The FDA Advisories and Press Statements listed here may have special relevance to the care of children. For a comprehensive listing of Advisories, Press Releases, and Talk Papers, visit the FDA Web site at www.fda.gov. No official endorsement of the content by the AAP is provided or should be inferred.

News Releases, Statements, and Safety Alerts:

FDA warns pregnant women not to use certain migraine prevention medicines (May 6, 2013)

FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or andenoidectomy  (February 20, 2013)

Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After
Report Of Death (February 26, 2013)

FDA approves Gleevec for children with acute lymphoblastic leukemia (January 25, 2013)

FDA approves Fycompa to treat seizures (October 22, 2012)

Treating Children With Cancer (September 27, 2012)

FDA Expands Caution About SimplyThick (September 18, 2012)

Revatio (sildenafil): Drug Safety Communication - Recommendation Against use in Children (August 30, 2012)

FDA approves first drug formulated for children with rare brain tumor (August 29, 2012)

FDA warns of risk of death from codeine use in some children following surgeries (August 15, 2012)

Benzocaine and Babies: Not a Good Mix (May 31, 2012)

FDA warns consumers about counterfeit version of Teva's Adderall (May 29, 2012)

Fentanyl Patch Can be Deadly to Children (FDA Consumer Update) (April 19, 2012)

FDA clears first single use face mask for children (September 28, 2011)

Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
(July 11, 2011)

FDA issues final guidance for liquid OTC drug products with dispensing devices (May 4, 2011)

FDA approves Actemra to treat rare form of juvenile arthritis (April 15, 2011)

Antipsychotic Drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns (February 22, 2011)

FDA Approves Head Lice Treatment for Children and Adults (January 18, 2011)

FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate) (December 17, 2010)

Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children (December 14, 2010)

FDA approves pediatric use of chemical poisoning treatment (September 9, 2010)

Propylthiouracil-Boxed Warning Added (April 21, 2010)

Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available (April 13, 2010)

FDA Requires Device Manufacturers to Include Information on Pediatric Populations (March 31, 2010)

FDA Approves Pneumococcal Disease Vaccine with Broader Protection (February 24, 2010)

Zyprexia (olanzapine): Use in Adolescents (January 29, 2010)

FDA Office of Pediatric Therapeutics

(Visit this site for summaries of pediatrics study reviews and the latest pediatric exclusivity
labeling changes)

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