"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL® and their caregivers:
Interference With Cognitive And Motor Performance
Inform patients and caregivers that RISPERDAL® has the potential to impair judgment, thinking, or motor skills. Advise caution about operating hazardous machinery, including automobiles, until patients are reasonably certain that RISPERDAL® therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS].
Advise patients and caregivers to notify their physician if the patient becomes pregnant or intends to become pregnant during therapy [see Use In Specific Populations].
Inform patients and caregivers that risperidone and its active metabolite are present in human breast milk; there is a potential for serious adverse reactions from RISPERDAL® in nursing infants. Advise patients that the decision whether to discontinue nursing or to discontinue the RISPERDAL® should take into account the importance of the drug to the patient [see Use in Specific Populations].
Advise patients and caregivers to inform their physicians if the patient is taking, or plans to take, any prescription or over-the-counter drugs, because there is a potential for interactions [see DRUG INTERACTIONS].
Advise patients to avoid alcohol while taking RISPERDAL® [see DRUG INTERACTIONS].
Inform patients with Phenylketonuria and caregivers that RISPERDAL® M-TAB® Orally Disintegrating Tablets contain phenylalanine. Phenylalanine is a component of aspartame. Each 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablet contains 0.84 mg phenylalanine; each 3 mg RISPERDAL® M-TAB® Orally Disintegrating Tablet contains 0.63 mg phenylalanine; each 2 mg RISPERDAL® M-TAB® Orally Disintegrating Tablet contains 0.42 mg phenylalanine; each 1 mg RISPERDAL® M-TAB® Orally Disintegrating Tablet contains 0.28 mg phenylalanine; and each 0.5 mg RISPERDAL® M-TAB® Orally Disintegrating Tablet contains 0.14 mg phenylalanine [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 5/8/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Risperdal Information
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