Product Recall: Azithromycin - MedWaste Management Product Recall: Azithromycin - MedWaste Management

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Product Recall: Azithromycin

Azithromycin (or Zithromax, Zmax) is an antibiotic used to treat a wide variety of mostly bacterial infections. Its indications include bronchitis, ear infections, community-acquired pneumonia, acute bacterial sinusitis, pharyngitis/tonsillits, urethritis, cervitis, genital ulcer disease, and acute bacterial exacerbations of chronic obstructive pulmonary disease. In 2011, approximately 40.3 million individuals in the U.S. received and outpatient perscription for azithromycin. Azithromycin is considered by the World Health Organization to be an essential medicine.

Risky Side Effects:

Common side effects are nausea, headache, and diarrhea.

Risky side effects can include severe allergic reactions that include hives, swelling, difficulty breathing, and anaphylaxis. In rare cases, azithromycin can cause radiation recall dermatitis.

On 3/12/2013, the FDA issued a Safety Announcement about Azithromycin, following a New England Journal of Medicine study that compared the risks of cardiovascular death in patients treated with four different antibacterial drugs (azithromycin, amoxicillin, ciprofloxacin (Cipro) and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and the risk of death from any cause, in patients treated with a 5-day course of azithromycin (Zithromax)  and levofloxacin (Levaquin), compared to persons treated with amoxicillin, ciprofloxacin, or no drug.

FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms

The problem noted was a prolongation of the QT interval. This affects the heart’s electrical cycle. Severe disturbance the QT interval may lead to cardiac failure and/or death. QT prolongation can affect any patient prescribed to Zithromax.

Patients already presenting with heart complications that are prescribed azithromycin are especially at risk for sudden death. There is also a higher risk for patients who have a family history with heart disease. The risk of sudden death is minimal, but Doctors have have suggested Zithromax recall to be an appropriate response.

Why was it Recalled?

While a Zithromax recall for all of the medication has not been issued,  Zithromax recalls were issued for specific lots or batches.

Mostly, the reasons for recalls have been Inadequate Investigation of Consumer Complaints.

Other reasons cited for recalls were Failed Impurities/Degradation Specifications.(One batch was manufactured with high dosages of the active ingredient and was a public safety hazard) Lack of Assurance of Sterility and Stability, and Penicillin Contamination.

There have been 11 Azithromycin recalls from 2012-2017. In 2016,  PD-Rx Pharmaceuticals conducted two Class II nationwide recalls of azithromycin tablets. In total, more than 62,500 bottleswere included in the 2016 recall, according the U.S. Food and Drug Administration.

Additional Information for Healthcare Professionals:

When considering treatment options for patients already at risk for cardiovascular events, consider the risk of fatal heart rhythms with azithromycin. Also, the potential risk of QT prolongation with azithromycin should be appropriately considered.

Additional Information for Patients taking Azithromycin:

*Seek immediate care if you experience dizziness, shortness of breath, irregular heartbeat or fainting while taking azithromycin.

*Do not stop taking azithromycin without discussion with your health care professional. Talk to your health care professional if you have any concerns about your perscribed drugs.

*Report any adverse effects with the FDA MedWatch program.

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