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The antibiotic Biaxin (clarithromycin) is linked to a higher rate of severe heart problems and death in patients with heart disease.

FDA Warning: Biaxin Heart Problems, Death

February 22, 2018 — The FDA issued a Safety Warning after a study found that patients with Coronary Artery Disease (CAD) who were prescribed a 2-week course of Biaxin (clarithromycin) had an increased risk for severe heart problems and death. These side effects may occur years later.

Biaxin Side Effects

  • Severe heart problems
  • Heart damage
  • Heart attack
  • Stroke
  • Death

What is Biaxin?

The antibiotic Biaxin (clarithromycin) has been approved in the U.S. since 1995, but it is not approved for heart disease. It is sold by Takeda Pharmaceuticals and used primarily for the treatment of infections affecting the skin, eats, sinuses, lungs, HIV, and more.

Study Finds Increased Death Rate in Biaxin Patients

The FDA warned doctors about the risks of Biaxin after the CLARICOR clinical trial unexpectedly found higher rates of severe heart problems and death among patients with pre-existing heart disease who were followed for at least 1 year.

The FDA updated the label with the following warning information:

“FDA added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients.”

Heart Attack or Stroke Symptoms

  • Chest pain
  • Trouble breathing
  • Pain or weakness on one side of the body
  • Pain or weakness in one part of the body
  • Slurred speech