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FDA targets unapproved prescription cold meds
March 2nd, 2011
03:40 PM ET

FDA targets unapproved prescription cold meds

Companies that make, distribute or market unapproved prescription cough, cold and allergy medications were put on notice Wednesday by the Food and Drug Administration that their products can't be legally marketed in the United States.

The FDA says the safety, effectiveness and quality of 27 active ingredients in approximately 500 unapproved drugs have not been evaluated by the agency. Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said the agency doesn't know what's in these drugs or how they were made.

"Removing these unapproved products from the market will reduce potential risks to consumers, " Autor said. "There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products available to treat cough, cold and allergy symptoms, so we expect little or no negative impact on consumers from the removal of these unapproved products."

Autor says consumers could be at greater risk with these products than with FDA-approved prescription drugs and over-the-counter products. She says some of them contain a combination of the same types of drugs, raising the risk of over-medication. Some are marketed as time-released but may release active ingredients to slowly or too quickly. "We do not know if they're safe. We do not know if they are effective. We do not know if they are of good quality. We don't know what they are."

Another concern is that some are not labeled appropriately for use in young children. Many of these ingredients were the subject of a 2008 public health advisory the FDA issued on OTC cough and cold products. That advisory warned that non-prescription products should not be given to children under 2 years of age because of the possibility of serious, life-threatening side effects.

Almost all are made in the U.S., and many of these drugs have been on the market for years, before a 1962 law that required products be proved safe and effective before getting approval. Despite that law, many remained on the market illegally. The Drug Listing Act of 1972 required companies to submit a list their unapproved drugs to the FDA.

In 2006, the agency announced its Unapproved Drugs Initiative, an effort to bring all unapproved drugs into compliance. Manufacturers were asked to submit a list of their unapproved products to the FDA.

Many of them have names unfamiliar to most: cardec, lodran24D, organidin, pedia-hist - all combinations of antihistamines, decongestants or antitussives (cough suppressants). Autor says many doctors are unaware that the drugs are not approved and prescribe them unknowningly.

Dr. Michael Levy, director, division of New Drugs and Labeling Compliance, Office of Compliance, CDER, FDA says a handful of adverse events linked to these products have been reported. They have not been serious, Levy says, mostly sedation, drowsiness and irritability linked to antihistamines and decongestants. He believes these events are underreported, which is why regulators need to act now.

The agency is giving companies making or selling unapproved products 90 days to stop manufacturing and 180 days to stop shipping. Companies that have not listed their unapproved products with the FDA must remove them from the market immediately.


soundoff (41 Responses)
  1. Joe

    I don't even feel like CNN deserves me to read this most of the time I don't or can't stomach the garbage in these articals..the FDA targets anything that might have the potential of curing something and anybody who can't grease their palms with cash..they are quite simply just as corrupt as the FCC and the FTC.

    March 2, 2011 at 16:16 | Report abuse | Reply
    • Rob

      I am sure the FDA has saved you more times than you even know. If they didnt do what they did the entire population would be at risk. You probably dont realize that it was the FDA that kept Thalidomide off the market in the US and it ended up causing thousands of birth defects around the world. The FDA doest want to take them away, they just want to make sure they are safe and effective. If the companies prove this, no issue.

      March 2, 2011 at 23:48 | Report abuse |
    • Carl

      Rob, the FDA has to look like they are doing something good to maintain status quo. The truth is the FDA is indirectly killing Americans and has so for many years. Properly prescribed medication kills 100,000 Americans every year. That's really protecting us. They rely on drug companies' trials as their only source of efficacy and safety. Let me say that again: THEY LET THE PRODUCT MAKERS TELL THEM THEIR PRODUCT IS SAFE OR NOT. Given the amount of people Vioxx killed and the girls dying and getting maimed from Gardisil, I would say they are doing a bang up job. Let's cut the crap, the FDA is in bed with Big Pharma. The people at the top of the FDA are always former Big Pharma board members, it's such a joke. Here's a good way to follow: If the FDA says something is bad for you, it usually means it's good for you. If they say something is safe and effective, run for the hills.

