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Wednesday, September 26, 2007
Unapproved prescription drugs ... the backstory
People always ask me, "Where do you find the stories you produce?" And I tell them I find them everywhere -- sometimes in a something I read, sometimes from people I talk to and sometimes I find stories from my own life. This story is one of those times when I turned life experience into a two-part investigation for "360."

A little over seven months ago, in the middle of winter, I gave birth to my second son. Being a second-time mom, I had a little more experience than I did the first time around, so when my newborn got sick with a hacking cough and cold, I called our pediatrician and asked him to prescribe the same cold medicine that I gave my first son as an infant three years ago. Much to my chagrin, my pediatrician told me that the cold medicine that he had formerly prescribed was no longer being given to kids under two. When I asked why? He said it wasn't advised.

Being a journalist and a mom is a unique mix. Not wanting my child to suffer (or for me to have another sleepless night) and a nagging feeling that something wasn't right, I started to do a little research to find out what had changed about the cold medicine. What I found out shocked me -- the drug that I had given my first son as a baby had been pulled off the market because it had not been tested in kids under two and there had been reports of adverse effects in some children. I was completely shocked. I had inadvertently given my first child drugs that could have made him sick.

How could my doctor have prescribed my son something that could have made him sick? Why didn't he know? Why didn't I know? I am in the media. I report the news everyday. I thought there was a system in place to prevent something like this from happening.

Let me preface these questions. Aside from the occasional tantrum and the refusal to kiss some particular relatives, my first son is perfectly fine. But what if he wasn't? How could my doctor not have known that this drug was unapproved? Well, it turns out he and I are not alone in our lack of knowledge. It turns out that 65 million prescriptions are written every year for drugs that are unapproved by the FDA and the FDA has known about it for decades.

This led me to ask more questions -- How does this happen? Who is responsible here? What other drugs are out there that are unapproved? Why don't doctors know which drugs are approved and which aren't?

I mentioned all this to Gary Tuchman, a CNN correspondent and regular on this blog, and my bosses here at "360." Everyone was as curious as I was, so they sent me off in search of answers. The pieces you will see on tonight's program and the text version you can read now on CNN.com are the result of several months of digging and talking to people. The answers we got from the people in charge at the FDA, on Capitol Hill and from a manufacturer might surprise you. They did surprise me.

And for those of you now wondering about my infant son and his cold, well, he got over it with a lot of TLC and vaporizers. It took a lot longer than it did with the cold medicine, and I was a mess, but that's what being a parent is all about. As for my older son, I guess I can blame the tantrums on the cold medicine he got when he was an infant or more realistically, it's probably because he is now three-and-a-half years old.

-- By Audrey Gruber, CNN Producer
Posted By CNN: 1:02 PM ET
  34 Comments
Audrey,
I would have never even known this had you not done this story! I thought all drugs on the market were first gone over and approved by the FDA. Guess we were all wrong!!

So what are they doing, if anything to get these drugs off the market and to prevent it from happening even more?

Looking forward to your and Gary's report!

Cynthia, Covington, Ga.
Posted By Cindy : 1:30 PM ET
I went through the same thing as Audrey. My first child was given an suppository to control vomiting at about 10 months old which worked miraculously on a serious stomach virus. When my third child had the same thing I was told that it isn't recommended for children under 1 yr. of age. I was incredibly annoyed at the lack of understanding of these drugs even from one doctor to another. It's a leap of faith every time you accept a prescrption, even with something you have already used successfully since you don't know what has changed if anything or if individual children react differently. God help us.
Posted By Anonymous : 1:31 PM ET
I am slightly confused by what is ment by unapproved drugs in both the article and blog. do you mean unapproved for for a particular use or unapproved by FDA for use in general? any ledgend or prescription medication has to have FDA approval for one indication prior to being able to be dispense. once approved a doctor may choose to use a medication for conditions or patients not used during the FDA review. There are a few exceptions to this rule as far as FDA approval goes such as commpasionate care for new medications.
Posted By Matt : 1:37 PM ET
these pharmecutical companies are concerned with profit, so it doesn't surprise me their quality control is not very stringent.
Posted By Laura - Tulsa, OK : 1:38 PM ET
Seems as if the higher prescription drug prices climb, the less they care about safety. Thanks for the story.
Posted By Inez, Santa Fe, N.M. : 1:39 PM ET
Hi Audrey, I enjoyed your post. being the mother of 5 (now grown), it sure is scary to think I could have given any one of my children something that hadn't been approved and could have been harmful or worse to them. It would be bad enough if you were prescribed something for yourself, but your child would be so much worse. It kind of makes you wonder, at least over-the-counter medications are all labeled, 'not recommended for chidlren under two'. It's hard to believe a doctor would knowingly do that but I suppose they're too busy to check unless something happened to the child.
This investigation is a good thing and hopefully people will get their doctor to check and see if its been approved yet, especially if its something you're not familiar with.
Posted By Bev Ontario Canada : 1:42 PM ET
Who is responsible? You would think the doctors would be; but when I go to the doctor he pokes and prods then sribbles something in a language only a pharmacist can read. How can the doctors have time to see patients for ten hours and also screen the drugs to know they're approved or not?
Posted By Sam- Dallas, Tx. : 1:43 PM ET
It's startling that we have to worry about our family doctor knowing what he or she is presribing. I think of kindly Marcus Welby,md on the TV show, or the family doctor out of a Norman Rockwell painting; then I think that kind of care is only in our imaginations...
Posted By susan ,detroit, mi : 1:46 PM ET
Im not disputing your report, but there ARE adverse effects people sometimes display to medicine. How do you know that wasn't the case here? Maybe he was allergic.
Posted By greer, boston, mass. : 1:53 PM ET
Hi Audrey, I'm glad to hear your kids are well. I know people who are on medication and I'm now curious if the drugs they're taking are on the "unapproved" list. There should be a law requiring full disclosure of all medications to all doctors and patients and punishment for those who disobey the law. I thought that was already in place with the FDA, but I guess not. Maybe the best way to avoid all this is to stay healthy to begin with so you don't need medication: eat right, exercise, get enough sleep. And oh, watch AC360 every night. :)

