The black box warning on Risperdal outlines the increased risk of mortality (death) in elderly patients with dementia and states that Risperdal is not approved to treat these patients.
Serious side effects include tardive dyskinesia, stroke, seizures and erections that last several hours. The medication carries a black box warning for increased death in elderly patients.
Antipsychotic Black Box Warning (full text)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
you should know that risperidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking risperidone.
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Risperidone can affect your hormones and sometimes causes sexual problems (in men or women). It can also affect periods. These effects are not common and happen in less than 1 in 100 people. If you would like to start a family then talk to your doctor if you have any of these problems or if you are worried.
Very rarely risperidone can cause severe allergic reactions. Go to hospital if you have difficulty breathing or swelling of your face or throat. In rare cases, risperidone can cause a long-lasting and painful erection (called priapism). If this happens, you will need to be treated in hospital.
Risperidone is an atypical antipsychotic agent associated with tachycardia and acute dystonic reactions. Toxic Mechanism: Risperidone antagonises the mesolimbic dopamine (D2), serotonin and alpha 1 + 2 receptors.
The bottom line
Common risperidone side effects include sleep changes, nausea, and dry mouth. Weight gain, coordination issues, and fainting are also possible. More serious risperidone side effects include movement problems, priapism, and NMS. Discuss ways to manage or limit side effects with your healthcare provider.
Risperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use. Tell your doctor if you have ever had: heart disease, high blood pressure, heart rhythm problems, stroke or heart attack; diabetes (or risk factors such as obesity or family history of diabetes);
Medications may have a black box warning if they have the potential to cause serious harm, hospitalization, or even death. You should take the warnings highlighted in these boxes with the utmost importance. Healthcare providers should take careful consideration before prescribing medications with black box warnings.
The United States Food and Drug Administration issued a Black Box warning in October 2004 after placebo-controlled trials of antidepressant medications found an increased risk of suicidal thoughts and behaviors among children and adolescents taking antidepressant medications relative to placebo.
Starting in 2010, Johnson & Johnson became the subject of thousands of lawsuits by men alleging that Risperdal use caused them to experience a condition known as gynecomastia or growth of excessive breast tissue. This change is said to be due to elevated prolactin levels caused by taking risperidone.
Risperdal can also cause movement disorders that worsen over time. The disorders may be permanent, even after the person stops taking Risperdal.
Side-effects of risperidone may include sleepiness, agitation, anxiety, headache, trembling, excessive saliva, stiffness, leg restlessness, dizziness and fast heart rate.
Risperidone is used to treat schizophrenia, bipolar disorder, or irritability associated with autistic disorder. This medicine should not be used to treat behavioral problems in older adults who have dementia. This medicine is available only with your doctor's prescription.
The mortality rate in the drug-treated patients was approximately 4.5% compared to a rate of approximately 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be cardiovascular (for example, heart failure, sudden death) or infectious (pneumonia)”.
Fentanyl transdermal systems contain a high concentration of fentanyl which has a high potential for abuse and an associated risk of fatal overdose caused by respiratory depression.
In 2004, the Food and Drug Administration (FDA) issued a black-box warning on antidepressants indicating that they were associated with an increased risk of suicidal thinking, feeling, and behavior in young people.
In October 2004, the FDA required a so-called “black box warning” of this risk to be printed on the labels of all antidepressant drugs. It was implemented in January 2005. Two years later, the FDA extended the same warning to include young adults, again based on industry studies.
Black box warnings, also called boxed warnings, are required by the U.S. Food and Drug Administration for certain medications that carry serious safety risks. Often these warnings communicate potential rare but dangerous side effects, or they may be used to communicate important instructions for safe use of the drug.
Celexa and Lexapro also carry risks for much more dangerous side effects. Serious side effects include abnormal bleeding, seizures and visual problems. The FDA requires the drugs' labels to include a black box warning for an increased risk of suicide. Other side effects include birth defects.
The Black Box depicts data such as how fast your car was going, the position of the throttle, brake application, airbag deployment, seatbelt use, steering angles and a range of other factors as they were about 20 seconds before, during and 20 seconds after the crash.