Drug Regulatory Agency Warnings on psychiatric Drugs

The following is a small sample of drug regulatory agency warnings about psychiatric drug adverse reactions. Many consumers are unaware of these side effects or that they can report such effects to the federal drug regulatory agency.

 

2004:

 

March: The U.S. Food and Drug Administration (FDA) warned that Prozac-like antidepressants (SSRIs) could cause: “Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness that can lead to mania/psychosis], hypomania [abnormal excitement] and mania [exalted feelings, delusions of grandeur].”

 

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.

 

September: The FDA warned that diabetes is a risk for those taking the latest antipsychotic drugs, including Zyprexa.

 

October:  The FDA ordered its strongest “black box” warning to antidepressant packaging, alerting that the drugs could cause suicidal thoughts and actions in children and teenagers.

 

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

 

2005:

 

April: The FDA required a “boxed warning” for packaging of antipsychotic drugs warning of the risk of death in elderly patients with dementia taking them.

 

June: The FDA announced its intention to make labeling changes for Concerta and other stimulants to include, “psychiatric events such as visual hallucinations, suicidal ideation [ideas], psychotic behavior, as well as aggression or violent behavior.”

 

June   The FDA warned that the antidepressant Cymbalta could increase suicidal thinking or behavior in pediatric patients taking the drugs. In October, it also ordered an additional warning of potential liver damage.

 

August: The Australian TGA reported that SSRI antidepressants could cause “new onset of suicidality” in adults and also agitation, nervousness and anxiety. Similar symptoms could occur during withdrawal.

 

August: The European Medicines Agency’s Committee for Medicinal Products issued its strongest warning against pediatric use of antidepressants, stating they could cause suicide attempts and thoughts, aggression, hostility and oppositional behavior and anger.

 

September:  The Agenzia Italiana del Farmaco (Italian drug regulatory agency) ordered a warning label for older type antidepressants advising against use in under 18 year olds; the drugs were also associated with heart attacks in people of any age.

 

October: The FDA withdrew the stimulant 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 ER (extended release), to note it could cause homicidal ideation.

 

December:  Health Canada warned that pregnant women taking Paxil placed their newborn at risk of birth defects.

 

2006:

 

 

February:  The British Medicine and Healthcare Products Regulatory Agency reported the antidepressant Strattera (also used for “ADHD”) was associated with seizures and a potentially dangerous lengthening of time between heartbeats.

 

May:  Health Canada issued new warnings of rare heart risks for all stimulants, such as Ritalin and Adderall, including the risk of sudden death. In August, the FDA ordered a similar warning be added to stimulant drug packaging.

 

July: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy.

 

2007:

 

March:  New Zealand urged health professionals to monitor patients on the antipsychotic drug Clozapine after a review found five people had died.

 

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

 

June:  The Australian TGA reported a range of cardiac disorders (potentially fatal inflammation of the heart muscle) associated with the use of the antipsychotic, Clozapine.

 

September: The FDA reported a warning was added to the antipsychotic Haldol (haloperidol) about the potential risk of death and dangerous heart conditions observed in some patients.

 

2008:

 

June: The FDA issued a warning that antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. It specified that antipsychotics were not indicated for the treatment of this condition and could increase risk of death in some elderly people.

 

 

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

No one should stop taking any psychiatric drug without the advice and assistance of a competent, non-psychiatric medical doctor.