The US Food and Drug Administration (FDA) has added a new warning to clarithromycin labels in light of a clinical trial which concluded the antibiotic increases the risk of death years later in patients with heart disease. Under the new recommendations, the drug should not be prescribed to patients with this condition. Heart disease is the leading cause of death in the United States, accounting for one in every four deaths, according to figures from the Centers for Disease Control and Prevention.
Clarithromycin is a macrolide antibiotic used to treat a range of bacterial infections, including those affecting the skin, ears, sinuses, lungs and other parts of the body. It has been available in pharmacies for more than 25 years under the brand name Biaxin and is also available as a generic. The drug works by preventing the growth of bacteria and is sometimes used to treat Mycobacterium avium complex (MAC) infection, a lung infection that often afflicts people with HIV.
The FDA made its recommendations following a large clinical trial called the CLARICOR trial, which found an unexpected increase in mortality among patients with coronary heart disease who received a two-week course of clarithromycin. In 2005, the FDA issues another statement about the possible dangers of clarithromycin to people with heart disease after a trial in Denmark. At the time, the agency did not issue any recommendation about the use of the drug as previous trials had not demonstrated a “statistically significant effect on mortality”.
The reason for the increased rate of death compared to the placebo group was unclear, and the FDA noted the recent studies do not provide sufficient data to determine whether the results of the trial could be applied to patients who do not have heart disease.
Patients with heart disease who are currently on a course of antibiotics to treat an infection were advised to speak to their healthcare provider about the benefits and risks of clarithromycin and possible alternative treatments. Patients were also urged not to stop taking their antibiotics or heart medicine without first speaking to a healthcare professional as this could be damaging to their health.
Which other drugs to avoid if you have heart disease...
Any medication that could increase your blood pressure can prove dangerous for patients with heart disease as they raise the risk of heart attack or stroke. These include certain (but not necessarily all):
- Non-steroidal anti-inflammatory drugs (NSAIDs) - such as Motrin (ibuprofen) or Aleve (naproxen).
- Cough and cold medications - some of these medications contain NSAIDs.
- Migraine medication - some migraine medications function by constricting blood vessels in the head to ease the pain, but this can increase blood pressure.
- Weight loss medications - these can also increase blood pressure.
If you are unsure about which medication you can take if you have heart disease or another medical condition, make sure you speak to your healthcare provider about your options.