TABLE 1

Completed PAC-Recommended Labeling Changes, November 2007 through September 2013 (N = 21)

DrugRecommended Labeling Changes
Abilify (aripiprazole)Clarify potential for metabolic and weight effects in the pediatric population
Aldara (imiquimod)Include information about the negative studies in children as well as local skin reactions in the genital area leading to “inability to urinate”
AndroGel (testosterone gel)Include specific information about secondary exposure risk of pubertal development, virilization, and bone effects
Artiss (fibrin sealant, human)Include information on specific ages of those studied in premarketing clinical trials
Asmanex (mometasone furoate)Revise to clearly state that lactose is an ingredient in the excipient powder and harmonize the labeling for all dry product inhalers
Cancidas (caspofungin acetate)Clarify that the hepatobiliary events have been reported
Epiduo (adapalene/benzoyl peroxide)Include the potential for patient hypersensitivity to the product
Flovent HFA (fluticasone propionate)Include dental caries and tooth discoloration to the postmarketing section of the labeling
Kapvay (clonidine hydrochloride)Harmonize labeling with the clonidine IR labeling for AV block and hallucinations
Lamictal (lamotrigine)Include information about suicidality
Provigil (modafinil)Include information about the ADHD pediatric clinical trial data and stronger language that it is not approved for any pediatric indication because of safety issues
Retrovir (zidovudine)Include information about dosing changes to reduce medication errors
Risperdal (risperidone)Clarify potential for metabolic and weight effects in the pediatric population. Include additional information about pediatric use in this class of products
Sandostatin LAR (octreotide acetate)Harmonize the LAR and injection solution versions of the label and include information that no causal association has been established
Serevent (salmeterol xinafoate)Include information about the risk of serious asthma outcomes (asthma-related death, intubations, and hospitalizations) with the use of the class of the LABA
Suprane (desflurane)aInclude ”cardiac arrest” in the postmarketing section of the labeling
Suprane (desflurane)aRevised to clearly state that the use of maintenance of non-untubated pediatric patients be contraindicated
Tamiflu (oseltamivir phosphate)Include information about neuropsychiatric events in the Warnings and Precautions section of the label and in the patient package insert
Topamax (topiramate)Include information about AEs (eg, weight loss, bone mineralization, life-threatening episodes of epistaxis) as well as information about the results of sponsor’s migraine studies in children
Valtrex (valacyclovir hydrochloride)Clarify that central nervous system AEs have been reported in pediatric and adult patients
Zyprexa (olanzapine)Clarify the potential for metabolic and weight effects in the pediatric population. Include information regarding pediatric use in this class of product
  • ADHD, attention-deficit/hyperactivity disorder; AV, atrioventricular; IR, immediate release; LABA, long-acting β-agonist.

  • a These changes resulted from 2 separate PAC meetings and recommendations.