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FDA Expands Use of HIV Drug Isentress to Children and Adolescents
Date:12/21/2011

most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping (insomnia) and headache. The frequency of these side effects is similar for children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash. The drug should be discontinued if this occurs.

Isentress does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Isentress is made by Whitehouse Station, N.J.-based Merck & Co., Inc.

For more information:

FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm

FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm

CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm

HHS: AIDS News and Resources
http://www.aids.gov/

AIDS Information
http://www.aidsinfo.nih.gov/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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