Primary Care

CMECNE

FDA Drug Safety Communication: Clarithromycin and Increased Potential Risk of Heart Problems or Death in Patients With Heart Disease

Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the FDA recommendations on the use of clarithromycin in patients with stable coronary artery disease
2. State the infections where clarithromycin may be used

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from April 8 2018 through April 8 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:

FDA released a drug safety advisory and follow up review, advising caution before prescribing the antibiotic clarithromycin to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later

A review of the results from the CLARICOR trial, a 10-year follow-up study of patients with stable coronary heart disease from a large clinical trial, observed this serious safety issue
More deaths were observed in patients who underwent a two-week course of clarithromycin that became apparent after ≥1 year of follow up
- No clear explanation was apparent as to why clarithromycin would lead to more deaths than placebo
- Observational studies have been conflicting
The FDA
- Has added a new warning about this increased risk of death in patients with heart disease that also advises prescribers to consider using other antibiotics in such patients
- Has added the study results to the clarithromycin drug labels
- Will continue to monitor safety reports in patients taking clarithromycin
FDA recommends the following

Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.

KEY POINTS:

Clarithromycin is used to treat many types of infections including
- Those affecting the skin, ears, sinuses and lungs
- Helicobacter pylori
- Mycobacterium avium complex (MAC) infection which can be seen in individuals with HIV
In the CLARICOR study, there was increased all-cause mortality and CVD during 10 year follow up, primarily in patients not on statin at entry
FDA recommends that patients talk to their provider about benefits and risks of clarithromycin and any alternative treatments
Patients should
- Be alert to signs or symptoms of stroke or MI
- Should not stop taking medications without medical discussion and oversight
Adverse events or side effects should be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program
- Online: www.fda.gov/MedWatch/report
- Download form 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

Learn More – Primary Sources:

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded clinical trial

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FDA Drug Safety Communication: Clarithromycin and Increased Potential Risk of Heart Problems or Death in Patients With Heart Disease