Safety Advisory

 

HPS’ compounding department routinely reviews formulations to ensure they are efficacious and meet patient requirements. As such, HPS Pharmacies wish to advise that it will no longer manufacture Bonney’s Blue surgical dye.

Investigations into the constituents that make up Bonney’s Blue have found that gentian violet (also known as Crystal Violet) is toxic on skin contact and inhalation, emits toxic vapours, is a possible sensitiser, and has been flagged as a potential reproductive hazard with prolonged repeat exposure.

No products are being recalled. However, HPS Pharmacies wishes to advise that the product will be phased out, and production ceased from early August 2016.

HPS Pharmacies are aware that Bonney’s Blue is used as a marker and topical sterilising agent and to aid in the diagnosis of fistulas. Possible alternatives to Bonney’s Blue include the use of permanent markers (for pre-surgical incision planning) and other common topical sterilising agents such as methylene blue (for fistula diagnosis).

Please retain this notice in a prominent position, including other related business units. Should you require further information or advice on suitable alternatives, please contact HPS Pharmacies’ compounding department on (08) 8193 9110.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Pfizer Australia on (02) 9850 3397.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

References:

  1. Au W. Pathak S. Collie CJ, Hsu TC. Cytogenetic toxicity of gentian violet and crystal violet on mammalian cells in vitro. Mutat Res. 1978; 58(2–3): 269-76.
  2. Burton C, Spady D, Turnbull L, Rennie R, Forgie S. Can skin marker pens, used pre-operatively to mark surgical sites, transfer bacteria? Infect Cont Hosp Ep. 31(2): 192-4.
  3. Kikuchi S, Kenagy RD, Gao L, Wight TN, Azuma N, Sobel M, et al. Surgical marking pen dye inhibits saphenous vein cell proliferation and migration in saphenous vein graft tissue. J Vasc Surg. 2016; 63(4): 1044-50.
  4. Pensylvania Patient Safety Authority. Surgical Site Markers: Putting Your Mark on Patient Safety. Pa Patient Saf Advis. 2008; 5(4): 130-5.
  5. Sim FCJ, Angadi D, Jarvis GE, Porteous M. Assessing clarity and erasability of commercially available pens for surgical site marking: a comparative study in human volunteers. Patient Saf Surg. 2016; 10: 11.
  6. Tadiparthi S, Shokrollahi K, Juma A, Croall J. Using marker pens on patients: a potential source of cross infection with MRSA. Ann R Coll Surg Engl. 2007; 89(7): 661–4.

Subscribe Knowledge Centre Updates

Enter your details to receive Knowledge Centre updates