March 09, 2007

Cold Meds Vs. Antipsychotics: The FDA At Work

Stephany at soulful sepulcher has an outstanding post up today ask why the FDA is in rush to assess safety of cold meds in kids but not antipsychotics:

"'We have no data on these agents of what's a safe and effective dose in children,' he [FDA official] told The Times in an interview."

NOW I ask the FDA to question why adult psychiatric medications are used in children; and why this statement regarding OTC cold medications does not apply to psychiatric medications that carry black box warnings:

'We have no data on these agents of what's a safe and effective dose in children', said Ganley when talking about OTC cold remedies.

The FDA has some serious ethical issues in my opinion, the FDA is responsible, and to be held accountable; for any harm done to a child under age 18 taking psychiatric medications.

The FDA is at the top of the pyramid, in my opinion, that needs to be scrutinized; then pharmaceutical companies;then the PCP's that prescribe;then the psychiatrist's; and nurse practioners, and so on.
"

No shit. I'm sure the FDA's response would be for me to put in a FOIA request.

Posted by Philip Dawdy at March 9, 2007 07:22 PM
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Comments

I agree with Stephany about the FDA needing some serious scrutiny. I have my own reasons for FDA-induced anger, and continue to vocalize to legislators that oversight of this once-respected agency is way past due. When I read that one pharmaceutical or another has received a "slap on the wrist" for an egregious wrongdoing, I immediately think that the FDA, too, has been the recipient of only mild and infrequent "slaps on the wrist" from Congress.

There are other culprits, too: the pharmaceutical companies, the reps who pimp themselves for these companies, the healthcare professionals who turn a blind eye on inappropriate or dangerous recommendations/prescribing patterns; the pharmacists whose scripted "do you have questions" at the time he hands an rX over to a patient; the DTC advertising that seeks to make EVERYONE a patient, in need of multiple drugs; and (unfortunately) the patients who have become sheeple--expecting others to provide them with good health, never questioning--blindly trusting in "experts." But I still maintain the emphasis should be rearranged. Not a single rX can get into a patient's body until a supposedly-learned doctor writes the prescription. Of course, when doctors have accepted that they are "the chosen," "the entitled," and have the godfather-like protection of the (mostly-hidden) powerful AMA--don't expect them to ever step-forward and admit the harm they cause with their heuristic, cavalier prescribing patterns.

Posted by: Melody at March 10, 2007 04:47 AM

Not only should the FDA be assessing the safety of adult anti-psychotic and anti-depressant medications for children, but the safety of these in conjunction with other medications commonly prescribed, with particular regard to the possibility of negative interactions that may lead to the misperception of a deterioration or metamorphosis of a child's alleged "psychiatric condition".

At 15, I was prescribed Aurorix and OTC Codral cold & flu tablets at the same time. The pseudoephedrine in Codral, which can wire you under any circumstances, was psychological dynamite when combined with an MAOI. Having never experienced anything remotely resembling psychosis, I became convinced that anthropologists had it wrong; that intelligent humankind had been around for at least a couple of hundred million years and the civilisation had repeatedly annihilated itself with nuclear weapons during this time. This information was conveyed to me from from depths of time and the centre of the earth through a grille in my bedroom floor, which I suppose was a psychotic metaphor for an archaeological dig, where the further underground you go, the older everything is. Scary stuff!

Even at 15 I had to do my own homework to figure out how and why this had happened - there were no contra-indications or the like which would have shed some light on what was happening to me.

Posted by: Ruth at March 10, 2007 05:15 AM

Well you can't make crystal meth out of Effexor. :)

Posted by: zipzip at March 10, 2007 06:59 AM

Thanks for the link. In my opinion, the FDA has lost credibility. If medication approval begins there; then psychiatric medication use in children would have been made illegal. Without evidence of long-term effects in children, the FDA is a reckless entity placing children's lives in danger every single day that doctors are allowed to prescribe adult medications for kids.

Posted by: Stephany at March 10, 2007 08:38 AM

It might be interesting to note; that my daughter also had severe reactions using dextromethorphan (Delsym) cough syrup. As a teenager that stuff wired her. There is a database that shows this common ingredient in cold/cough medicines can be similar to using ecstasy. Imagine Zyprexa and Delsym used together.

Posted by: Stephany at March 10, 2007 08:58 AM

I LOVE the UW Honors Program so much! I'm getting so much indiviualized attention from all these world-class scholars. One Honors proffessor who teaches psychology, took me under his wing, and is helping me do all this psyshology-based research. And then another Honors person, is always asking me to come by her office, just to talk. It's so great! The thing about the UW, is it is SO freakin huge, and I feel like just a number with no one giving a hoot about me. But then I step into Honors and everyone loves me, and I'm like, this is awesome!

Posted by: Gwen at March 10, 2007 12:52 PM

It's not just cold meds, or the FDA - consider the media outcry last week over the 2 and 5 year olds smoking pot:
http://www.cnn.com/2007/US/03/04/pot.kids/index.html

Where is cnn for 2 year olds on atypical antipsychotics?

Posted by: Glenda at March 10, 2007 10:58 PM

Addressing where is CNN re: antipsychotic use in children; or adults having medical problems as a result of using them--I believe it will pick up some media attention once "off-label" use victims speak up more about Seroquel use for instance; and insomnia; along with the diabetes alerts. Currently the average population does not see anything on television except ads FOR meds or ads for "Zyprexa Diabetes" lawsuits.
Once people become aware of this class of medication, and that it is in fact an antipsychotic medication(s)for schizophrenia:

I think we will then see more public outrage. I seriously feel anyone interested in this topic hitting media; make a phone call. (directly to the news station).

Posted by: Stephany at March 11, 2007 11:32 AM

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