Betaseron is used to treat Multiple Sclerosis (MS) by helping the body fight off viral infections. It is made from the human protein interferon. Although betaseron will not cure MS, it has been known to decrease the frequency of relapse.

In 1993, the FDA approved betaserone for treatment of MS. It is prescribed to patients who have had a clinical episode and an MRI that confirms the presence of MS. In 2005, the FDA sent a warning to physicians that stated that betaseron may be linked to some dangerous side effects such as serious hepatic injury, injection site necrosis and thoughts of suicide.

Studies found that betaseron can cause serious hepatic injury such as autoimmune hepatitis and liver damage, which has led to hepatic failure and may require a liver transplant. While taking betaseron, liver testing has been recommended in regular intervals to insure that irreversible liver damage has not occurred.

Injection site necrosis has been seen in about five percent of patients. This is skin damage that occurs near the injection site and has occurred during the first four months of therapy, and has also been seen even a year after treatment.

During a clinical trial of betaseron, researchers found four suicide attempts and one completed suicide while patients were taking the drug. Other side effects were flu-like symptoms and other injection site reactions.
Less serious side effects may include:

  • Weakness
  • Headache
  • Muscle pain or weakness
  • Sleep problems (insomnia)
  • Stomach pain
  • Swelling in your hands or feet
  • Skin rash
  • Irregular menstrual periods

Serious side effects may include:

  • Depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself
  • Bruising, swelling, oozing, or skin changes where the injection was given
  • Weight changes, pounding heartbeats, feeling too hot or cold
  • Fever, chills, body aches, flu symptoms
  • Nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)

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