FDA Warns Against Off-Label Use of Antipsychotic Drugs

The U.S. Food and Drug Administration (FDA) has released a warning to physicians and patients that off-label use of certain drugs called “atypical antipsychotics” could be dangerous to older patients with dementia. Included in the advisory are antipsychotics such as aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), clozapine (Clozaril), and ziprasidone (Geodon). Currently, these drugs are approved to treat schizophrenia and mania. However, clinical studies have found that older patients with dementia who received an antipsychotic regimen had a mortality rate 1.6 to 1.7 times higher than patients who received placebo. In these studies, most deaths were heart related or from infection.

The FDA has requested that manufacturers include a warning on the labels of antipsychotic medications describing the risk of off-label use to older patients with dementia. Patients who are taking an antipsychotic to treat a behavioral disorder associated with dementia should consult their physician about continued use.

Additional information regarding this advisory or the specific medications included in the warning is available on the FDA Web site at: http//www.fda.gov/cder/drug/infopage/antipsychotics/default.htm.

Other FDA Advisories:

Recall of urine processing kit. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the ProbeTec ET Urine Processing Kit, which screens for Chlamydia and gonorrhea. Because the kit may cause false-negative results, the FDA is concerned that some patients might not receive treatment. If left untreated, these infections can worsen or cause further disease transmission and complications in pregnant patients.

Combination therapy may cause hepatitis. Studies have found that healthy volunteers could contract drug-induced hepatitis with marked transaminase elevations after taking simultaneous regimens of rifampin (Rifadin) and ritonavir (Norvir)-boosted saquinavir (Fortovase). The drug’s manufacturer recommends that physicians not prescribe rifampin for patients taking ritonavir-boosted saquinavir. The combination regimen is used as an antiretroviral therapy for human immunodeficiency virus infection.

Warning labels ordered for two eczema medications. The FDA has announced that it will require warning labels for pimecrolimus (Elidel) and tacrolimus (Protopic), topical creams used to manage eczema. Recent studies on animals and limited case studies on humans have found an increased cancer risk associated with the two medications. Although more studies are needed, the FDA recommends that physicians prescribe these medications only as a second-line, short-term therapy for patients unresponsive to other treatments. The FDA also advises physicians to avoid prescribing them to children younger than two years and to persons with weakened immune systems.

AAP Recommends Caring for Children with Special Needs at Home

The Committee on Children with Disabilities of the American Academy of Pediatrics (AAP) has released a clinical report recommending that children with special needs receive care at home—not in a group home or institutional setting. The full report, “Helping Families Raise Children with Special Health Care Needs at Home,” is available on the AAP Web site (http://aappolicy.aappublications.org/cgi/content/full/pediatrics;115/2/507).

The report facilitates permanency planning (i.e., securing a permanent family environment and long-term relationships with caring adults) for persons with special needs. It is geared toward meeting the U.S. Department of Health and Human Services’ goal of having no person 21 years or younger with special needs living in a group home or institution by 2010. Because some families are unable to care for their children at home, the AAP suggests acceptable alternative living situations, such as families who already have children with special needs or parents who work in the health care industry. The Committee also gives suggestions for parents and physicians on how to provide an optimal living situation, home modifications, and transportation to fit each child’s needs; how to find faith and community-based support; and how to help these children transition into adulthood.

Physician-specific recommendations developed by the AAP Committee include the following:

• Address each child’s need for and the availability of appropriate education, including later transition services. Physician advocacy may be necessary to ensure that the patient receives adequate service from the school and to decrease the parents’ burden.

• Identify which support services would most suit each child’s needs, and help families gain access to these services through referral to social service agencies.

• Lobby for increased funding for family support by working with legislators.

• Assist in training caregivers for children with special needs.