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Methylene Blue Injection

[17 July 2014]

Products Affected - Description

Methylene Blue 10 mg/mL, American Regent
1 mL vial (NDC 00517-0301-10)
10 mL vial (NDC 00517-0310-10)
1 mL ampule (NDC 00517-0372-71)
10 mL ampule (NDC 00517-0373-70)

Reason for the Shortage

  • Akorn had methylene blue on back order due to increased demand for the product.1
  • American Regent has methylene blue on back order due to manufacturing delays.2

Available Products

Methylene Blue 10 mg/mL, Akorn
1 mL vial (NDC 17478-0504-01)
10 mL vial (NDC 17478-0504-10)

Estimated Resupply Dates

American Regent has all methylene blue presentations on back order and the company cannot estimate a release date.2

Implications for Patient Care

Methylene blue is a dye used in a variety of procedures such as lymph node biopsy, endoscopic evaluation of lesions, and urologic evaluations and pulmonary nodule evaluations.3 Methylene blue is an unapproved drug without FDA approved labeling, however the package insert for methylene blue notes it is indicated for drug induced methemoglobinemia.4 Methylene blue has also been used to treat methemoglobinemia due to toxic chemicals or substance abuse.3

Safety

Ensure appropriate dosing and indications when alternative dyes are used.

Alternative Agents & Management

  • Consider reserving a supply of methylene blue for the treatment of methemoglobinemia. A recommended stocking level is five 10 mL vials to treat 1 patient.5
  • There is no single dye that can replace methylene blue. Potential options include isosulfan blue and indigo carmine. The table summarizes potential alternatives to methylene blue for selected clinical scenarios.
Table. Potential Alternatives to Methylene Blue for Selected Clinical Situations
 

Use

Treatment Regimen

Comments

Methemoglobinemia

Supportive care

Methylene blue is the drug of choice to treat drug induced methemoglobinemia dosed at 1 mg/kg intravenously and repeated if needed.3

Lymph node and vessels delineation

Isosulfan blue: usual dose is 0.5 mL subcutaneously into 3 interdigital spaces of each extremity per study (maximum 3 mL).

Sentinel lymph node biopsy for patients with neoplasms such as breast cancer or other delineation of lymphatic vessels such as patients with lymphedema or chyluria.6

Endoscopy procedures

Indigo carmine

Methylene blue is used for endoscopic evaluation in patients with Barrett’s esophagus or gastroesophageal reflux disease.3,7

Urology

Indigo carmine

Methylene blue is used for endoscopic evaluations of ureteral or pelvic injuries.3

Indigo carmine is used during cystoscopy and ureteral catheterization as a marker dye.8,9

References

  1. Akorn (personal communications). March 5, April 29, June 27, August 26 and 30, September 16 and 25, October 28, December 10, 2013; and January 27, April 24, and July 14, 2014.
  2. American Regent (personal communications and website). March 5, April 29, June 27, August 26 and 30, September 16 and 26, October 28, December 9, 2013; and January 27 April 24, and July 14, 2014.
  3. American Regent,(personal communications and website). March 5, April 29, June 27, August 26 and 30, September 16 and 26, and October 28, 2013. 
  4. Methylene Blue. In McEvoy, GK, Snow EK, et al., Eds. AHFS Drug Information Online. Accessed September 17, 2013.
  5. Akorn. Methylene blue injection [product information]. Lake Forest, IL, Akorn, 2011.
  6. The University of Utah Poison Control Center. Antidotes for Poisoned Patients.
  7. Mylan Institutional LLC. Isosulfan blue 1% injection [product information]. Rockford, IL, Mylan Institutional LLC, 2013.
  8. Kiesslich R, Neurath MF, Galle PR. Chromoendoscopy and magnifying endoscopy in patients with gastroesophageal reflux disease. Useful or negligible? Dig Dis.2004;22(2):142-7.
  9. Indigotindisulfonate sodium. In McEvoy, GK, Snow EK, et al., Eds. AHFS Drug Information Online. Accessed September 17, 2013.
  10. Akorn. Indigo carmine injection [product information]. Lake Forest, IL, Akorn, 2013

Updated

Updated July 17, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 17, 2013 by Erin Fox, PharmD, FASHP, Director, Drug Information Service, and Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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