[06 May 2013]
Products Affected - Description
Amikacin injection, Bedford
250 mg/mL, 2 mL vials, package of 10 (NDC 55390-0226-02)
250 mg/mL, 4 mL vials, package of 10 (NDC 55390-0226-04)
Amikacin injection, Teva
250 mg/mL, 2 mL vials, package of 10 (NDC 00703-9032-03)
250 mg/mL, 4 mL vials, package of 10 (NDC 00703-9040-03)
Reason for the Shortage
- Bedford has amikacin on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.1
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.1
- Hospira discontinued amikacin in May, 2010 due to a raw material shortage.2
- Teva’s product was unavailable due to manufacturing delays.3
- Sandoz discontinued Amikin injection in 2006.4
No presentations are fully available.
Estimated Resupply Dates
- Bedford has amikacin 250 mg/mL 2 mL and 4 mL vials on back order and the company cannot estimate a release date.1
- Teva is allocating amikacin 250 mg/mL 4 mL vials to wholesalers as product becomes available. Emergency supplies of amikacin 4 mL vials are available for drop shipment. Teva has amikacin 250 mg/mL 2 mL vials on back order and the company cannot estimate a release date.3
Implications for Patient Care
- Amikacin is an aminoglycoside antibiotic. It is effective against many Gram-negative bacteria, including some strains resistant to gentamicin or tobramycin.5,6 It is also effective against Staphylococcus aureus and some other Gram-positive bacteria.6 Amikacin is labeled for a variety of indications including bacterial septicemia, burn-related and post-operative infections, serious complicated and recurrent urinary tract infections, and serious bone and joint, intra-abdominal, central nervous system, respiratory tract, and skin and soft tissue infections.5
- Amikacin is the most active aminoglycoside against Mycobacterium avium complex (MAC). It is also effective against other drug-resistant, non-pulmonary Mycobacterium species, including M. abscessus, M. chelonae, and M. fortuitum. Gentamicin and tobramycin have poor activity against these Mycobacterium species. Streptomycin can be considered as part of a multi-drug treatment of drug-resistant Mycobacterium species.6-9
- Amikacin may be the aminoglycoside of choice for serious nosocomial gram-negative infections in areas where resistance to gentamicin or tobramycin is present.8 Amikacin is not degraded by many pathogen-produced enzymes that inactivate other aminoglycosides resulting in drug resistance.5,7
- Amikacin is a second-line treatment for drug-resistant Mycobacterium tuberculosis. Gentamicin and tobramycin are not considered effective treatments of M. tuberculosis. Streptomycin is also a second-line treatment of M. tuberculosis or a potential first-line alternative if other agents are contraindicated.8,9
- Amikacin is produced in 50 mg/mL and 250 mg/mL concentrations. Use caution when switching between amikacin products of different concentrations.8,9
- Target peak and trough concentrations, and timing of concentration measurement vary between aminoglycosides. Perform pharmacokinetic dosing calculations based on the specific agent being used.8,9
- Compounding pharmacies may be offering compounded amikacin products during this shortage. Extreme caution is warranted if a compounded product is used.10 Compounded products are not FDA-approved and FDA has no control over the quality or consistency of the manufacturing process.10,11 Compounding pharmacies may not test every batch of product for drug concentration, sterility, or lack of pyrogens. In July 2001, several patients died from bacterial meningitis after receiving betamethasone injection prepared by a compounding pharmacy.10,12
Alternative Agents & Management
- The choice of an alternative agent must be patient-specific and based on culture, sensitivity, desired tissue penetration, renal function, and site of infection. No single agent can be substituted for amikacin.6,8 Consult an Infectious Disease specialist for patient and infection-specific recommendations. Begin amikacin therapy only if sufficient supplies are available to complete the course of therapy.
- Consider reserving amikacin for use in patients with drug-resistant MAC and other drug-resistant non-pulmonary Mycobacterium species.8,9
- For other uses, consider using other parenteral aminoglycosides, such as gentamicin or tobramycin for susceptible infections. Streptomycin is primarily used as a second-line treatment of Mycobacterium tuberculosis.8,13 Table 1 briefly compares dosing and pharmacokinetics for the available aminoglycosides.
- Bedford (personal communications and website). January 5 and 22, February 4 , 10, and 23, March 2, 9, 23, and 31, April 20, May 18, June 15, July 6 and 29, August 31, September 2, October 15, November 19, December 14, 2009; January 20, February 24, March 12, April 2, May 20, June 1 and 30, July 12 and 28, August 11, 30, and 31, October 26, November 2 and 8, December 10, 14, 21, and 29, 2010; January 11 and 19, February 8, March 8, April 11, 18, and 19, May 3, June 1, 6 and 15, July 6 and 20, August 16, September 19 and 29, October 6 and 20, November 2 and 21, and December 6, 2011; January 10, March 27, April 5, May 29, August 16, November 16, and December 17, 2012; February 12, March 12 and 28, and April 15 and 29, 2013.
- Hospira (personal communications). January 5 and 22, February 4 , 10, and 23, March 2, 9, 23, and 31, April 20, May 18, June 15, July 6 and 29, August 31, September 2, October 15, November 19, December 14 2009; January 20, February 25, March 12, April 2 and 13, May 19, and June 1, 2010.
- Teva (personal communications). January 5 and 22, February 4 , 10, and 23, March 2, 9, 23, and 31, April 20, May 18, June 16, July 6 and 29, August 31, September 2, October 15, November 19, December 14 2009; January 20, February 24, March 12, April 2, May 17, June 29, July 12 and 28, August 3, 11, and 30, September 21, October 13 and 25, December 9 and 13, 2010; January 10 and 19, February 4, and March 8, April 11, May 31, July 7, August 17, September 20, November 3, and December 6, 2011; January 10, February 17, March 27, June 1, August 17, November 20, and December 17, 2012; February 13, March 11, April 2 and 10, and May 6, 2013.
- Sandoz (personal communication). January 1, 2009.
- Amikacin Sulfate [product information]. Bedford, OH: Bedford Laboratories, 2009.
- Gilbert DN, Moellering RC, Eliopoulos GM, Chambers HF, Saag MS. The Sanford Guide to Antimicrobial Therapy 2010. 40th edition. Sperryville, VA: Antimicrobial Therapy, Inc, 2010.
- Gilbert DN, Leggett JE. Aminoglycosides. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 7th edition. Philadelphia, PA: Churchill Livingstone Elsevier, 2010: 359-384.
- Aminoglycosides. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 63-91.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. June, 2011.
- American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406.
- Rusho WJ. Clinical issues and concerns in the use of extemporaneously compounded medications. J Pharm Care Pain Sympt Contr. 1996;4:5-20.
- Meningitis deaths linked to drug shortages. American Society of Health-System Pharmacists Drug Shortage Resource Management Center (accessed on June 9, 2011). Bethesda, MD.
- Aberg JA, Goldman MP, Gray LD, Long JK, eds. Infectious Diseases Handbook. 6th ed. Hudson, OH: Lexi-Comp, 2006.
- Tobramycin Solution for Injection Shortage. American Society of Health-System Pharmacists Drug Shortage Resource Management Center. Accessed June 9, 2011.
Updated May 6, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service. Created July 6, 2010, by David M. Peterson, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT..
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