Risperdal (risperidone tablets) is an atypical antipsychotic medication that's used to treat symptoms of schizophrenia, including hallucinations, hearing voices, sensing things that are not there, and unusual suspiciousness. The medication may also be used alone or with lithium or divalproex for short-term treatment of mixed or manic episodes in adults who have a condition called Bipolar I disorder. Bipolar disorder is a mental illness that causes extreme mood swings. Risperdal is made by Johnson & Johnson subsidary Janssen, L.P. and was approved by the U.S. Food and Drug Administration (FDA) in 1994.
Risperdal Settlement, Lawsuits
In November 2013, Johnson & Johnson agreed to resolve criminal and civil investigations into the marketing of Risperdal and other widely-prescribed medications by paying over $2.2 billion. This was one of the largest penalties ever levied against a company for healthcare fraud. According to the agreement, Johnson & Johnson pled guilty to misbranding Risperdal for unapproved uses, as well as for paying kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes.
In 2012, an Arkansas jury determined that Johnson & Johnson downplayed and hid risks associated with Risperdal. The trial judge ordered Johnson & Johnson to pay more than $1.2 billion in fines for nearly 240,000 violations of the state's Medicaid fraud law.
Risperdal Health Risks
Risperdal and other antipsychotic medications can cause serious problems such as:
- Neuroleptic Malignant Syndrome (NMS): A life-threatening nervous system problem, which can cause high fever, stiff muscles, sweating, fast or irregular heart beat, change in blood pressure, and confusion. NMS can also affect your kidneys and is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
- Tardive Dyskinesia (TD): A movement problem. Call your healthcare professional right away if you get muscle movements that cannot be stopped.
- High blood sugar and diabetes: Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
- Stroke: Strokes have occurred in older patients treated for mental illness from dementia. Risperdal is not approved for this use.
Other serious side effects from Risperdal use may include:
- Low blood pressure seen as dizziness
- Increased heartbeat
- Possible fainting
- Persistent erection
- Thrombotic thrombocytopenic purpura (seen as fever and bruising)
- Increase or decrease in body temperature
- Difficulty swallowing
The most common side effects from Risperdal use include:
- Uncontrolled movements
- Upset stomach
- Runny nose
- Vision changes
- Saliva increase
- Abdominal pain
- Inability to control urination
- Weight gain
What Should I Tell My Healthcare Professional?
Before you start taking Risperdal, tell your healthcare professional if you:
- Have or had heart problems
- Have or have had seizures
- Have or had diabetes or increased blood sugar
- Have or had liver disease
- Have an obstruction of your intestines
- Have Reye's syndrome
- Have a brain tumor
- Are trying to become pregnant, are already pregnant, or are breast-feeding
- Drink alcohol
- Have a condition called phenylketonuria
Interactions With Other Drugs and Foods
Because certain other medications can interact with Risperdal, you should talk first with your healthcare professional about all prescription and non-prescription medicines you are taking. Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:
- Blood pressure medicines
- Levodopa and medicines called dopamine agonists
- Fluoxetine and paroxetine
In addition, you should avoid drinking alcohol while taking Risperdal.
Is There Anything Else I Need to Know About Taking Risperdal?
Dizziness, and sometimes fainting, caused by a drop in blood pressure may occur with Risperdal, especially when you first start taking this medicine or when the dose is increased. Risperdal may impair judgment, thinking, or motor skills. You should be careful when operating machinery, including automobiles, until you know how Risperdal affects you. It's important to avoid overheating and dehydration while taking Risperdal, because Risperdal use may make it harder to lower your body temperature.
Getting Legal Help
While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."
Treating Risperdal complications, including gynecomastia, can require expensive surgeries and medical care. A product liability suit can allow patients to receive compensation for these expenses. Since product liability law is a complicated area of the law, it's in your best interests to consult with an experienced attorney for a free claim evaluation before deciding on a course of action.