As an outgrowth of the controversy over antidepressants and links to suicide, a flap has emerged over the Medication Guide that drugmakers are required to have distributed with their pills. The guide issued in 2005, shortly after the FDA first required Black Box warnings on the pills, was filled with
tips and suggestions for parents and guardians - behavior that can be interpret as worrisome, a reference to clinical study results and specific info on when a doctor visit is a good idea. And the words 'child' and 'children' are mentioned a total of 31 times. (
take a look).
Now, though, a revised version is circulating and, while similar to the 2005 guide, the language is different. The new two-page guide offers a more generalized alert for children, teenagers and young adults - the populations for which Black Box warnings were issued. Some of the specifics found in the earlier guide are missing or condensed, and the emphasis that was initially placed on children is no longer there. And the changes have upset Mike Ferguson, a Republican congressman from New Jersey, who was involved in efforts to ensure the guides were distributed. (This is the new guide).
"I'm disappointed," he tells Pharmalot. "These were directed especially at parents, who should have as much information as possible before they give their children powerful medications. These changes dilute the message. I can appreciate the desire to communicate to a broader population, but they should have created specially marked sections. This is a step backwards. And perhaps we need to have another hearing on the topic."
In an e-mail, an FDA spokeswoman wrote that there were concerns that "the original medication guide was too long and...might actually discourage appropriate prescribing and use of the medications...While the original version focused more on kids under 18, the new data showed us that suicidality signals extended into young adults ages 18 to 24. The way the newer medication guide was written reflects a need to broaden the focus into all audiences. The content was restructured, but actually the advice to clinicians, patients, parents and caregivers is the same."
One parent, who has been embroiled in the antidepressant controversy, is also upset. "The original guide reflected more scientific info and language that clearly was aimed at getting a parent's attention," says Lisa Van Syckel, a New Jersey resident and self-styled activist. "This is watered down and so doesn't serve as the kind of attention grabber that the other guide did. The FDA ought to pay more attention to what parents say."
For her part, the FDA spokesman adds that outside groups, such as the American Psychiatric Association or PhRMA, "did not have any role in the development of these guides." [UPDATE: At hearings last June, the APA testified that the earlier Med Guides may scare docs and patients away from using the drugs].
What do you think? This is the old Med Guide. And this is the new Med Guide. Look, compare and, then, please vote.
Which Med Guide should be distributed?
- Old Med Guide (96%, 265 Votes)
- New Med Guide (4%, 10 Votes)
Total Voters: 275
34 Comments
The old med guide (and not the new guide) refers to section 3. Is it part of a much larger guide? And if so, was this larger section removed for the new guide?
While testifying at the FDA Medguide Hearings in June, I pointed out that there were NO MEDGUIDES at all for Zyprexa or the other atypical antipsychotics. None. Nada. This for a drug that has been on the market since 1996. And in the watered down category, the first warning successfully placed, the same as had been placed by Japan and the EU two years earlier, warned for "Diabetes, hyperglycemia, and death." Since then, hyperglycemia and death have disappeared from the warning. I hope we can find a Congressional champion to help us out. Given this disturbing evidence, the warnings and Medguides should probably all be checked for "watered-down syndrome."
Ed, If you look back at press releases from APA,AAP and countless others during the FDA and Congressional hearings,these groups took great pride in reporting that they helped FDA draft the language.
You can also read the their FDA Testimony of Dec.2006
Check out www.parentsmedguide.org
Hi Jack,
No, actually, the reference in the old guide to Section 3 is describing the next item, or #3, directly below, where there is a list of a dozen or so bullet points. And I would recommend comparing the lists in each. They appear similar, but a word here or there may make a difference to some, understandably so.
Thanks for writing in.
ed at Pharmalot
Thanks Ed. Then I vote for the older guide, because I like how it listed the rate of suicide for placebo and active treatment. Nevertheless, I suspect many of the changes made were made to simplify the language.
Lisa has an interesting point. Though the piece she attached showed the APA and others proudly claiming that they had helped with the original Medguides for antidepressants and ADHD, it was also clearly stated that Pharma made NO contribution at all. So I guess the former groups were busy changing the previous Medguides to their new, diluted form.
Wonder why none of these groups have been "helping" the FDA make Medguides for that most lethal of drugs, Zyprexa, or the other atypicals in its class.
