sense of smell following the use of zinc nasal gel (Laryngoscope, Feb. 2006). The manufacturer of Zicam countered that such reports were "completely unfounded and misleading."
Consumer Reports alerted the public in January, 2007: "Studies with animals and case reports suggest that nasal zinc may cause loss of smell, possibly permanent. Last year we [CR] unearthed more than 200 complaints to the Food and Drug Administration about an impaired sense of smell, taste, or both after using zinc nasal products."
Meanwhile, Matrixx Initiatives, Inc., the maker of Zicam, settled a class action lawsuit in 2006 with over 300 people for $12 million. Despite the settlement, the company denied that its product was responsible and instead pointed a finger to cold viruses as the culprit.
Now there is new leadership at the FDA. Commissioner Margaret Hamburg, MD, took decisive action only weeks after being confirmed in her new job. She promised to be a tougher cop: "We've been more aggressive in enforcement actions, where people's health is at risk."
The agency backed this claim up by issuing a caution to consumers to stop using Zicam Cold Remedy Nasal Gel and Swabs. In addition, on June 16, 2009, the FDA sent Matrixx a letter warning that the products pose a serious risk to consumers and demanding that the company correct its violations of FDA rules.
This quick action by the new leadership team at the FDA should bolster confidence in the agency's determination to protect the public health. Transparency and decisive action have been missing from this watchdog agency for far too long. Action on these Zicam nasal products is a welcome first step.
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So if the FDA is getting tough, why are the Zicam products still prominently displayed in my local pharmacy with no warning notices? I'm going to print this article and take it to the pharmacist.
To me, this is NOT "our" government looking after us but the government doing the bidding of the AMA and pharmaceutical manufacturers.
As I understand it, over four million people used these nasal swabs. AND it was the FIRST medication that ever stopped or reduced the common cold. At least for me and everyone I knew who used them. Colds didn't get worse (they STOPPED if caught early enough). Colds didn't turn into required $100 doctor visits where the hour late doctor would see you for two minutes then give you a prescription for some unknown $200 medication plus a decongestant.
I also understand, out of four million plus, 500 people (a percentage that is a close to zero as you can get) "reported" ANY change in the ability to smell. And more than half of the 500 "jumped on" the potential gravy train after reading about the class action law suit. As it turned out none of those people received a dime. There is some justice.
While hundreds of others received large settlements because of a judge's order that an impractical clinical "smell ability test" was not required. The person only had to be one of the first to complain and had to say they either totally lost their ability to smell or it was temporarily disrupted. A quick way to make a LOT of money from a big company. Zicam did EXHAUSTIVE studies and found NO effect in spite of testing thousands of people giving them nasal swabs EVERY DAY for months. THAT is why they kept them on the market. They settled the lawsuit to avoid further legal expense. If they had known a new imperial AMA-prone commissioner was coming, they would have continued the case and, I"m sure, won.
The cough drops do nothing for me. Only the swabs. When I heard this news, I bought up all I could find that had not been removed from store shelves (perhaps a year's worth). So the AMA won again. The AMA is NOT on our side but many people know that. I do.
Much like removing the drug also used to make "meth" illegal drugs from cold pills. That also STOPPED their helpfulness to me. They are now no better than sugar pills.
I just read an FDA panel voted to remove two prescription pain killers from the market after reports of 110 overdose deaths (suicides) over a period of years out of millions of people who take the drugs. My doctor spent years finding these prescription pain killers that provide me relief from the broken back I suffered as well as the crushed cheek bone. A total of 19 surgeries. With these unique pain killers I can lead a normal life acting and feeling normal and almost NO pain! Other medications work but also turn me into a vegetable.
Would the 110 overdoses have found some other drug to commit suicide with? Of course. There are hundreds. This action will do nothing except put people like me back to being a mostly home bound vegetable instead of working and leading a normal life. Was there an "invitation for public comment"? Perhaps but it was WELL hidden. Too late now. I'm preparing to quit my job (again) and give up this time.
It seems like the FDA and AMA look for anything that works and keeps people out of doctor's offices then find an excuse to ban them. The comical phrase "we're from the government and here to help you" is never more true than with the FDA.
Non-prescription shelves are filled full of worthless drugs because of "our" government "protecting" us plus not allowing various prescription drugs that are perfectly safe if taken as prescribed. Having almost been killed by two doctors who "guessed" at drugs for me, the knowledge of the doctor is most important. I will now take nothing until I have read about it thoroughly and agree with the doctor.
I used Zicam for the first time last Feb. I thought it helped somewhat but it definitely affected me in other ways. Mainly, in regards to food, nothing sounded good to me anymore. My doctor told me months later it was probably because I couldn't smell the food. I am pretty much back to normal but wonder how many people experienced something like this and didn't say anything.
I have had a lot of problem with leg cramps resulting from meds, mostly those for lowering cholesterol. I also have had a reaction like this to an antibiotic. This past week, I was taking the Zicam melts for a cold as directed every 3 hours. That night, I got pains in my legs and I think it was from the Zicam - seems like that was what caused the pain as I have not done anything else different...Wondering if anyone else has had that happen.
Has anyone or does anyone know were I can find information about an individual liability court ruling? It's for a paper. Please let me know.