Zicam Nasal Spray Warnings - Looking Behind the Headlines

Once in awhile a headline comes along that truly raises many more questions than it answers for empowered patients. This is one of them.

It's a perfect example of why patients need to be second guessing much of what they hear and read, and why even when we do that, it may only confuse us more. No easy answers. PLENTY of big questions.

The FDA has issued a warning against an over-the-counter cold symptom remedy called Zicam which is a homeopathic, zinc-based solution. In this case, the FDA claims that the nasal spray versions of Zicam have caused 130 people in 10 years to lose their sense of smell. The FDA has insisted Zicam nasal spray products may no longer be sold until they receive FDA approval.

Here's what I know about Zicam -- not much! But, I have used Zicam tablets (not nasal spray) when I first felt symptoms from a cold. I tried them after my sister insisted that Zicam had been a great boon to relieving her cold symptoms. Clearly many feel as if these products are helpful or the manufacturer could not stay in business.

Also, because the drug does not contain ingredients that would require FDA approval, Zicam products have always been sold over-the-counter, meaning we did not need a doctor's prescription to buy them. They don't contain any ingredients that require FDA approval.

Let's take a look behind this headline, because the details coming out now seem to suggest that there may be even bigger questions that aren't being asked or answered:

• Millions of dollars worth of this nasal spray have been sold for more than 10 years. The FDA cites 130 reports of problems through its MedWatch program since 1999. It also says that Zicam's manufacturer has received 800 problem reports. So why did it take so long to withdraw this spray from the market -- or -- why is it withdrawing a drug with so few reports (compared to the numbers of people who have used it?)
  
• 130 or even 800 problems in all these years is very few (unless, of course, you are one of the people affected) -- but I have to wonder if perhaps those patients had something else in common, too.... for example -- did they take the Zicam along with another drug that triggered that loss of smell? Or did they eat something that interfered? Or were they exposed to some other agent they breathed that, combined with the Zicam, made them lose that sense of smell? Did they forget to shake the bottle? Were they past the expiration date?

Sorry -- no answers -- just more questions:

• Why is the FDA clamping down on one over-the-counter herbal / homeopathic remedy? There must be many others with far more problematic outcomes to pick on. Or -- maybe there aren't? And if there aren't, then maybe these homeopathic remedies aren't as bad as the skeptics would like us to believe?
  
• Or maybe the FDA is picking a battle that will bring it some positive press because it has failed to protect us in so many other ways? If so, I find it interesting that they are picking on a product that never went through the approval process to begin with (it didn't need to). Why aren't they protecting us from truly dangerous drugs that they have approved?
  
• On the other hand, maybe FDA personnel are fearful (and rightfully so) that if they don't make a statement about Zicam nasal spray, with the information they have, then they would be accused of ignoring problems submitted to them?

Again -- no answers. Plenty of questions.

I also find it interesting that today, three days after the FDA edict about Zicam nasal sprays, I was able to walk into my local drug store and find plenty of Zicam boxes on the shelf for me to purchase. No warnings. So could it be that even this FDA edict has no teeth?

What can we patients learn? You know, I usually suggest we follow the money. If there is a money trail here, I don't believe we have any way of following it. It must be under the table.

In this case, then, it looks like the only lesson to be learned is that we must realize as patients that any substance we ingest, whether it's a prescribed drug, an over the counter drug, or an herbal "natural" remedy -- we must realize that there is a risk to taking it, no matter how easy it is to purchase.

And then we need to hope that in cases like this, where a remedy has been chastised / disapproved of / pseudo-hand slapped... we have to hope it's for all the right reasons.

Learn more about:

• Reading behind the headlines to understand medical news
• The definition of homeopathy or homeopathic
• Why we need to follow the money to understand medical headlines

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Learn more or join the conversation!
_{NEWSLETTER | FORUM | BIO | TWITTER}
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Photo by Trisha Torrey / from the shelf at my local Rite Aid