Ellen,
If I recall correctly you attended the FDA Hearing in December 2006.
These individuals advocated for the Psychiatic Goop that has been included in the revised Med Guide.
Parents just want the facts!!!!
How about a dose of reality about medical communications.
1)
Unless I'm missing it somewhere, I don't see a key indicator for suicidality in either set of guidelines - a sudden and unexpected calm in someone who had been agitated or depressed. This is not uncommon in teens and young adults after a decision to end it has been made.
What are we "Hiding" again with this NEW ploy?
Ed,
Would you please post the Dear Healthcare Provider letters from Wyeth and GSK.Its about time that the "PUBLIC" gets to see what the Physicians see.
And then the question to APA and AACAP would be.... Why do you choose not to share this information with patients?......HMMMMM
I know this young man who is ADHA and dyslexic and has never received medication in his life. His parents made sure he had a more rigorous exercise program, because ADHD patients do have moe energy than most, firmer discipline (which the government has managed to remove most parents rights to lean towards the stronger discipline), and would give him a coke to drink to calm him down. He is a 2nd Leiutenant in the Marines and is 23 years old. Parents need to stop trying to take the easy way out with a pill and fight to have our parental rights to discipline restored. Tough love did me just fine as it has alot of other adults.
Without a doubt, I vote for the old guide. This gives parents a clearer picture!
If the aim is to sell more drugs, the new guide is certainly the better of the two. Parents in the new guide are not being informed as well to the actual harm these drugs cause.
Hank, I'm not sure what you're saying. The suicidality link was determined by evaluating the Columbia study of the clinical trial data. This is not related to depression alone. This signal was across the diagnosis spectrum. This is my problem with the current medication guide. It's a primer for suicide due to depression, not suicide as a drug reaction for any diagnosis it is prescribed for. It's not the FDA's job to explain a disease(which this guide has become), it's their job to report adverse, potentially fatal, drug reactions. The suicidal adverse reaction has been seen in those with anxiety, school phobia, migraines etc..... This isn't about depression, this is about the ssri.
One more thing...the new medication guide gives false reassurance to the patient who is given an ssri for a diagnosis other than depression. I hear it all the time. "Oh, that doesn't apply to me because I'm not depressed". When in fact it applies to all who take the drug, regardless of reason.
I think that too many people are over looking the basic knowledge that antidepressants DON'T fix your depression, they numb you so that you can't feel any emotion at all. Not only that but why is it even thought of as a solution when its side affects are suicidal tendencies and DEATH? Honestly I think I'd rather be alive and depressed then dead and DEAD. It seems that people are becoming lazy, and are deciding they would rather pop another pill than look at the REASON they are unhappy. For some people it's just that they aren't doing the right job! They should be a dancer, but they are being a secretary instead shuffling around papers. Thats pretty depressing! Or maybe some "friend" or family member loves to give you "compliments" that stick in you, thats also depressing!
So thats what I have to say, popping a pill is the easy road, but taking the easy road never got anyone anywhere.
On that note, how about not shoving antidepressants down our loved ones throats in the first place?
Melody B.
I agree with you 100% on all your point's, tough love, discipline, exercise all work...but when parental right's are taken away...heck have'nt they just made it easier to let medication do what you think you can't, or what your told you can't as a parent..I know of 5 people personally who have been prescribed antidepressant's, one of them is no longer with us, I have 3 children 15, 18, 20..trying does'nt describe what everyday life is with them, but I knew that going in....and it would be over my dead body that any of them ever take anything...and they too know what I'm talking about...great new's on the Marine and best wish's to him........
I’ve said this before: nothing currently labeled as “mental illness†is actual, medical illness. Mental “disorders†are not truly disorders/diseases; they are psychological (in the mind/behavioral) disturbances. None of them have been scientifically demonstrated to be real diseases of the brain or central nervous system.
Even if a real neurological disorder were discovered to cause emotional/psychological disturbances, that new disorder would be a new neurological disorder, NOT MENTAL ILLNESS! As such it would not be treated by psychiatry it would be treated by neurology.