I look forward to your reports tonight,

Lilibeth
Edmonds, Washington
Posted By Lilibeth, Edmonds, Washington : 1:56 PM ET
This is something we all should be concerned about. The dr. gave me Vioxx , then they "took it off the market". I went back and he gave me yet another pain drug that was taken off the market a short time later . I figure I won't try a third time - might push my luck!
Posted By Marie P., Burlington, Wi. : 1:56 PM ET
I think we forget that prescription drugs are indeed drugs. They all have side effects that don't injure most people but can nearly kill someone else.
Add to the mix, the endless parade of new wonder drugs rushed to market. Guinea Pigs, that's what we all are...Pills for life saving purposes is one thing, pills for every ache and pain is another.
I think we need to stop the Meds from becoming as easy to pop as candy...The next cold or flu will be TheraFluless for me. Take Care

Lorie Ann, Buellton, Calif.
Posted By Anonymous : 2:04 PM ET
OK no offense but mom didn't get me a prescription unless I was REALLY sick. Every kid got one bad cold over the winter. The upside was that you got to skip school . Now, you open the medicine cabinet and a hundred little bottles come tumbling out. And nowadays, every other commercial is a new drug. When they describe different maladies on these commercials, it's almost as if you sit there and think , 'yea ! I've got that!'
Posted By g. waite, colorado spr., co : 2:05 PM ET
I don't trust these big drug companies to have my best interests at heart. I don't even really trust my doctor, but what can you do?
Posted By Desi, Jerseyville, IL : 2:08 PM ET
I feel safer with over-the-counter medications - at least they are weak strength and I figure if it's unapproved, I won't OD. How is it we live in the supposed best, most highly-developed country" in the world and we have to worry about this stuff?
Posted By Pierce, Littleton, Co. : 2:12 PM ET
Thank you for exposing this sad state of medicine in the US. My son is two, and let me tell you I wish sometimes I could give him something prescription-strength even when he's not sick. No, just kidding.
Posted By nancy bolossa, san mateo, ca. : 2:16 PM ET
People shouldn't have to feel powerless when it comes to their own health and welfare. The FDA is another federal agency that is dropping the ball.
Posted By D.Weller- Spokane, WA. : 2:36 PM ET
I don't think that just because a drug is not approved that it 's unsafe. It could be unsafe, but it also could mean the FDA hasn't gotten around to it yet. It also means the the FDA is not very competent. Come to think, most of what comes out of Washington is not very competent.
Posted By annie, r.n. : 2:45 PM ET
Shouldn't the person in charge of the FDA be more visible and public? We're talking about our childrens' health here. I mean, I wouldn't know how to contact the FDA, and Im sure it wouldn't be quick and easy to do so.
Posted By annette russell, ithaca , ny. : 2:48 PM ET
Hi Audrey,

I think each prescription drug should be inspected before put it out on the market. Now days you don't never know what medicines are shipped from one place to another. Looks like someone is falling down on the job or can just anything be sent to the U.S. without inspection, It sure does look that way.

Thanks for sharing the story, I'm glad that your infant son doing better.

Jennifer - Anderson, South Carolina.
Posted By bluediamond (Jennifer) : 2:55 PM ET
Protecting our family from drugs that could be harmful and Chinese paint and weak bridges across our nation are just some signs that the cracks are beginning to show in our counrty. We need to look out for each other, not just worry about captialism and profit !
Posted By J. P. Tyler Tx. : 3:21 PM ET
Hmmm! Let me guess: the drug companies with their Washington lobby groups. Who cares about those damn consumers!

