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International Warnings on Psychiatric Drugs 2004 – 2007

November 2, 2007 3 comments

Number of International Studies and Warnings on Psychiatric Drugs, 2002-2006

2004

February 2: FDA official Dr. Andrew D. Mosholder testified before the FDAs Psychopharmacological Advisory Committee on the Office of Drug Safety Data Resources for the Study of Suicidal Events, warning that children being prescribed the newer antidepressants were at risk of suicide.

March 22: The FDA warned that Prozac-like antidepressants (called Selective Serotonin Reuptake Inhibitors or SSRIs) could cause “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement] and mania [psychosis characterized by exalted feelings, delusions of grandeur].”

June: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting that the latest antipsychotics could increase the risk of diabetes.

June: The FDA ordered that the packaging for the stimulant Adderall include a warning about sudden cardiovascular deaths, especially in children with underlying heart disease.

August 20: A Columbia University review of the pediatric (child) clinical trials of Zoloft, Celexa, Effexor, Wellbutrin, Paxil and Prozac, found that young people who took them could experience suicidal thoughts or actions.

September 21: Following a BBC news report on antidepressants causing aggression and homicidal behavior, the British Healthcare Products Regulatory Authority advised that it had issued guidelines that children should not be given most SSRIs because clinical trial data showed an increased rate of harmful outcomes, including hostility.

October 15: The FDA ordered a “black box” warning for antidepressants that they could cause suicidal thoughts and actions in under 18 year olds taking them.

October 21: The New Zealand Medicines Adverse Reactions Committee recommended that old and new antidepressants not be administered to patients less than 18 years of age because of the potential risk of suicide.

December: The Australian Therapeutic Goods Administration children and adolescents prescribed SSRI antidepressants should be carefully monitored for the emergence of suicidal ideation. In a recent study involving Prozac, it said, there was an increase in adverse psychiatric events (acts and ideation [thoughts] of suicide, self-harm, aggression, violence.)

December 9: The European Medicines Agencys Committee for Medicinal Products for Human Use confirmed that product information should be changed for antidepressants to warn of the risk of suicide-related behavior in children and adolescents and of withdrawal reactions on stopping treatment.

December 17: The FDA required that packaging for the “ADHD” drug Straterra carry a new warning advising, “Severe liver damage may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients.”

2005

February 9: Health Canada, the Canadian counterpart of the FDA, suspended marketing of Adderall XR (Extended Release, given once a day) due to reports of 20 sudden unexplained deaths (14 in children) and 12 strokes (2 in children) in patients taking Adderall or Adderall XR.

February 18: A study published in the British Medical Journal determined that adults taking SSRI antidepressants were more than twice as likely to attempt suicide as patients given placebo.

April: The British House of Commons (Parliament) Health Committee issued a damning report that SSRI antidepressants had been “indiscriminately prescribed on a grand scale” and that drug companies have marketed the drugs without punishment to treat “unhappiness [that] is part of the spectrum of human experience, not a medical condition.”

April 11: The FDA warned that antipsychotic drugs in elderly patients could increase the risk of death.

April 21: A national non-government organization, Partnership for a Drug-Free America, released its findings of a study that determined that 10% of teens (2.3 million) had abused the stimulants Ritalin and Adderall.

April 25: The European Medicines Agencys Committee for Medicinal Products for Human Use reaffirmed that all the latest antidepressants could cause increased suicide-related behavior and hostility in young people.

June 28: The FDA announced its intention to make labeling changes to Concerta and other Ritalin products to include the side effects: “visual hallucinations, suicidal ideation [ideas], psychotic behavior, as well as aggression or violent behavior.”

June 30: The FDA warned that the latest antidepressant Cymbalta could increase suicidal thinking or behavior in pediatric patients taking it.

June 30: The FDA also warned about a potential increased risk of suicidal behavior in adults taking antidepressants, broadening its earlier warning that related only to children and adolescents taking the drugs.

July 1: An FDA “Talk Paper” said that it had requested antidepressant manufacturers to provide all information from their clinical trials on possible increased suicidal behavior in adults taking the drugs.