Medical treatment for any “mental illness†is not possible, as “mental illnesses†are not real medical entities. Taking a drug to alter your own behavior or thought patterns is the same action regardless of whether you have a prescription or are taking street drugs; if there is no disease, there can be no treatment (in a literal, medical sense). Giving a psychoactive drug to a child for a disease which does not exist is poisoning!
These drugs are unnecessary, unjustifiable and harmful. The above facts should be made public and admitted by all. Parents should NEVER give these drugs to their children! I support anything which discourages their use.
Hi Lisa, yes I was there on that very emotional day. It was before I knew there was no Medguide for Zyprexa which I didn't know until I went to prepare for the Medguide meeting in June 2007. I want to thank you for getting your Congressman involved in this and think that will help the cause. About my Congressman....well, that's why I'm working to get someone else in. And why I wrote my Senator (Mikulski, HELP Committee) about this whole broad problem today. Check out the Medguides sometime. Their quality ranges from A to F and heaven knows how often they get changed.
The atypical information is critical because the FDA is now approving them officially for adolescents. Here we go again. SSRI advocates are doing a terrific job. Zyprexa advocates have so far not been as successful, though we do have a few victories notched up. More truth has finally gone on the warning label, and sales are down.
Matthew,
Could be something as small as an allergy to something your in contact with or ingesting every day...your right...test's out the Wazool...all an excuse for drug's and money making.........
Has anyone seen Bob lately??? AH NEVERMIND......
Crackpot, I mean Donna-
Miss me? Sorry that my sole purpose in life isn't hanging on a Pharma board bashing drug companies.
The Old Guide appears to provide more straightforward consumer info. The more facts and less sales pitching, the better.
Bob,
spending 15 min. on here hardly qualify's as hanging...and yes i miss you....like a root canal...have a nice day!
The FDA should just borrow Canada's warning on SSRIs.... to all ages... may cause... SELF HARM OR HARM TO OTHERS !!
These drugs not only cause SUICIDE... they can cause you to MURDER people !!
HEY LADIES AND GENTS- STOP ATTACKING EACH OTHER THAT'S THE WRONG TARGET!
OBVIOUSLY IF THE SELLER AND PROMOTERS ( PHARMA) OF A DRUG/S THAT HAS EXTREME CONTROVERSEY OVER AND OVER FOR THE LAST 10 YEARS, NOT TO MENTION LAWS SUITS COMING OUT THEIR EARS. HAVING BEEN FORCED TO PUT BLACK BOX WARNINGS ON THEIR DRUGS AND LOOSING MILLIONS WITH THEIR SHAREHOLDERS, OF COURSE THEY ARE GOING TO TRY TO SOFTEN THE DANGERS WITHOUT BEING NOTICED! HAH!
THIS IS THE TIP OF THE ICEBERG KIDS !
IF THESE DRUGS CONTINUE TO BE DOLLED OUT THE WAY THEY ARE YOU WILL BE HEARING MORE!
PSYCHIATRIC DRUGS ARE ADDICTING AND DO NOT CURE ANYTHING AND ONLY NUMB THE PERSON AND PROLONG THEIR MISERY WITH THE ONE THING THEY SHOULD BE CONFRONTING WHICH IS THE THING THAT UPSET THEM IN THE FIRST PLACE. ANY "MENTAL DISEASE" IS A HOAX - THERE IS NOT BIOLOGICAL TEST - FACTS TO BACK UP ANY "MENTAL DISEASE".
I liked that the old guide plainly says there are benefits and risks to the medications, and that is part of a list of the four important things to know, written in bold. The new one says remember to never stop taking medication with out doctors' approval in bold, at the top of its list, and does not clearly say there are benefits and risks to the medications.
...I meant to say without at first talking to your doctor
Why shouldn't the pharms be made to publish the nondiluted drug guide and made to distribute it to all schools in Spanish and English versions so that children can bring literature home for their parents to read as well part of an awareness or better yet have all parents as well as the media educators go on CCHR.ORG web site to get updated info and stats ..
The more info. the better so I say the old Guide..
Arthur,
Here in NJ we have two parental informed consent bills Check out Pharmaolts post on In NJ a Fight over the Black Box.
Hopefully we can have the Med Guide in spanish, to my knoweledge one doesnt presently exist.
I vote for the old guide.
Parents NEED to have a good dose of skepticism and trepidation when giving such powerful drugs to children, if at all.