NovoSeven is an injection that is used to treat or prevent bleeding in people with hemophilia A, hemophilia B or factor VII deficiency. NovoSeven is a man-made protein that helps to clot blood. NovoSeven was approved for these uses in 1999 and costs approximately $7,500 per dose.

Off-label uses of NovoSeven have been linked to serious side effects. These are uses that have not been approved by the FDA and have proven more dangerous than helpful. One study found that NovoSeven had been used almost exclusively for off-label purposes. Some of the uses that NovoSeven has been prescribed for are cerebral hemorrhages and acute injuries.

Side effects that may arise from off-label uses of NovoSeven are stroke, heart attack and potentially death. Nearly 400 adverse events have been linked to NovoSeven—many of which were serious.

Serious side effects may include:

  • Fever
  • Any bleeding that will not stop
  • Feeling like you might pass out
  • Urinating less than usual or not at all
  • Sudden numbness or weakness, especially on one side of the body
  • Sudden headache, confusion, problems with vision, speech, or balance
  • Pain or swelling in one or both legs

Less serious side effects may include:

  • Headache
  • Joint Pain
  • Nausea, vomiting
  • Swelling
  • Mild itching or rash
  • Pain, redness, swelling, or irritation where the medicine was injected
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