Streptomycin, dihydrostreptomycin, streptomycin/penicillin and dihydrostreptomycin/penicillin chemical review

Completed

Streptomycin and dihydrostreptomycin are antibiotic compounds used to treat bacterial infections.

Streptomycin is an aminoglycoside antibiotic derived from Streptomyces griseus bacteria. Dihydrostreptomycin is a derivative of streptomycin. The differences between streptomycin and dihydrostreptomycin are small and so, while assessing them individually, the APVMA refers to them throughout the report as (dihydro) streptomycin.

Penicillin is the generic name for a large group of β-lactam antibiotics derived from several species of Penicillium bacteria. Penicillin was not assessed individually in this review but as an active constituent in combination products with (dihydro) streptomycin.

Work plan

Work plan

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

Chemicals

  • Streptomycin/Penicillin
1. Nomination

1. Nomination

Phase status

Completed

The APVMA reviewed the use of streptomycin, dihydrostreptomycin and the combination products of streptomycin/penicillin and dihydrostreptomycin/penicillin in food-producing animals because of concerns about efficacy, possible risks to the public from residues in food, and the potential for residues in meat from treated animals to harm Australian meat and offal exports.

In 1997, the APVMA (formerly the NRA) began the review of (dihydro) streptomycin and (dihydro) streptomycin/penicillin combination products after the Meat Research Corporation and the Victorian Department of Natural Resources and Environment advised of concerns. These concerns were about the efficacy of combination products and the possible risk to the Australian trade in meat from streptomycin residues in meat and offal from treated food-producing animals.

2. Prioritisation

2. Prioritisation

Phase status

Completed
3. Scoping and work plan

3. Scoping and work plan

Phase status

Completed
4. Notice of reconsideration

4. Notice of reconsideration

Phase status

Completed
5. Assessment

5. Assessment

Phase status

Completed
6. Proposed regulatory decision

6. Proposed regulatory decision

Phase status

Completed
7. Consultation

7. Consultation

Phase status

Completed
8. Final regulatory decision

8. Final regulatory decision

Phase status

Completed

In 1999, the APVMA released the (Dihydro) streptomycin/penicillin combination products and (dihydro) streptomycin products review final report. We were not satisfied that the use of (dihydro) streptomycin/penicillin in combination was as effective as penicillin alone, or that the continued use (dihydro) streptomycin products—alone or in combination—would not be an undue risk to Australian trade in meat and offal.

The key findings of the final review report were as follows:

  • Combination injectable (dihydro) streptomycin/penicillin products should no longer be used in food-producing animals. Using the combination of (dihydro) streptomycin and penicillin, when penicillin alone was an effective treatment, had the potential to lead to overuse of the (dihydro) streptomycin and promote antibiotic resistance.
  • The use of (dihydro) streptomycin/penicillin combination products, even at recommended label rates, had the potential to lead to residue violations.
  • Injectable products containing (dihydro) streptomycin should no longer be used in food-producing animals, as there was insufficient data to establish suitable withholding periods. The continued use of these products in food-producing animals could not be supported on the grounds of residues and trade.

In the report recommended:

  • cancelling the use of (dihydro) streptomycin and penicillin in combination, for use in food-producing animals
  • cancelling the use of (dihydro) streptomycin in food-producing animals (the APVMA will only allow limited off-label use of these products under veterinary permit; for more information, see the advisory note below)
  • strengthening warnings on product labels by amending product labels to specify that (dihydro) streptomycin and (dihydro) streptomycin/penicillin combination products should not be used in food-producing animals, with effect from 30 June 1999
  • withdrawing the maximum residue limits (MRLs) for poultry (the review found that the residue data did not support the existing MRLs for poultry).

On 1 October 1999, the APVMA cancelled the registration of four (dihydro) streptomycin/penicillin combination products at the request of the registrants.

Advisory note: the APVMA believes that using (dihydro) streptomycin products for certain purposes under veterinary permit is necessary on the grounds of human health, animal welfare and trade. These uses include the removal of the carrier state of leptospirosis in cattle, pigs and sheep, the treatment of campylobacteriosis in bulls and the treatment of live cattle for export to countries that require it. For these conditions, the APVMA has issued permits for the off-label use of (dihydro) streptomycin.

9. Implementation

9. Implementation

Phase status

Completed
Publication archive

Publication Archive

Type Title Publication date
Report (Dihydro) streptomycin/penicillin review final report March 1999
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