News and Document archive source
copyrighted material disclaimer at bottom of page

NewsMinecabal-elitecorporatepharmaceutical — Viewing Item


ADD drugs give hallucinations of bugs and snakes { March 22 2006 }

Original Source Link: (May no longer be active)
   http://www.latimes.com/news/nationworld/nation/la-na-fda23mar23,0,966059.story?coll=la-home-headlines

http://www.latimes.com/news/nationworld/nation/la-na-fda23mar23,0,966059.story?coll=la-home-headlines

FDA Calls for Improved Warnings for ADD Drugs
By Ricardo Alonso-Zaldivar
Times Staff Writer

6:24 PM PST, March 22, 2006

WASHINGTON A Food and Drug Administration advisory panel on Wednesday urged beefed up warnings for drugs used to treat attention deficit disorder after hearing about hundreds of cases in which children using the medications experienced frightening hallucinations, often involving bugs and snakes.

The panel, which focuses on pediatric issues, rejected the idea of calling for so-called "black box" warnings -- the strongest label warnings the FDA can impose -- in part because of testimony by psychiatrists and other medical specialists that the drugs fill a critical need for treating mental health problems in children.

The drugs have been under increased scrutiny in recent weeks because another FDA advisory panel, which focuses on drug safety issues, urged the FDA to place black-box warnings on the drugs because of heart risks. Most of the medications are stimulants, which raise blood pressure and have been linked to cases of heart attacks and strokes.

Members of the pediatrics committee said such a drastic warning is not needed for children, since they have a very low overall risk of heart problems. They said children with heart problems should not take the medications.

Medications for attention deficit-hyperactivity disorder include Ritalin, Adderall XR, Concerta, and some generics. It was unclear how the FDA would handle Strattera, which is not a stimulant, but according to some experts appears to have similar effects.

An estimated 4 million to 5 million Americans, mainly children but also increasingly adults, regularly take ADHD medication. U.S. sales of the drugs were recently estimated at $3.6 billion a year. The medications are considered highly effective in reducing symptoms of ADHD, a condition that can lead to frustration and failure at school and work, and for which there is no known cure.

But some prominent physicians have warned that ADHD drugs are being over-prescribed, without regard for patient needs or safety. Cleveland Clinic cardiologist Dr. Steven Nissen is urging the FDA to act "soon and decisively" to restrict the use of ADHD drugs. Nissen was among the first to raise concerns about the heart risks of the painkiller Vioxx, later withdrawn from the market in what widely was seen as a safety debacle for the FDA.

Manufacturers of ADHD drugs told the panel that their data indicate low rates of serious side effects such as heart problems, hallucinations, aggressive behavior or suicidal thoughts -- rates essentially similar to those in the general population.

It remains to be seen how the FDA will handle the conflicting guidance from the two advisory committees. Although both agreed that doctors and patients need more information about the hazards of the medications, the safety committee saw the problem in much more urgent terms.

FDA officials suggested they will try to balance the recommendations. The case is expected to be a test of a new format that the agency is adopting for its prescribing literature, one that will feature a prominent "highlights" section with key drug details. The agency also is considering a special medication guide, written in lay terms for patients and families.

FDA safety officers told the panel their examination of the safety record of attention deficit drugs in children raised clear concerns about hallucinations, and indications of possible problems with aggressive behavior and suicidal thoughts. The agency laid out the evidence on heart risks last month for the safety committee, but officials said more studies are needed to reach a definitive conclusion.

Agency medical experts who pored through reports on hallucinations said they were troubled. "It was striking how often young children described various insects, bugs and worms, both visual and tactile -- which we haven't seen elsewhere," said Dr. Kate Gelperin, one of the FDA reviewers.

Such hallucinations are extremely rare in young children, but they occurred in patients taking commonly prescribed doses. The visions usually went away after they stopped taking the medication.

FDA medical investigators said the pattern of the visions going away when treatment was stopped, and returning when children again started taking medication, convinced them that the hallucinations were drug related. Some manufacturers had advanced an alternate explanation: that the children had underlying psychiatric problems that emerged when their ADHD was brought under control.

