Several FDA advisories have been issued in the last several years for the drugs my son takes---NOT ONCE were we informed about the advisories or warnings by a prescribing psychiatrist or dispensing pharmacist.
Several weeks ago I was chatting with a woman online who was telling me about health issues her fourteen-year-old was having: Massive weight gain, cardiac issues requiring an EKG, metabolism issues and needing to be checked for diabetes, high cholesterol, and aggressive behavior. I asked if she had been told that all of these issues are KNOWN effects of the neuroleptic drug her child was taking---although she does not have a diagnosis of Schizophrenia or Bipolar disorder---she was shocked to learn they are known risks for the drugs, and that the drug is not approved for children without a diagnosis of schizophrenia, bipolar or autism. NONE of the risks mentioned above had been disclosed by the psychiatrist prescribing the drug---to the parent or to the child; who at the age of fourteen, under Washington State Law is capable of giving Informed Consent for these dangerous teratogenic drugs. If the prescribers and the FDA are not sharing known risks, is there such a thing as Informed Consent even taking place?
via PLos ONE:
"Violent thoughts and acts towards others area common occurrence in our society but rarely studied as an adverse drug event. Increased risk of suicidal behaviors—but not violence— associated with antidepressants has been examined through meta-analysis of clinical trials for approval by the U.S. Food and Drug Administration. [1], [2]
Despite limited clinical study, numerous drugs contain FDA-required warnings to doctors or patients about the possibility of aggressive or violent acts. Among the drugs with warnings about aggressive behaviors are varenicline, zolpidem, montelukast, and all antidepressant drugs. [3]–[6] The mandatory patient Medication Guide for varenicline, the antidepressants and quetiapine warn patients to contact a healthcare provider immediately if they start “acting aggressive, being angry or violent.” [3], [7]–[9]
In this study we summarize and evaluate the evidence about reported acts of violence associated with therapeutic drugs among all serious adverse drug events reported to the FDA from 2004 through the third quarter of 2009." read the article here.
via SSRI Stories:
65 School Shootings/Incidents Involving SSRIs
Most of the stories on this site describe events that occurred after the year 2000. The increase in online news material and the efficiency of search engines has greatly increased the ability to track stories. Even these 4,700+documented stories only represent the tip of an iceberg since most stories do not make it into the media. There are 115 cases of bizarre behavior, 65 school shootings/incidents, 68 road rage tragedies, 19 air rage incidents, 101 arson cases, 70 postpartum depression cases, over 1,000 murders (homicides) or murder attempts, over 300 murder-suicides (30% committed by women) and other acts of violence including workplace violence on this site. There are also over 100 Journal Articles and FDA reports listed in the Index. They are at the top of the Index immediately below the 65 school shootings/incidents and the 26 "won" criminal cases.
FDA Public Health Advisory
On March 22, 2004 the FDA published a Public Health Advisory that reiterates several of these side effects and states (in part) "Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric." (Click Links button at bottom of this page for a direct link to this FDA Warning.)
On September 14, 2004 the FDA added a Black Box Warning in regard to antidepressants & suicidality in those under age 18.
On September 14, 2004 the FDA mandated that pharmacies provide to all parents or guardians for those younger than 18 an Antidepressant Patient Medication Guide. This guide reads (in part) "Call healthcare provider right away if you or your family member has any of the following symptoms: Acting aggressive, being angry, or violent & acting on dangerous impulses." This Antidepressant Patient Medication Guide also states "Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms." (Click Links button at bottom of this page for a direct link to this FDA Antidepressant Guide.)
On December 13, 2006, the Black Box Warning for suicidality was updated to include those under age 25. The Black Box Warning is included in the insert to the drugs and in the Physicians' Desk reference.
An Absence of Controlled Scientific Evidence
In the Journal of American Physicians and Surgeons, Volume 14, Number 1, Spring 2009, there is a journal article by Joel M. Kauffman, Ph.D., which is titled: Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risk Than Benefits?" In reference to SSRIStories.com, Dr. Kaufmann made the following statement: "Since no clinical trial involving multiple homicides is ever likely to be run, no firmer evidence is likely to be found. Healy noted that much of the evidence for suicide and murder came from the efforts of journalists and lawyers."
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