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 Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat 
(August 24, 2009)

Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply; Vaccine Approved as a Hib Booster Dose  (August 2009)

Shortage of Erythromycin Ophthalmic Ointment (5 mg/gram) reported (August 2009)

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)(August 2009)

Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)  June, 2009

Propylthiouracil-Induced Liver Failure (June 2009)

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide (May 2009) 

FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products (May 2009)

FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice (April 09, 2009)

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely  (April 2009)

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans (April 2009)

Updated FDA Action Plan on Plan B (levonorgestrel) Tablets  (April 2009)

Information for Healthcare Professionals: Ceftriaxone (marketed as Rocephin and generics) (April 2009)

FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice (April 2009)

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs (March 2009)

Update of Safety Review.  Follow-up to the March 27, 2008 Communication about Ongoing Safety Review of Montelukast (Singulair)  (January 2009)

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications (December 16, 2008)

FDA Approves 2008-2009 Flu Vaccines (August 5, 2008)

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-Feeding (May 28, 2008)

Relenza (zanamivir) MedWatch alert (April 2, 2008)

Early Communcation About an Ongoing Safety Review of Montelukast (Singulair) (March 28, 2008)

FDA issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone (March 11, 2008)

Tamiflu (oseltamivir phosphate) MedWatch alert (March 4, 2008)

FDA Approves Zyrtec for Nonprescription Use in Adults and Children (November 21, 2007)

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (September 28, 2007)

FDA Approves Lamasil for Pediatric Treatment of Scalp Ringworm (September 28, 2007)

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents (August 22, 2007)

FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events (February 21, 2007)

Public Health Advisories:

Use of Codeine by Some Breastfeeding Mothers May Lead to Life-Threatening Side Effects In Nursing Babies (August 17, 2007)

Nonprescription Cough and Cold Medicine Use in Children (August 15, 2007)

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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