Food and Drug Administration Update for Pediatric Health Care Professionals

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2006;12(5) 

In This Article

Safety Alerts and Labeling Modifications

On March 2, 2006 the FDA and Actelion notified health care professionals of changes in the labeling for bosentan (Tracleer®) to highlight potential drug-induced hepatotoxicity. Patients should have monthly liver function tests (AST/ALT). Values three to five times the upper limit of normal should result in holding or reducing the dose until pre-treatment levels are achieved. Patients with values greater than five times, but less than eight times, the upper limit of normal should have doses held, and patients with values greater than eight times the upper limit of normal should not continue to receive bosentan.[1]

On March 30, 2006, the FDA issued a Public Health Advisory for Diastat AcuDial® after receiving reports of cracks in the applicator tips.[1] The advisory recommended that patients or family members inspect the prefilled applicators to look for damage or leaking of the gel. The manufacturer (Valeant Pharmaceuticals) has provided specific directions for inspecting the applicators on their website at or patients/families may call 1-877-361-2719 for further assistance.

The new iPLEDGE program for patients using isotretinoin (Accutane® or generic brands) was implemented on March 1, 2006.[1] This program is designed to reinforce patient education about the risk for teratogenicity associated with the use of this medication. In addition to registering with iPLEDGE, patients must comply with requirements for providing informed consent, participating in counseling about the risks of therapy, and for women of childbearing age, completing the required pregnancy testing. For more information on the program, prescribers or patients may contact the iPLEDGE call center at 1-866-495-0654 or review the information available on-line at

In March, the FDA also released an alert to notify prescribers of the risk for acute phosphate nephropathy associated with the use of oral sodium phosphate solutions, such as Fleet Phospho-soda,® for bowel cleansing. Elderly patients, as well as those with existing kidney disease or decreased intravascular volume are at higher risk. Patients taking medications that reduce renal perfusion or function, such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers or nonsteroidal anti-inflammatory drugs are also at higher risk for acute phosphate nephropathy.[9]

On April 25, 2006, the FDA issued a Safety Alert for promethazine to call attention to the strengthened warnings in the prescribing information about the potential for fatal respiratory depression in children under 2 years of age.[1] Patient information sheets and the revised promethazine prescribing information is available on the CDER website at

New labeling and Medication Guides were approved on March 2, 2006 for salmeterol xinafoate (Serevent Diskus®) and fluticasone propionate/ salmeteral xinafoate (Advair Diskus®). These changes were made to highlight the potential for bronchospasm in patients receiving salmeterol.[1]

On January 19, 2006, the FDA approved the addition of a black box warning label to topical pimecrolimus (Elidel®) and tacrolimus (Protopic®).[1] The warning highlights the potential risk for cancer after long-term use, based on several case reports and animal studies which suggest an association with these drugs. The FDA also approved Medication Guides to be distributed to patients and their families explaining this new information. The American Academy of Dermatology Association has recently published a review of this issue which includes tips for discussing the use of these products with patients and families.[10]


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