Adderall XR sales were suspended in Canada in 2005 and the FDA issued a label change that made it clear that Adderall XR should not be given to patients with heart defects.
All this occurred after Shire Pharmaceuticals (the manufacturer of Adderall) reported the 12 child deaths to U.S. and Canadian regulatory agencies. The deaths occurred in the U.S. between 1999 and 2003. More than 37 million prescriptions of the drug were written, at the time, for about one million patients worldwide. The sudden deaths occurred in children taking Adderall or Adderall XR.
In 2010, this warning still applies to Adderall and AdderallXR.
This is the Black Box warning that the FDA lists for Adderall and Adderall XR. This is the strongest warning from the FDA due to the drug's serious, or even life-threatening, adverse effects.
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
What is important to remember is that every individual has the right to Informed Consent. For more information contact the Citizens Commission on Human Rights of Florida (CCHR Florida), a non-profit organization that investigates and exposes psychiatric violations of human rights. CCHR was co-founded in 1969 by Professor Thomas Szasz, Professor of Psychiatry Emeritus, and the Church of Scientology, dedicated solely to eradicate mental health abuse. It works side-by-side with like-minded groups and individuals who share a common purpose to clean up the field of mental health. www.cchrflorida.org/informed-consent.
The Informed Consent includes your rights to know about the side effects and the alternatives to psychiatric drugs.
Very often when a person is experiencing emotional or behavioral problems, there is an underlying, undiagnosed medical condition causing the symptoms diagnosed as a psychiatric disorder. These conditions include, but are not limited to, allergies, infections, sleep disorders, toxins, nutritional deficiencies and hormone imbalances.
It is recommended to get a complete physical examination by a competent medical practitioner who does not prescribe psychiatric drugs.
WARNING: No one should stop taking any psychiatric drug without the advice and assistance of a competent, medical doctor who does not prescribe psychiatric drugs!
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