July 7: The National Center on Addiction and Substance Abuse at Columbia University issued a report called “Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S.” that determined 15 million Americans were getting high on painkillers and psychiatric drugs such as the tranquilizer Xanax and the stimulants Ritalin and Adderall. Between 1992 and 2003, the number of 12 to 17 year olds abusing these drugs had risen 212%. Teens who abused prescription drugs were 12 times likelier to use heroin, 15 times likelier to use Ecstasy and 21 times likelier to use cocaine, compared to teens that did not abuse such drugs.

July 16: The British Medical Journal published a study, “Efficacy of antidepressants in adults,” by Joanna Moncrieff, senior lecturer in psychiatry at University College London who found that antidepressants were no more effective than a placebo (fake pill) and do not reduce depression. In a media interview on the study, Dr. Moncrieff stated, “The bottom line is that we really dont have any good evidence that these drugs work.”

August: The Australian Therapeutic Goods Administration found a relationship between antidepressants and suicidality, akathisia (severe restlessness), agitation, nervousness and anxiety in adults. Similar symptoms could occur during withdrawal from the drugs, it determined.

August 19: The European Medicines Agencys Committee for Medicinal Products for Human Use issued its strongest warning against child antidepressant use, stating that the drugs caused suicide attempts and thoughts, aggression, hostility, aggression, oppositional behavior and anger.

August 22: Norwegian researchers found that patients taking antidepressants were seven times more likely to experience suicide than those taking placebo.

September 7: The Australian Therapeutic Goods Administration warned that antidepressant use during pregnancy could cause “withdrawal effects that can be severe or life-threatening.”

September 13: The Oregon Health & Science University, Evidence-Based Practice Center published the findings of its review of 2,287 studiesvirtually every study ever conducted on “ADHD” drugsand found that there were no trials showing the effectiveness of these drugs and that there was a lack of evidence that they could affect “academic performance, risky behaviors, social achievements, etc.” Further, “We found no evidence on long-term safety of drugs used to treat ADHD in young children” or “adolescents.”

September 22: Dr. Jeffrey Lieberman of Columbia University and other researchers published a federally funded study in the New England Journal of Medicine about the effectiveness of certain antipsychotic drugs, comparing an older generation of antipsychotics with several newer ones. Far from proving effectiveness, of the 1,493 patients who had participated, 74% discontinued their antipsychotic drugs before the end of their treatment due to inefficacy, intolerable side effects or other reasons. After 18 months of taking Zyprexa, 64% of the patients taking this stopped, most commonly because it caused sleepiness, weight gain or neurological symptoms like stiffness and tremors.

September 26: The Italian Gazette (official news agency of the Italian government) published a resolution of the Agenzia Italiana del Farmaco (Italian Drug Agency, equivalent to the FDA) ordering a warning label for older (tricyclic) antidepressants that the drugs should not be prescribed for under 18 year olds. They also determined that they were associated with heart attacks in people of any age.

September 27: The FDA warned that Paxil and other antidepressants taken during the first trimester of pregnancy could cause increased risk of major birth defects, including heart malformations in newborn infants.

September 28: The British National Health Services Institute for Health and Clinical Excellence released a Clinical Guideline for treatment of “Depression in Children and Young People.” It advised “all antidepressant drugs have significant risks when given to children and young people” and instead, they should be “offered advice on the benefits of regular exercise,” “sleep hygiene,” “nutrition and the benefits of a balanced diet.”

September 29: The FDA directed Eli Lilly & Co. to revise Strattera labeling to include a boxed warning about the increased risk of suicidal thinking in children and adolescents taking it.

September 29: The UK Medicines and Healthcare Products Regulatory Agency issued a press release that it had begun a review of the risks of Strattera in light of the FDAs direction.

October: The sales and marketing of the stimulant Cylert were stopped in the U.S. because of the risk of liver damage that could lead to death.

October 17: The FDA ordered Eli Lilly & Co. to add a warning to the packaging of its antidepressant Cymbalta, that it could cause liver damage.