      March 3, 2011 at 00:39 | Report abuse |
    • Tom Monter

      Rob I suggest you look at several other drugs before you crow about thalidomide which just happened to be luck. You should look at how the FDA has become a stick to beat down generics people need to live and then granting patents for drugs that have been on the market for 200+ years and used safely. Do some research into generic Colchacine and how the FDA is colluding with a company to drive up the price.

      By the way Thalidomide is no longer banned, it's uses are just limited.

      March 3, 2011 at 02:09 | Report abuse |
  2. CLS88

    Colds and flu are a choice you take.

    If you don't want them maintain your circulating vitamin D i nthe range of 50-80 ng/ml, year round and for life.

    Why do you think nobody catches colds or flu in summer?

    Vitamin D levels peak at this time.

    Getting sick from cold or flu infections is a choice.

    You can be miserable and suffer or take your vitamin D.

    March 2, 2011 at 16:32 | Report abuse | Reply
    • Mamudoon

      Huh, I take huge amounts of Vitamin D daily (I have to take over the "recommended" amount due to chronic pain, which it can help, and malabsorption issues from my colitis) and still wound up with a cold this season. Care to offer an explanation?

      March 2, 2011 at 16:55 | Report abuse |
    • Good Patient

      CLS, you're full of it. Vitamin D is no miracle drug and taking it will not prevent colds or flu.

      March 2, 2011 at 17:03 | Report abuse |
    • KritterKat

      People do get colds in the summer. And the flu virus is more virulent in cold, dark seasons.

      March 2, 2011 at 17:04 | Report abuse |
    • Good Patient

      Colds and flu peak during the winter months because people are staying inside with windows closed. It is far easier to come into contact with a rhinovirus than it is during the summer. In addition, the air is drier and dries out the mucus membranes, making it easier for rhinoviruses to survive.

      I take vitamin D supplements and I have a freakin' cold RIGHT NOW because I was exposed to someone else who had one that I was not immune to. Bonehead.

      March 2, 2011 at 17:06 | Report abuse |
    • Good Patient

      Are you daft, Muma? This poster is here 24/7 shilling for some manufacturer that sells vitamin D supplements. He goes by various screen names, and when asked to prove his claims that vitamin can cure/prevent everything from the common cold to cancer will ridicule anyone who questions his "research" and will fail to provide any proof whatsoever of his claims. He brags about how he's "studied and studied", but won't tell anyone what his qualifications are, except to say he "went to college." He's a fake, a phony, a charlatan.

      March 2, 2011 at 17:31 | Report abuse |
    • mrblue

      @CLS88
      I do not believe you. I do not trust you. What you wrote does not even read as plausible.

      March 2, 2011 at 21:30 | Report abuse |
    • Evelyn

      There is more to preventing colds and flu than Vitamin D; certainly, it does help to get sunshine regularly, but boosting the immune system is really the key. There are several good immune-boosting remedies out there; just read the labels and research any ingredient you're not familiar with. That's the beauty of "alternative" medicine; the availability of which inspire us to educate ourselves, instead of relying on the allopathic system. And, in case anyone is interested, I have a Master's degree in Natural Health and consult clients about health and wellness.

      March 2, 2011 at 21:50 | Report abuse |
    • tom, Tom, the Piper's Son

      Oh, get a grip, CL. You're no better than a snake-oil salesman. Vitamin D is no more a cure-all than is Echinacea, or Zinc, or any other substance people like you have touted over the years.

      Stop lying.

      March 2, 2011 at 22:17 | Report abuse |
    • Me

      The only colds I ever catch are in the summer, from using the AC too much.

      March 2, 2011 at 23:48 | Report abuse |
  3. Klatu Berata Nicto

    Why don't they "take aim" at those prescription drugs advertised on tv that have side effects worse than what they're treating. You know, the ones that are followed up by lawyer commercials saying "have you or someone you loved died from complications from "x" drug, then contact us"....I mean, what the heck is the FDA doing? Certainly not their job.

