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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  05/16/2019
 
Trade Name:  Fragmin
 
Generic Name or Proper Name (*):  dalteparin sodium
 
Indications Studied:  Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month and older
 
Label Changes Summary:  *Safety and effectiveness for the treatment of symptomatic VTE have been established in pediatric patients aged 1 month and older. *Use is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate studies in pediatric patients aged 1 month and older with symptomatic VTE. *The frequency, type and severity of adverse reactions observed were generally consistent with those observed in adults. *Use preservative-free FRAGMIN in neonates and infants. *Serious adverse reactions including fatal reactions and the "gasping syndrome' occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications. *Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. *When prescribing Fragmin multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including FRAGMIN multiple-dose vials and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. *Information on dosing, adverse reaction, PK parameters, and clinical trials.
 
PREA(P):  P
 
Sponsor:  Pharmacia & Upjohn
 
NNPS:  FALSE
 
Therapeutic Category:  Anticoagulant
 
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