Zyprexa Reviewed for Children's Use

Zyprexa has come up a lot on this blog lately. It's come up again - an FDA Panel has been formed to review Zyprexa off-label use for children. Apparently Zyprexa is supposed to be prescribed for schizophrenia and bipolar disorder, but is often prescribed for off-label disorders such as dementia and mild bipolar disorder. Another off-label prescription has been for kids. The FDA Panel has been convened to see about adding side effect warnings specifically for kids - as Zyprexa has been known to cause diabetes and other blood-sugar disorders.

Eli-Lilly is apparently pushing the FDA to approve Zyprexa for children between 13-17. With the not-uncommon side effect of diabetes, I wouldn't want my kid on it.

FDA - A Step in the Right Direction

The FDA reports that they will be providing the public with quarterly reports of the drugs that are undergoing safety investigations due to complaints from patients, manufacturers and physicians. This is definitely a step in the right direction and an excellent plan for the FDA. They are opening their doors to consumers more and more, letting us see what is actually happening with a drug and what could possibly happen so we can make better, educated decisions.

Thomas Jefferson Quote about the FDA

Thomas Jefferson comments on the FDA before it existed:



"If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls who live under tyranny" - Thomas Jefferson (1743 - 1826)



Interesting, eh?

New Warnings for Abilify

The FDA has issued changes to the Abilify box warnings. The box now warns of seizures and convulsions, head rushes and possible cognative and motor impairment. I just wanted to send out a little update on this, since the FDA doesn't let you know about this sort of thing unless you sign up for updates - which you can do here.

Army Hero Used for Drug Expirement

Reporting Side Effects Directly to the FDA

There is a 1800# and website to report adverse side effects of drugs to the FDA directly. The FDA currently is offering this information on print ads, but not on tv ads. This articles tells that the Consumers Union is now appealing to the FDA to get this information out in TV ads, along with the print ad campaign. They have compelling statistics - among those who take prescription drugs, one in six experienced a serious side effect. Only thirty-five percent of these people knew that you could report the side effect to the FDA directly. Eighty-one percent had seen or heard a drug ad in the last month, but ninety-one percent had seen this ad on tv. So, by putting this number on television ads, it would reach the majority demographic of prescription drug users.

The 1800# is: 1-800-FDA-1088 and the website to report side effects direct to the FDA is www.fda.gov/medwatch.

FDA Outlook - Bleak or Rosy?

The FDA announced they will be hiring over a thousand new employees over the next year. However, this article accuses them of just playing catch up. Others look at the new hiring as an interesting move by the FDA and are hopeful that all these new employees will help in food and drug oversight, as well as make FDA service faster.

What do you think? With all these new employees, will the FDA change their ways and become an efficient group instead of a glorified DMV for food and drugs?

Great Links About Psychiatry

Here's some great links I found this week:

Scientology Lives reports connections between school shooters and psychiatric drugs

DBunker reports that the FDA is cracking down on neighborhood pharmacies

Alliance for Human Research Project reports about Eli Lilly concealing information

Pharmalot reports that Eli Lilly should have warned the American people about Zyprexa back in 1998

Grahame reports about a new anti-depressant (called Placebozac) that has just come on the market *This one deserves a warning for excessive sarcasm*

Attention Deficit Disorder reports some interesting statistics about ADHD kids

PsychWatch reports 8 reasons to run from Anti-Depressants

Great Links About Psychiatry

Here are some great links to start March out with:

Psychdata reports on the Mothers Act

The Alliance for Human Research Project reports on the Zyprexa saga

The Alliance for Human Research Project reports on Ablify

Attention Deficit Disorder reports on how to use vitamins to curb ADHD and ADD symptoms

Grahame reports that Prozac doesn't work

Psychwatch reports that 80% of suicides in Sweden are committed by people on anti-depressants

MSNBC reports on using psychiatry as punishment in Russia

DBunker reports on drug companies hiding the negative results of clinical trials (please note that DBunker's blog contains uninhibited terms and strong language.)

Scientology Against Drugs asks, is Bipolar Disorder real?

These are all very interesting articles. Check 'em out!

The FDA - A Step in the Right Direction

While it seems that anything the FDA does is based upon an imperfect system, there is a new effort being launched by the FDA to oversee the side-effects of prescription drugs. I believe (but this is unverified) that they might be making a data base of these side-effects available for consumer use, which would be incredibly beneficial.

So, pros:
a) A database with side-effect listed (yay!) so we don't all have to read ten pages of fine print when a drug is prescribed to us.
b) More oversite on prescription drugs so that things like the Zyprexa debacle aren't repeated.

Cons:
a) In usual FDA fashion, the new effort (called "Safety First") might be unwilling to pull a drug they have already approved.
b) They could get in cahoots with various drug manufacturers.

I say that this is a change for the better. The Pros are something new and the Cons are cons that have been around since the FDA's inception. What do you think?

FDA Looks as Clinical Trials

This International Herald Tribune article states that now the FDA is requiring many drugs be looked into to see if they have suicidality as a side-effect. This is really good news! If the FDA becomes more aware of what each drug on the market does, they have to publish that information for us non-government people.