    March 2, 2011 at 16:52 | Report abuse | Reply
    • Mamudoon

      They have. These "lawsuit" medications are almost always required to have a black box warning on them informing doctors and patients of the risk of potentially serious side effects. And for the record, anything you put in your body can cause you harm, no matter if it's chemical, natural, or common.

      March 2, 2011 at 16:57 | Report abuse |
    • Pumbaa

      The government should stop the advertising of prescription drugs on television. If the drugs are so dangerous they need a prescription then lay consumers should not be asking their doctors to order them.

      If the FDA ever requires safety studies of aspirin it will probably get banned from the market.

      March 2, 2011 at 20:03 | Report abuse |
    • Rob

      I swear people. Understand the laws and regulations before commenting. The companies have to not EVERY SINGLE POTENTIAL SIDE EFFECT, even those that were LIKELY CAUSED BY SOMETHING ELSE. These studies have thousands of patients. Just due to the sheer numbers there will be apparent side effects. They do this to warn consumers of all the risks, just like your doctor should (but probably doesnt). No drug is 100% safe but they provide huge value to those who it does help. Nothing would ever be able to be used if it had to have no side effects for approval.

      And those Lawyers are just ambulance chasers. How many old people do you know who have died? I bet many of them were old and on these precriptions but they most likely didnt kill them. These lawyer commercials are a joke.

      March 2, 2011 at 23:56 | Report abuse |
  4. KritterKat

    Cold medicine has never helped me one bit. I stopped believing in it years ago.

    March 2, 2011 at 17:02 | Report abuse | Reply
  5. tejas

    i take calcium 600 and vit D 3 – 400 IU TWICE DAILY regularly but still got the flu (severe) for 2 days - could you explain CLS 88 why am i still getting it

    March 2, 2011 at 18:22 | Report abuse | Reply
    • Good Patient

      Good luck getting any "explanation" from that phony.

      March 2, 2011 at 19:15 | Report abuse |
    • Evelyn

      Because those supplements alone aren't enough, in your case, to increase your immune system to a level that would help you fight off cold or flu germs. See my comment CLS88, above.

      March 2, 2011 at 21:53 | Report abuse |
    • tom, Tom, the Piper's Son

      No supplement is sufficient to prevent every cold or flu. Not a single one or any combination of them in some magic formula. The only people who never get sick are those who never come in contact with anyone else.

      Stop expecting miracles.

      March 2, 2011 at 22:15 | Report abuse |
  6. Frank

    Humans and all animals managed to make it without pills for billions of years. Our surrounding is filled with what our body needs: we're here because of it. There's nothing like raspberries, blueberries, strawberries, grains...especially when I get sick. I never take pills.

    March 2, 2011 at 20:28 | Report abuse | Reply
    • Good Patient

      Umm, sure. I guess vaccines, antibiotics and the like are just unnecessary, right? After all, the Neanderthals had the same berries we do-too bad they only lived for what, a couple of decades at best?

      Please. Modern medicine is a marvel and we're lucky to have it.

      March 2, 2011 at 22:12 | Report abuse |
    • Evelyn

      I had to laugh at the moniker, "Good Patient." That's exactly what the medical establishment loves! People who do what they're told without question. Yes, vaccines are necessary for some, not all. I haven't taken an antibiotic in almost 20 years and I've never gotten a flu shot. Surprise! I get sick about every 2 years, and it never lasts for more than a couple of days. I make my own healthcare decisions, and I urge everyone to do the same.

