Gelfoam

Last updated on RxList: 8/15/2019
Gelfoam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/15/2019

Gelfoam (absorbable gelatin powder from absorbable gelatin sponge) is a medical device indicated in surgical procedures, including those involving cancellous bone bleeding, as a hemostatic device, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Common side effects of Gelfoam include

  • fever,
  • infection,
  • abscess formation,
  • foreign body reactions,
  • “encapsulation” of fluid, and
  • blood clots.

The minimum amount of Gelfoam should be applied to the bleeding site with pressure until hemostasis is observed. The Gelfoam may be left in place at the bleeding site, when necessary. Gelfoam may interact with other drugs or topical agents. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or breastfeeding before receiving Gelfoam.

Our Gelfoam (absorbable gelatin powder from absorbable gelatin sponge) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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SIDE EFFECTS

There have been reports of fever associated with the use of GELFOAM, without demonstrable infection. GELFOAM may serve as a nidus for infection and abscess formation1, and has been reported to potentiate bacterial growth. Giant-cell granuloma has been reported at the implantation site of absorbable gelatin product in the brain2, as has compression of the brain and spinal cord resulting from the accumulation of sterile fluid.3

Foreign body reactions, “encapsulation” of fluid and hematoma have also been reported.

When GELFOAM was used in laminectomy operations, multiple neurologic events were reported, including but not limited to cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.

Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin products were used in severed tendon repair.

Toxic shock syndrome has been reported in association with the use of GELFOAM in nasal surgery.

Fever, failure of absorption, and hearing loss have been reported in association with the use of GELFOAM during tympanoplasty.

Adverse Reactions Reported From Unapproved Uses

GELFOAM is not recommended for use other than as an adjunct for hemostasis. While some adverse medical events following the unapproved use of GELFOAM have been reported to Pharmacia & Upjohn Company (see ADVERSE REACTIONS above), other hazards associated with such use may not have been reported.

When GELFOAM has been used during intravascular catheterization for the purpose of producing vessel occlusion, the following adverse events have been reported; fever, duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis of specific anatomic areas, asterixis, and death.

These adverse medical events have been associated with the use of GELFOAM for repair of dural defects encountered during laminectomy and craniotomy operations: fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.

Adverse Events Associated With Bone Hemostasis

In a clinical study, 108 patients received GELFOAM Sterile Powder on the cut surface of the sternum during cardiopulmonary bypass surgery, while 107 patients received no treatment on the cut surface of the bone. Table 1 is a summary of medical events reported by at least 1.0% of patients in a treatment group. The most frequently reported events were atrial fibrillation, perioperative event, and wound infection. Events occurring in less than 1.0% of the patients were as follows: anaphylaxis, cardiogenic shock, delirium tremens, infection at the vascular catheter site, unevaluable reaction, sepsis, angina pectoris, atrial arrhythmia, nodal arrhythmia, arteriosclerosis, cardiac insufficiency, cardiac tamponade, cardiomyopathy, deep vein thrombosis, mitral valve disorder, endocarditis, ventricular extrasystoles, heart arrest, hypotension, mesenteric occlusion, superventricular tachycardia, thrombophlebitis, thrombosis, gastrointestinal disorder, gastrointestinal bleeding, increased serum creatinine, dehydration, anemia, thrombocytopenia, abnormal healing, hypovolemia, hypoxia, metabolic acidosis, cerebral infarction, visual hallucinations, stupor, aspiration pneumonia, chest congestion, pleural effusion, pulmonary infiltration, retinal artery occlusion, anuria, UG disorder, abnormal kidney function and menorrhagia.

Table 1: Summary of Medical Events for GELFOAM Sterile Powder when used as a Bone Hemostatic Agent During Cardiopulmonary Bypass Surgery

Medical Event GELFOAM
N=108
Control
N=107
Total
N=215
n % n % n %
Atrial Fibrillation 14 (13) 12 (11) 26 (12)
Wound Infection 6 (6) 1 (0.9) 7 (3.3)
Perioperative Event 4 (4) 5 (4.7) 9 (4.2)
Congestive Heart Failure 4 (4) 0 (0) 4 (1.9)
Ventricular Tachycardia 2 (2) 3 (2.8) 5 (2.3)
Atrial Flutter 2 (2) 0 (0) 2 (0.9)
Peripheral Vascular Disorder 2 (2) 0 (0) 2 (0.9)
Pneumothorax 2 (2) 3 (2.8) 5 (2.3)
Respiratory Failure 2 (2) 2 (1.9) 4 (1.9)
Respiratory Arrest 2 (2) 1 (0.9) 3 (1.4)
Fever 1 (1) 2 (1.9) 3 (1.4)
Heart Block 1 (1) 2 (1.9) 3 (1.4)
Prolonged Wound Drainage 0 (0) 1 (0.9) 1 (0.5)
Cellulitis 0 (0) 2 (1.9) 2 (0.9)
Dyspnea 0 (0) 2 (1.9) 2 (0.9)
Pneumonia 0 (0) 2 (1.9) 2 (0.9)

In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:

  • Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.
  • Giant cell granulomas have been observed at implant sites when used in the brain.
  • Compression of the brain and spinal cord resulting from the accumulation of sterile fluid has been observed.
  • Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence and paresis.
  • The use of absorbable gelatin-based hemostatic agents have been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and blindness due to device migration in the orbit of the eye, during lobectomy, laminectomy and repair of a frontal skull fracture and lacerated lobe.
  • Foreign body reactions, “encapsulation” of fluid, and hemotoma have been observed at implant sites.
  • Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed tendon repair.
  • Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
  • Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.

Read the entire FDA prescribing information for Gelfoam (Absorbable Gelatin Powder)

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© Gelfoam Patient Information is supplied by Cerner Multum, Inc. and Gelfoam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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