October 19: A study in the Journal of the American Medical Association concluded that atypical (newer) antipsychotic drugs could increase the risk of death in elderly people.

October 24: The FDA withdrew Cylert from the market because of its “overall risk of liver toxicity” and liver failure.

November: The FDA approved updated labeling for the antidepressant Effexor XR which noted that this antidepressant can cause homicidal ideation.

December 1: Researchers found that 18% of nearly 23,000 elderly patients taking the older antipsychotics died within the first six months of taking them.

December 8: The FDA warned that Paxil taken by pregnant women in their first trimester may cause birth defects, including heart malformations.

2006

January 5: The FDA said it had received reports of sudden deaths, strokes, heart attacks and hypertension (high blood pressure) in both children and adults taking “ADHD” drugs and asked its Drug Safety and Risk Management advisory committee to examine the potential of cardiovascular (heart) risks of the drugs.

February 4: A University of Texas study published in Pediatric Neurology reported cardiovascular problems in people taking stimulants.

February 5: An analysis of World Health Organization medical records found that infants whose mothers took antidepressants while pregnant could suffer withdrawal effects.

February 6: A study published in the Archives of Pediatrics and Adolescent Medicine determined that nearly one-third of newborn infants whose mothers took SSRI antidepressants during pregnancy experienced withdrawal symptoms that included high-pitched crying, tremors and disturbed sleep.

February 9: The FDAs Drug Safety and Risk Management Advisory Committee urged that the strongest “black box” warning be issued for stimulants, including Ritalin, Adderall and Concerta and that they may cause heart attacks, strokes and sudden death.

February 11: The Australian Therapeutic Goods Administration announced it would review the FDA advisory committee recommendation for stronger warnings against stimulants.

February 20: British authorities warned that the “ADHD” drug Strattera was associated with seizures and potentially lengthening period of the time between heartbeats.

February 25: A study in the journal, Drug and Alcohol Dependence, and reported in The Washington Post revealed that seven million Americans were estimated to have abused stimulant drugs and a substantial amount of teenagers and young adults now appeared to show signs of addiction.

March 10: Health Canada issued a warning that pregnant women taking SSRIs and other newer antidepressants placed newborns at risk of developing a rare lung and heart condition.

March 22-23: Two FDA advisory panels held hearings into the risk of stimulants and another new “ADHD” drug called Sparlon. Between January 2000 and June 30, 2005, the FDA had received almost 1,000 reports of kids experiencing psychosis or mania while taking the drugs. The first panel recommended stronger warnings against stimulants, emphasizing these on special handouts called “Med Guides” that doctors must give to patients with each prescription. The second committee recommended not to approve Sparlon, which the manufacturer, Cephalon, estimated would lose them $100 million in drug sales.

March 28: The Australian Therapeutic Goods Administration announced its review of reports of 400 adverse reactions to stimulants in children taking them. CCHR had filed a Freedom of Information Act request with the TGA to obtain the reports and released this to the media that ran the story internationally.

May 1: An American Journal of Psychiatry study revealed that elderly people prescribed antidepressants such as Prozac, Paxil, and Zoloft are almost five times more likely to commit suicide during the first month on the drugs than those given other classes of antidepressants.

May 3: FDA adverse drug reaction reports linked 45 child deaths to new antipsychotic drugs. There were also more than 1,300 reports of other potentially life-threatening adverse reactions such as convulsions and low white blood cell count.

May 12: GlaxoSmithKline, the manufacturer of Paxil, sent a letter to doctors warning that its antidepressant increases the risk of suicide in adults. It was the first warning of its kind by a manufacturer.

July 19: The FDA said antidepressant packaging should carry warnings that they may cause a fatal lung condition in newborns whose mothers took SSRI antidepressants during pregnancy. Migraine sufferers also need to be warned that combining migraine drugs with SSRIs could result in a life-threatening condition called serotonin syndrome.

