Gentamicin is an IV antibiotic that has changed little since it was introduced in 1963. Together with its sister drugs Tobramycin, Amikacin and Netilmicin, they make up the Aminoglycoside (AG) class of drugs.

The AG class of drugs have significant ability to cause loss of hearing and balance function (ototoxicity (OT)) and loss of kidney function (nephrotoxicity (NT)) in many patients. The risk of OT and NT is increased in patients with:

  • Pre-existing kidney function issues
  • Once daily AG dosing regimens
  • Extended lengths of therapy, i.e., greater than 14 days

AG antibiotics are widely prescribed for simple and complex infections. Comprehensive clinical monitoring programs are required to obtain successful microbiological outcomes without concomitant OT or NT. Skilled physicians (most commonly infectious disease (ID) specialists) and competent clinical pharmacists are required to

  • Decide which patients are candidates for AG therapy
  • Create individualized care plans to monitor the AG therapy drug levels and renal function parameters
  • Respond to changes in patient’s clinical conditions and laboratory results

In many areas of the country, more than 50% of AG regimens are not managed by ID physicians and clinical pharmacists. Unfortunately, it is this group of patients that frequently experience significant side effects which maybe long-lasting or permanent.

There are several less toxic alternatives to the AG group available in America today. In 2017, there should be very few reasons to expose an at-risk patient to AG therapy.  If the AG group of IV antibiotics is truly needed for a patient’s therapy, customized dosing regimens and care plans should be able to greatly reduce the risk of toxicity.

The team at ITEWG has managed over 2000 episodes of AG therapy and are uniquely qualified to help physicians, patients, pharmacists and hospitals who are contemplating or are facing AG therapy based litigation evaluate risk and develop strategies to manage these complex issues.

Michael Rigas, Pharm.D.