Children reported seeing, snakes, spiders, roaches, bugs and jellyfish. In some cases, they felt insects crawling on their skin.



40 percent of americans take prescription drugs
ADD drugs give hallucinations of bugs and snakes { March 22 2006 }
American painkiller use skyrocketing
Anti depresents linked to suicide
Antibiotic causes liver damage
Antidepressant use by adults surges { December 3 2004 }
Antidepressants addictive to some people { August 6 2006 }
Antidepressants remove obsessive focus of love
Antidepressiants increases chance of suicide { December 13 2006 }
Arthritis drugs causing cancer in childen { April 29 2008 }
Bayer sent riskier drug asia latinamerica { May 22 2003 }
Birth defects from paxil in pregnant women { December 8 2005 }
Canada makes drug deals with 2 states against fda wishes { October 5 2004 }
Cholesterol drug causes kidney damage contradicting fda { May 24 2005 }
Cholesterol meds lower test results not improving health { January 15 2008 }
Clinical trials biased by profit funding
Company hid heartattack data for painkiller { December 8 2005 }
Congressman moves retired to drug lobby
Dc council legislation blocks pharmaceutical price gounging { September 21 2005 }
Doctor gives anti depressants to 4 yr old girl
Doctors get kickbacks to promote drugs
Doctors prescribe paxil whenever asked { April 27 2005 }
Drug aleve increases stroke heart attack risk { December 21 2004 }
Drug bill well financed victory
Drug company criminal charges { May 31 2003 }
Drug firms hide studies showing suicidal behavior { September 10 2004 }
Drug firms hype up diseases to boost sales
Drug leader at NIH takes pharmaceutical money { December 22 2004 }
Fda accused too cozy with pharmaceuticals { November 18 2004 }
Fda approval surprises many doctors
Fda prevented drug expert from speaking on anti depressants { April 16 2004 }
Fda wants suicide warning on anti depressants { March 23 2004 }
Fda whistle blower seeks legal help { November 24 2004 }
Fraud studies made by drug company { March 2008 }
Man arrested if not medicating child with drugs { June 7 2004 }
Mccain knocks steroids baseball
Minnesota school shooter using prozac and others { March 26 2005 }
More anti depressant drug warnings by fda
New diabetes pill poses deadly risk
New york state sues paxil company over coverup { June 3 2004 }
Newer antipsychotic drugs more costly less effective { September 20 2005 }
Parents reverse child hyper activity without drugs { December 22 2006 }
Paxil link found with birth defects
Pharmaceutical cholesterol drugs not lowering risk
Pharmaceutical companies court doctors for sells { April 11 2008 }
Pharmaceutical companies using tax exempt charities { June 28 2006 }
Pharmaceutical secrecy on antidepressant data { January 29 2004 }
Pharmaceuticals in tap water through sewage { March 10 2008 }
Pharmaceuticals pay fda more for speedy approvals { November 22 2006 }
Return of vioxx unusual not unprecendented
Rise of european behavior controlling drug
Ritalin could be dangerous to heart { February 10 2006 }
Senators told fda too cozy with drug industry { November 18 2004 }
Sharp rise in ritalin { July 19 2003 }
Sleeping pill causes sleep driving { March 15 2007 }
Sleeping pills once a day increase death rate { March 23 2006 }
Statin drug takers suffer heart attacks anyway
Study criticizes painkiller marketing { January 25 2005 }
Study drugs for students growing { June 11 2006 }
Study shows no good effect from anti depressants { February 25 2008 }
Suicide risk increase with antidepressants { February 18 2005 }
Supreme court allows pharmaceutical to bulldoze homes { June 23 2005 }
Teens increasing pharmaceutical drug abuse { April 21 2005 }
Teens use pharmaceutical drugs to get high { December 21 2006 }
Unapproved drug tested on children in nigeria { May 7 2006 }
Unfavorable drug studies never reported
Viox risk seen with short term use { May 17 2006 }
Women participating in lilly drug trial hangs self { February 9 2004 }

Files Listed: 68



Correction/submissions

CIA FOIA Archive

National Security
Archives
Support one-state solution for Israel and Palestine Tea Party bumper stickers JFK for Dummies, The Assassination made simple