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(kla rith' roe mye sin)[Posted 02/22/2018] AUDIENCE: Health Professional, Internal Medicine, Cardiology, Patient ISSUE: FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDAs recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. The large clinical trial, called the CLARICOR trial, observed an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients had been followed for one year or longer. There is no clear explanation for how clarithromycin would lead to more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not. All the studies had limitations in how they were designed. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not. Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results. Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease. As a result, 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. FDA also added the study results to the clarithromycin drug labels. As part of FDA's usual ongoing safety monitoring of drugs, we are continuing to monitor safety reports in patients taking clarithromycin. BACKGROUND: Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with human immunodeficiency virus (HIV). Clarithromycin is not approved to treat heart disease. RECOMMENDATION: 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. Patients should tell your healthcare professionals if you have heart disease, especially when you are being prescribed an antibiotic to treat an infection. Talk to them about the benefits and risks of clarithromycin and any alternative treatments. Do not stop taking your heart disease medicine or antibiotic without first talking to your healthcare professionals. Doing so could be harmful without your health care professionals' direct supervision. Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred speech.
Before taking clarithromycin,
- tell your doctor and pharmacist if you are allergic to clarithromycin, azithromycin (Zithromax, Zmax), dirithromycin (Dynabac) (not available in the U.S.), erythromycin (E.E.S., E-Mycin, Erythrocin), telithromycin (Ketek), any other medications, or any of the ingredients in clarithromycin tablets or suspension. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking astemizole (Hismanal) (not available in the U.S.),cisapride (Propulsid), colchicine (Colcrys), dihydroergotamine (DHE 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), lovastatin (Mevacor, in Advicor) pimozide (Orap), simvastatin (Zocor, in Vytorin), or terfenadine (Seldane) (not available in the U.S.). Your doctor will probably tell you not to take clarithromycin if you are taking one or more of these medications.
- tell your doctor if you have or have ever had prolonged QT interval (a rare heart problem that may cause fainting or irregular heartbeat) or ventricular arrhythmia (abnormal heart rhythms) or if you have ever had jaundice (yellowing of the skin or eyes) or other liver problems while taking clarithromycin, Your doctor will probably tell you not to take clarithromycin.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); certain benzodiazepines such as alprazolam (Xanax), midazolam (Versed), and triazolam (Halcion); bromocriptine (Parlodel); calcium channel blockers such as amlodipine (Norvasc, in Caduet, in Lotrel), diltiazem (Cardizem, Dilacor, Tiazac), and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka); carbamazepine (Tegretol); certain medications for HIV such as atazanavir (Reyataz), didanosine (Videx), efavirenz (Sustiva, in Atripla), nevirapine (Viramune), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and zidovudine (AZT, Retrovir); certain medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid), quinidine, and sotalol (Betapace); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet) and pravastatin (Pravachol); cilostazol (Pletal); cyclosporine (Neoral, Sandimmune); darifenacin (Enablex); digoxin (Digitek, Lanoxin); erlotinib (Tarceva); eszopiclone (Lunesta); fluconazole (Diflucan); insulin; itraconazole (Sporanox); methylprednisolone (Medrol); omeprazole (Prilosec); oral medications for diabetes such as nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin, in Prandimet), and rosiglitazone (Avandia, in Avandamet, in Avandaryl); phenytoin (Dilantin); ranitidine (Zantac); rifabutin (Mycobutin); rifampin (Rifadin, Rifamate, rifampicin, Rimactane); rifapentine (Priftin); sildenafil (Viagra); tacrolimus (Prograf); theophylline (Theo-Dur); tadalafil (Cialis, Adcirca); tolterodine (Detrol); valproate (Depacon); valproic acid (Depakote); vardenafil (Levitra); and vinblastine. Many other medications may also interact with clarithromycin, so tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have a low level of magnesium or potassium in your blood, or if you have or have ever had an irregular heartbeat, or kidney, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking clarithromycin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clarithromycin.
- stomach pain
- change in taste
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- peeling or blistering skin
- yellowing of the skin or eyes
- extreme tiredness
- unusual bleeding or bruising
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- dark-colored urine
- flu-like symptoms
- fast, pounding, or irregular heartbeat
- muscle weakness such as difficulty chewing, talking, or performing daily activities
- double vision