Clarithromycin Risk for Patients with Coronary Heart Disease
February 22, 2018 – The U.S. FDA has issued a safety communication regarding the use of the antibiotic clarithromycin, also known by the brand name Biaxin®. A 10-year study has shown that patients with existing coronary heart disease may have an increased risk of heart problems or death after taking clarithromycin, with the effects observed sometimes years after use of the drug.
Based on the study results, the FDA has added a warning to clarithromycin drug labels, and advises prescribers to consider alternative medicines for patients who have coronary heart disease. Patients who have heart disease should be informed of the risks of taking clarithromycin. Physicians should also ensure these patients are familiar with the signs and symptoms of cardiovascular problems.
Patients should inform their healthcare providers if they have heart disease, and seek medical help immediately if they experience symptoms of heart attack or stroke. Patients should not discontinue medication without first speaking to their healthcare provider.
The FDA requests that physicians and patients report any side effects that may be caused by clarithromycin to the MedWatch program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.