August: In August, the Archives of General Psychiatry published a study by Mark Olfson, MD, MPH; Steven C. Marcus, PhD; David Shaffer, MD, on Antidepressant Drug Therapy and Suicide in Severely Depressed Children and Adults. The study determined that children taking antidepressants were 1.52 times more likely to attempt suicide and 15 times ore likely to succeed in the attempt than those not taking the drugs.

September: A study came out in the Public Library of Science Medicine journal. The study was done by psychiatrist David Healy and his team of researchers. The study found that the psychiatric drug Paxil raises the risk of severe violence in a small percentage of people. The researchers looked at clinical trial data from the manufacturer of the drug, GlaxoSmithKline, and found a higher rate of hostile behavior (0.38 percent to 0.66 percent) in patients taking Paxil than in patients taking other antidepressants.

October: A study was published in Behavioral Neuroscience entitled Differential Responsiveness to Fluoxetine During Puberty, which involved injecting “adolescent” and adult hamsters with varying doses of fluoxetine (Prozac), found that even on low doses, 40% more likely to become aggressive than those on placebo.

October: The journal Pharmacotherapy published a study entitled Illicit Use of Specific Prescription Stimulants Among College Students: Prevalence, Motives, and Routes of Administration, about illicit use of stimulants among college students. Researchers at Northeastern University, led by Northeastern University Pharmacy Professor Christian Teter, found that 8.3% of students had abused prescription stimulants sometime during their life and 5.9% within the last year. Nearly 40% of the students that abused stimulants reported they snorted prescription stimulants. About of the students who abused stimulants in the last year had abused Adderall while the rest had abused Ritalin or drugs in the same class as Ritalin. In the press release that ran in Newswise (news release website), Professor Teter stated that one possibility for the overwhelming prevalence of illicit Adderall use may be the fact that it is the most commonly prescribed brand-name stimulant in the U.S. Stories on this article ran in several news sources, including a United Press International wire.

October 12: The New England Journal of Medicine published study, Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimers Disease, found that antipsychotic drugs used to control agitation and aggression in people with Alzheimers disease are no more effective than placebos for most patients, and put them at risk of serious side effects, including confusion, sleepiness and Parkinsons like symptoms.

October 18: The Australian Therapeutic Goods Administration (equivalent to the FDA) ordered manufacturers of ADHD drugs, Ritalin, Strattera and dexamphetamine to add stronger warnings to their information packaging, because of complaints that Ritalin caused headache, nausea, anorexia, somnolence and depression; Strattera caused aggression, and dexamphetamine caused agitation, tachycardia (rapid heartbeat), hypertonia (abnormally tight muscles), hyperkinesia (muscle spasm) and insomnia.

October 23: Dr. Peter Schlegel presented a study at the American Society for Reproductive Medicine conference in New Orleans that determined that while two men were taking antidepressants, their sperm counts dropped dramatically to almost zero, but recovered to healthy levels whenever their drugs were suspended.

October 25: The FDA and Wyeth, the manufacturer of the antidepressant Effexor, announced that doctors should limit the number of Effexor pills they prescribe patients to reduce the risk of overdose. Overdosing on any antidepressant can be fatal but there may be a greater risk of deadly overdose associated with Effexor than with other SSRI antidepressant.

November: The British Journal of Psychiatry published a new analysis of new antidepressant trials lasting 8 to 12 weeks involving children and adolescents suffering severe depression. Researchers found that 5% of children taking new-generation antidepressants were involved in self-harm or suicidal events, compared with 3% cent of those taking placebo. Dr. Bernadka Dubicka of the University Department of Child and Adolescent Psychiatry, Royal Manchester Childrens Hospital, and others conducted the study.

November: The journal Epidemiology, published a study entitled Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital [defects from birth] Malformations. Researchers from Aarhus University in Denmark found that pregnant women who take the newer type of antidepressants, such as Prozac, are more likely to have babies with birth defects than mothers who dont take these drugs.

November 6: The UK Medicines and Healthcare Products Regulatory Agency, announced that it was updating the product information for methylphenidate (Ritalin to advise about serious cardiovascular adverse effects and to recommend that methylphenidate not be used in children or adolescents with known serious structural cardiac abnormalities.

