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Propofol: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches, update 2

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Safety advisory - potential bacterial contamination

30 May 2014

This updates the statement published on 9 May 2014 to include details about ongoing investigations into this issue, including results of TGA testing of affected batches, and details of confirmed cases of contamination with Ralstonia bacteria.

Health professionals, hospitals and health facilities are advised that batches of a widely used intravenous anaesthetic drug, propofol, may include some vials that have been contaminated with Ralstonia species.

There have been reports of patients having developed sepsis following administration of 1% propofol injection.

In consultation with the TGA, the Australian distributor of Provive MCT-LCT 1% (propofol 1%) emulsion for injection in 20 ml vials (ARTG 162318), AFT Pharmaceuticals, has quarantined two batches as a precautionary measure. The affected batch numbers are:

  • A030906 (expiry date 08/15)
  • A030907 (expiry date 08/15).

At this time, no batches of any of the drugs listed below are subject to a recall.

As a precautionary measure, health professionals are advised, where possible, to avoid use of all sizes and all batches of the AFT-distributed Provive and Sandoz Propofol 1% products as listed below pending further investigation into this issue:

118940 Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 1000mg/100mL emulsion for injection vial (distributed by AFT)
118938 Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 200mg/20mL emulsion for injection vial (distributed by AFT)
162319 PROVIVE MCT-LCT 1% propofol 500mg/50mL emulsion for injection vial (distributed by AFT)
118939 Claris Lifesciences Australia Pty Ltd PROVIVE 1% propofol 500mg/50mL emulsion for injection vial (distributed by AFT)
162320 PROVIVE MCT-LCT 1% propofol 1000mg/100mL emulsion for injection vial (distributed by AFT)
162318 PROVIVE MCT-LCT 1% propofol 200mg/20mL emulsion for injection vial (distributed by AFT)
148870 PROPOFOL SANDOZ propofol 200mg/20mL emulsion for injection vial
148872 PROPOFOL SANDOZ propofol 1000mg/100mL emulsion for injection vial
148871 PROPOFOL SANDOZ propofol 500mg/50mL emulsion for injection vial

Hospitals should consider seeking alternative sources of propofol 1% to the drugs listed above. Where there are no suitable alternatives, health professionals should satisfy themselves that the benefits outweigh the risks to the patient.

Ralstonia species are Gram-negative bacteria. It may take several days for a blood culture to become positive and may be difficult for a laboratory to identify. Possible initial identifications include Stenotrophomonas, Burkholderia and Pseudomonas species of bacteria.

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Information for consumers

This medicine is only used in hospitals and certain health facilities.

Hospitals and health facilities have been contacted and provided with further information about this issue, including details of the quarantine process.

If you have any questions or concerns about this issue, talk to your health professional.

TGA investigations

The TGA is working with State and Territory health departments to gather further information regarding the reported cases of sepsis and to identify the specific organism(s) suspected of causing the infection.

In particular, the TGA is investigating the strength of the evidence linking these propofol products with the reported cases of sepsis.

As part of these investigations, the TGA has tested samples of the affected batches for microbial contamination. This testing included tests for sterility and bacterial endotoxins.

No microbial contamination was detected in the tests for sterility conducted on the two quarantined batches. Eight batches (including the quarantined batches) were tested for bacterial endotoxins. Test results did not indicate the presence of bacterial endotoxins in the samples that were tested.

Additional bacterial contamination testing (separate to sterility testing) was also conducted and no bacterial contamination was detected in the portions of samples that were tested.

The TGA is also in the process of testing the inside surface of the plastic flip-off seal and the subsequently exposed surface of the rubber stopper of a number of vials from the quarantined batches to assess if these surfaces could be a potential source of contamination.

The TGA has received some results and is awaiting more from external laboratories and will review all data as part of these investigations.

Final laboratory test results are expected to be available by 6 June.

The TGA is also carefully examining the manufacturing site data to identify relevant information. Documentation reviewed to date is consistent with the quarantined batches being manufactured in accordance with the required specifications.

Summary of confirmed cases of Ralstonia bacteraemia

TGA has been informed of eight confirmed cases of Ralstonia bacteraemia in Australian patients who had received propofol 1% injection since 1 April 2014. A detailed assessment of these cases is underway to determine the likelihood that the propofol was the cause of the infection. Four of these cases are from Queensland, three from South Australia and one from Victoria. The bacteria have been identified as: Ralstonia mannitolilytica (six cases), Ralstonia picketti (one case) and Ralstonia insidiosa (one case).

The date of propofol 1% administration is known for each of these eight cases and ranges from 1 April 2014 to 27 April 2014. The time between propofol 1% administration and onset of bacteraemia is known for the eight cases and ranges from one hour to 23 days.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.