These are sad times when we can spend 3 billion dollars on war, but yet we can't be sure if the drugs (which mind you are very expensive) are safe or not.
Posted By Anonymous : 3:31 PM ET
here we have another federal agency that has billions flowing in and out but can't protect the boy next door from bad cold medicine
Posted By Jason F., Alexandria, Va. : 3:52 PM ET
Audrey - I got one word for you: TheraFlu !
Posted By Ellie S., Reno, NV. : 3:58 PM ET
What about generic label drugs? If medications made by so-called reputable big-money drug co's are found to be dangerous, who is manufacturing those generic drugs , who is monitoring them, and how safe are generic drugs?
Posted By e. jones, albany, ny. : 4:36 PM ET
As a pharmacist, I am intrigued about this report and very glad to see the public getting involved in their healthcare by questioning medication use. However, I am concerned that this article does not appear to differentiate between un-approved, off-label and grandfathered medications. Many older drugs existed before the FDA, thus were not subjected to the current testing standards.

Nearly all of these medications are time-tested therapies that are life-saving to millions. People should realize that drug (including OTCs) used incorrectly can be deadly. In contrast, many herbal medications and supplements that consumers assume are safe are in fact not subjected to any FDA regulation and not rigorously studied for efficacy and safety.

The FDA has difficult job, but has prevented many dangerous medications from reaching the consumer. I wish more reporting would focus on these frequent interventions to protect patients, rather than sensationalizing these rare cases.
Posted By Dan : 4:40 PM ET
As a pharmacist, I am intrigued about this report and very glad to see the public getting involved in their healthcare by questioning medication use. However, I am concerned that this article does not appear to differentiate between un-approved, off-label and grandfathered medications. Many older drugs existed before the FDA, thus were not subjected to the current testing standards.

Nearly all of these medications are time-tested therapies that are life-saving to millions. People should realize that drug (including OTCs) used incorrectly can be deadly. In contrast, many herbal medications and supplements that consumers assume are safe are in fact not subjected to any FDA regulation and not rigorously studied for efficacy and safety.

The FDA has difficult job, but has prevented many dangerous medications from reaching the consumer. I wish more reporting would focus on these frequent interventions to protect patients, rather than sensationalizing these rare cases.
Posted By Dan : 4:41 PM ET
I am currently a second year pharmacy student and we talk about this subject all the time in various classes. FDA approval is a very complicated issue because people want drugs approved with perfect accuracy as fast as possible. The bottom line is that over the counter drugs can cause an overdose and adverse drug reactions just as frequently as prescription drugs, especially in neonates and children and so it is important to talk to the pharmacist behind the counter. We are there to answer your questions, we will not bite, I promise!
Posted By Dusten North, South Carolina : 5:04 PM ET
Yikes! I thought I was just a chicken! I try to stay away from doctors and medicine unless I am really suffering. There always seems to be a new study concerning a familiar prescription.
Posted By Kathy Chicago,Il : 5:11 PM ET
Audrey/AC360:
How can the US government complain about lead-based painted toys produced in China but be totally oblivious of unapproved American medications being given to our young children?

It is going to be an unusual Christmas and flu season coming up soon. Let's go back to reading books, paper dolls and chicken soup.
Posted By Sharon D., Indianapolis, Indiana : 5:14 PM ET
Hi,
What an interesting and scary story! It makes you wonder what other drugs out there are not really tested well and yet are allowed to be sold to people. Sometimes your medicine can make you more ill!
I'm glad your baby is feeling better.
Posted By Pamina, New Rochelle, NY : 5:24 PM ET
Hi Audrey,
Glad your kids are well. I was really amazed to see that a drug that I was practically raised on, phenobarbital, was mentioned in your report. Though I'm grateful to be here, which might not have been the case without that drug if I'd had a catastrophic seizure, I wonder what undocumented side effects I had to endure as a result of the lack of testing. For years I was also on antihistimines for hay fever, so I looked like a walking zombie and was listening to people remark about "Why don't you just get off the pills?" and "You don't look like you have a problem." Though I want drugs to be approved, some of the posted comments about just stay healthy and don't take so many pills miss the point that, for some of us, taking medication is not a choice but a necessity, so all drugs should be approved. Maybe there should be a limit on the approval process, so drugs could be re-evaluated in the light of new research as well.
Posted By Anonymous : 6:50 AM ET
What the heck is the point of the FDA then????
Posted By Anonymous : 12:41 PM ET
As a physician, I have lost patients because I would not prescribe infants and toddlers prescription cold medications of dubious safety. Parents want a magic cold pill to miraculously cure a child and make them sleep through the night. Chicken soup and rest are safer and just as effective!
Posted By NC MD : 5:09 PM ET
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