      March 2, 2011 at 22:26 | Report abuse |
  7. pharmD

    First, of all, doctors don't know what is out there or if it works in terms of OTC meds. They still dry to dry up colds with zyrtec or claritin, when these medications don't have anticholinergic properties (ie benadryl, chlorpheniramine)... They recommend otcs for coughs (which pretty much coat the throat with a less than effective "cough suppressant". They recommend zinc OTC for the common cold which keeps you cold from going past the 7-10 day period (the average time period of the common cold).... Yes, some of these medications work (ie mucinex, sudafed, Tylenol, Motrin), but most of the crap OTC is a waste of money and doesn't help a thing. And the funny part is, if the OTC stuff doesn't work, we run to the doctor, who prescribes us an antibiotic (for bacteria) instead of getting a throat culture and diagnosing a virus. My opinion: Wait out those colds and drink fluids and chicken noodle soup (home-made if possible) and your immune system will naturally take care of you.. But hey, its your money... Oh yea, and the FDA sucks because it doesn't have enough funding or people....(why are there so many crap supplements over the counter that don't do a thing...because the FDA can't regulate them)...

    March 2, 2011 at 20:43 | Report abuse | Reply
  8. Boater39

    I'm waiting for them to do the same thing with another useless snake oil fad: echinacea

    March 2, 2011 at 22:05 | Report abuse | Reply
    • Evelyn

      Do you know what it's for? Where and how it's harvested? How the body uses it?

      March 2, 2011 at 22:28 | Report abuse |
    • Bussiebee

      Echinacea? But Why? Why would you wish they would take something away from us that's been successfully used since mankind? Echinacea is a plant that grows like most all foods and vegetables. Why not take away the man made products that kill our young? Like aspartame, Sucralose, Saccharin, Neotame, MSG......

      March 3, 2011 at 07:52 | Report abuse |
  9. Lovely

    These drugs are dangerous, so you have 90 days to stop making them and 6 months to sell what you got. That makes pefect sense now doesn't it.

    March 2, 2011 at 22:15 | Report abuse | Reply
  10. Cert.PharmTech

    The reason that the side effects of these medicines are so horrible is because we are introducing something foreign into the body that would not occur naturally, or disrupts the body's natural course of treatment for itself.

    March 2, 2011 at 22:16 | Report abuse | Reply
    • tom, Tom, the Piper's Son

      There are lots of drugs about which the same thing might be said; that doesn't make THEM dangerous. Antibiotics could fit your description. Are you advocating we just stop taking those, too?

      March 2, 2011 at 22:19 | Report abuse |
  11. Evelyn

    Tom – YES! Anything that doesn't occur in nature we should not ingest.

    March 2, 2011 at 22:28 | Report abuse | Reply
  12. I'm Your Dad

    Here is a novel idea. If you want to fight a cold and flu, wash your hands with soap and water. Good Luck!

    March 2, 2011 at 22:52 | Report abuse | Reply
  13. highway234

    I smear poop in my nose to keep the mucus membranes moist.

    March 2, 2011 at 23:23 | Report abuse | Reply
  14. Terry

    Get an illegal to buy this stuff for you in Mexico. You can hire your own "Over the Counter Drug Mule". The headline will read, "Mule shot while carrying twenty pounds of Vitamin D".

    March 2, 2011 at 23:53 | Report abuse | Reply
  15. Bob The Builder

    I usually just cut my middle leg off when I get the flu. Then I grow a new one.

    March 3, 2011 at 00:10 | Report abuse | Reply
  16. jamie dixion

    this is all about drugs. the drugs problems . i am so sick of hearing about drug problems , the fda can stick it. i going to stock up on it . so there you go FDda all the cough syrup my house can hold

    March 3, 2011 at 01:41 | Report abuse | Reply
  17. Chris

    How about a list of the affected products?

    March 3, 2011 at 03:55 | Report abuse | Reply
  18. Hugo Lansden

    Antihistamines work well to relieve symptoms of different types of allergies, including seasonal (hay fever), indoor, and food allergies, but they can't relieve every symptom. To treat nasal congestion, your doctor may recommend taking a decongestant. Some drugs combine an antihistamine and decongestant.."':

    Good day
    <http://homelifestylejournal.com

    June 7, 2013 at 20:31 | Report abuse | Reply

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