November 27: The FDA has issued a public health advisory which warns that people receiving treatment with methadone have died and suffered life threatening side effects because of overdoses, including slow or shallow breathing and dangerous changes in heart beat that may not be felt by the patient.

November 30: The obstetric (Obstetrics is the branch of medicine which deals with pregnancy and child birth) practice committee of the American College of Obstetricians and Gynecologists (Gynecologists are doctors that specialize in the female reproductive system and disorders that can occur with it) issued a statement that pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects.

December 13: The FDA held a hearing into the relationship between antidepressants and suicide in those 18-25 years of age (young adults). The FDA Psychopharmacological Committee heard testimony from about 75 people who slammed the FDA for having the information 15 years ago about suicide/violence risks and failed to act. The committee voted to extend the black box warning to ages 18 to 25.

2007

February: The Substance Abuse and Mental Health Services Administration released a report (from data collected by the Drug Abuse Warning Network) that determined that among other prescription drugs, anti-anxiety drugs have high overdose rates. From 2004 to 2005, overdoses involving tranquillizers such as Xanax and Valium rose 19%. Overdoses from methylphenidate, a stimulant and the primary ingredient in Ritalin, doubled between 2004 and 2005.

February 21: The FDA directed ADHD drug manufacturers to distribute “patient friendly” guides to consumers warning about serious psychiatric and cardiovascular problems, including stroke, heart attack, sudden death and psychotic reactions caused by ADHD drugs.

February 23: Health Canada advised consumers not to use a product called Sleepees, because it was found to contain an undeclared drug estazolam, which can be habit-forming when used for as little as a few months. Estazolam belongs in the class of drugs known as benzodiazepines (minor tranquilizers like Valium and Xanax). [i] The side-effects associated with the use of products containing estazolam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

March: The New Zealand Intensive Medicines Monitoring Programme (New Zealand government drug surveillance program, the New Zealand equivalent of the FDA) urged health professionals to monitor patients on the anti-psychotic drug Clozapine after a review found five people have died after taking it.

March 15: The National Center on Addiction and Substance Abuse at Columbia University issued a report on youth drug abuse. The report concluded that hundreds of thousands more students are abusing prescription drugs including Ritalin, Adderall and OxyContin than were during the early 1990s.

March 14: The FDA announced that all sleeping pills, including Ambien and Lunesta, can cause the dangerous side effect of “sleep-driving,” which is driving while not fully awake and having no memory of doing so, and may also cause life-threatening allergic reactions. The FDA told manufacturers to write letters to doctors to notify them of the new warnings, and all prescription sleeping pills now will come with special brochures called “Medication Guides” that spell out the risks for patients in easy-to-understand language.

April: The Australian Therapeutic Goods Administration issued an Adverse Reactions Bulletin stating that atypical antipsychotics may cause neuroleptic malignant syndrome (NMS). They had received 85 reports of NMS for Clozapine, 49 reports for Olanzapine (Zyprexa), 45 reports for Risperidone and there were another 46 reports for other anitpsychotics.

April 5: The Therapeutic Goods Administration (TGA, Australian equivalent to the FDA) requested that the makers of the sleeping drug Stilnox (known as Ambien in the United States, strengthen the current warning about mixing the medicine with alcohol. This request comes in the wake of more than 500 complaints about Stilnox including reports of sleepwalkers crashing cars, falling off balconies, smoking, painting and having sex after popping a pill.

April 18: Health Canada advised consumers not to use a product called Eden Herbal Formulations Serenity Pills II, because it was found to contain an undeclared drug estazolam, a habit-forming psych drug when used for as little as a few months. Estazolam belongs in the class of drugs known as benzodiazepines. Eden Herbal Formulations Serenity Pills II is promoted as a herbal product to relieve sleeping difficulty. [ii] The side-effects associated with the use of products containing estazolam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

April 25: In the UK, the National Institute for Health and Clinical Excellence (NICE) issued a warning to doctors about prescribing the antidepressant venlafaxine (Effexor), recommending its use only after two other antidepressants had been used and failed.

