drug agency regulatory warnings

7/30/2019 Drug Agency Regulatory Warnings

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Drug Agency Regulatory Warnings: There have been 31 drug regulatory agency warnings

issued from eight countries on ADHD drugs causing:

Aggression

Agitation

Anxiety

Convulsions

Depression Disturbed sleep

Drug addiction/abuse

Hallucinations

Heart attack

Heart problems

Hostility

Mania/psychosis

Seizures

Stroke

Sudden death

Suicidal ideation/behavior

Violence Weight changes

Drug Studies: There have been 20 studies published from four countries on ADHD drugs

causing:

Abnormal heart rate/rhythm

Birth defects

Blood pressure changes

Delinquency risk

Depression

Drug abuse/addiction

Emotional outbursts

Hallucinations Heart problems

Homicidal ideation

Insomnia

Irritability

Mania/psychosis

Low academic performance

Stunted growth

Sudden death

Suicide risk

Violence

Weight changes

Documented Side Effects of ADHD Drugs:

Aggression/hostility

Agitation

Blood pressure changes

Changes in vision or blurred visionDepression

Dizziness or faintness

Fever


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Hallucinations

Heart attack

HivesHypersensitivity

Impotence

Increased irritability

InsomniaInvoluntary tics/twitching

Irregular heartbeat

Liver problemsLoss of appetite

Mania

Mental/mood changes

Muscle/joint tightness

Nausea

Nervousness

Painful menstruation

Psychosis

RestlessnessSeizures

Sexual dysfunction

Slow/difficult speech

Stomach pain

Stroke

Stunted growthSudden death

Suicidal thoughts

Swelling of face or throat

Tourettes Syndrome

Toxic psychosis

Unusual bleeding/bruisingUnusual sadness/crying

Violent behaviorVomiting

Weight loss

Zombie demeanor

Note: Side effects of psychiatric drugs can persist for months, if not years, after

stopping them. (1)

ADHD Drug Side Effects Reported to the FDA: There have been 14,158 Adverse Drug

Reactions in connection with ADHD drugs/stimulants that have been reported to the FDAsAdverse Event Reporting System (MedWatch), between 2004 and 2011.

The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual

number of side effects occurring are most certainly higher.


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These include:

871 cases of suicidal ideation/behavior (completed suicides and suicide attempts)

636 cases of aggression

593 cases of hallucinations

499 cases of anxiety

495 cases of abnormal behavior

464 cases of depression

220 cases of death/sudden death

147 cases of mania

113 cases of withdrawal symptoms

52 cases of homicidal ideation

44 cases of diabetes

30 cases of hostility

25 cases of coma

23 cases of physical Assault

21 cases of birth defects

13 cases of violence-related symptoms

12 cases of psychosis

11 cases of homicide

9 cases of sexual dysfunction

(2)

ADHD Drug Warnings:

There have been 31 warnings from eight countries (United States, United Kingdom, Canada,

Japan, Australia, New Zealand, France and Singapore) warning that ADHD drugs/stimulants

cause harmful side effects. These include the following (note that some warnings cite more

than one side effect, so the list below may not be equal to the total number of warnings):
http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php?g=1&advanced=false&dn=dc:Stimulant&arg=&arl=&aru=&mf=&advanced=0&search_generic=Stimulant%20(Drug%20Class)&link=true


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12 warnings on stimulants causing heart problems

8 warnings on stimulants causing mania/psychosis

8 warnings on stimulants causing death

3 warnings on stimulants causing hallucinations

2 warnings on stimulants causing depression

2 warnings on stimulants causing violence, hostility or aggression

2 warnings on stimulants causing seizures 1 warning on stimulants causing suicide risk/attempts

1 warning on stimulants causing anxiety

ADHD Drug Studies:

There are 20 studies from four countries (United States, Australia, Denmark and Italy) showing

that ADHD drugs/stimulants cause harmful side effects. These include the following (note that

some studies cite more than one side effect, so the list below may not be equal to the total

number of studies):

5 studies on stimulants causing medication abuse

3 studies on stimulants causing heart problems

2 studies on stimulants causing death 1 study on stimulants causing suicide risk/attempts

1 study on stimulants causing birth defects

1 study on stimulants causing violence

1 study on stimulants causing homicidal ideation

1 study on stimulants causing depression

1 study on stimulants causing mania, psychosis and hallucinations

(1) Psychiatric Drug Side Effects Can Persist After

Stopping Them

Below are studies showing that, even after stopping certain psychiatric drugs, the side effects

may last several months to years afterwards.

Psychotherapy and Psychosomatics Journalpublished a study in October 2012 about

persistent withdrawal effects six months after cessation of taking SSRI antidepressants.

Researchers reviewed self-reporting adverse events between February 2010 andSeptember 2010 and found post-withdrawal symptoms may last several months to

years. Reported symptoms included disturbed mood, emotional liability, irritability, and

poor stress tolerance.

We note in table 1, persistent postwithdrawal disorders, which occur after 6 weeks of drug

withdrawal, rarely disappear spontaneously, and are sufficiently severe and disabling to havepatients returned to previous drug treatment. When their drug treatment is not

restarted,postwithdrawal disorders may last several months to years. Significant

persistent postwithdrawal emergent symptoms noted consist of anxiety disorders, includinggeneralized anxiety and panic attacks, tardive [developing slowly] insomnia, and depressive

disorders including major depression and bipolar illness. Anxiety, disturbed mood, depression,

mood swings, emotional liability, persistent insomnia, irritability, poor stress tolerance, impaired

concentration and impaired memory are the more frequent postwithdrawal symptoms reported

online.


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Dr. John Zajecka reported in the Journal of Clinical Psychiatrythat the agitation and

irritability experienced by patients withdrawing from one SSRI antidepressant could cause

aggressiveness and suicidal impulsivity. The study stated that, Symp toms of[antidepressant] discontinuation have been reported to last as long as 1 month.

(2) The U.S. Drug Enforcement Administration classified the stimulant methylphenidate, also known asRitalin, in the same category as cocaine, morphine and opium.

These graphs show psychiatric drug side effects that have been reported to the FDA. Scroll down to view furthedetails such as STUDIES and WARNINGS for the returned drug(s).


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(3)

drug agency regulatory warnings

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