April 25: Doctors were warned to be aware of the higher risk of fatal overdoses, cardiotoxicity, and potentially intolerable side effects in patients taking the serotonin and noradrenaline reuptake inhibitor (antidepressant). For new patients, Effexor should be considered only once two other antidepressants have been tried. In all cases, GPs must ensure hypertension is controlled before prescribing Effexor, and patients on the drug must receive regular blood pressure checks and monitoring for cardiac dysfunction. The drug is contraindicated in patients with a high risk of serious cardiac arrhythmias and recent myocardial infarction. The UK Medicines and Healthcare Products Regulatory Agency (MRHA) warned that fatality rates in single overdose cases range from 10% (according to the drug’s manufacturer) to 27% (reported to the UK ADROIT database). Fatal doses have been as low as 2 grams, involving seizure, coma, or cardiac effects. The percentage of overdoses involving more than one drug range from 57-67%. The MHRA also could not rule out drug-induced suicidality, particularly for 18-29 year-olds. Effexor may be associated with a higher rate of some side effects, such as nausea, dizziness, headache and withdrawal reactions.

May 2: The FDA officially extended the age group for the black box warning about antidepressant inducing suicide from 18 to 24.

June 14: Health Canada further advised consumers not to use Optimum Health Care SleePlus TCM or BYL SleePlus, because the products contain clonazepam, habit-forming within a few months of use. Clonazepam is like Valium and is a benzodiazepine. [iii] The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

June: The Australian Therapeutic Goods Administration issued an Adverse Reactions Bulletin stating that a range of cardiac disorders are associated with the use of the antipsychotic, Clozapine. A boxed warning alerting prescribers has been placed on the product information. Prescribers have been warned that potentially fatal myocarditis (inflammation of the heart muscle) may develop after commencement of Clozapine.

July 9: “Cures killing hundreds” was the headline in The Daily Telegraph in Australia, which reporting that the Therapeutic Goods Administration (Australia’s equivalent of the FDA) has revealed that hundreds of Australians have died and thousands more suffered gruesome side effects after taking anti-psychotic drugs. An Australian law firm is taking on drug giant Eli Lilly in a class action for a group of Australians who suffered side effects after taking the anti-psychotic drug Zyprexa. The article cites CCHR ally lawyer Simon Harrison, stating, “We are now in the double figures with clients from Zyprexa and we are seeing a number of alleged problems� The problems vary from inadequate policing of the medication to the alleged side effects of the medication not being conveyed.” [iv]

July 18: Health Canada is advising consumers not to use the sleep supplement product Optimum Health Care Sleep Easy, because the product contains the undeclared drug clonazepam, a tranquilizer. Health Care Sleep Easy has a different name but has the same formulation as Optimum Health Care SleePlus TCM and BYL SleePlus, which were the subject of a Health Canada public advisory issued on June 14, 2007. All of these products are promoted as sleeping aids and are not authorized for sale in Canada. [v] The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

August: The Therapeutic Goods Administration issued an Adverse Reactions Bulletin about newer antipsychotic agents can cause extrapyramidal side effects, EPS (involuntary movements and muscle rigidity). There had been 3,775 reports for Clozapine and 1,203 reports for Olanzapine (Zyprexa). About one third of patients experiencing EPS had not recovered.

[i] “Health Canada advises consumers not to use herbal sleep supplement Sleepees which contains a habit-forming drug,” Health Canada Advisory, 23 Feb. 2007.

[ii] “Herbal sleep supplement found to contain habit-forming drug,” Health Canada Advisory, 18 April 2007.

[iii] “Sleep Supplements Found to Contain Habit-forming Drug,” Health Canada Advisory, 14 June 2007.

[iv] Clare Masters, “Cures Killing Hundreds,” Daily Telegraph, 9 July 2007

[v] “Sleep Supplements Found to Contain Habit-forming Drug,” Health Canada Advisory, 18 July 2007.

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