OBJECTIVE: To summarise the reported @entity8193 cases associated with @entity2449 from the Australian Therapeutic Goods Administration (TGA) and estimate the incidence of @entity2449 -associated @entity8193 (MALA) in Australia. METHOD: All " @entity8193 " cases associated with @entity2449 and reported to the TGA between January 1971 and October 2014 were included. Data extracted included @entity1 demographics, medical history and co-existing conditions, @entity2449 dosage and relevant pathology results. RESULT: A total of 152 cases of suspected MALA were included in this study. For 20 @entity1 the outcome was unknown. There were 23 @entity1 (n=132, 17.4%) reported as deceased. Plasma @entity880 levels were higher in non-survivors (p=0.02). Thirty-five @entity1 (n=132, 26.5%) were reported to have at least one pre-existing contraindication to the use of @entity2449 ; this proportion was not different between @entity1 who died or survived. @entity8 was the most common contraindication. Approximately 75% of @entity1 were reported to have at least one clinical condition which might cause @entity520 . @entity2449 dosage, plasma @entity880 and serum @entity1011 were not correlated. Based on the cases reported to the TGA, the incidence of MALA in Australia was estimated to be 2.3 (95% CI, 1.5-3.1) cases per 100,000 @entity1 -years between 1997 and 2011. CONCLUSION: Pre-existing clinical conditions, such as @entity8 , and acute illnesses associated with @entity8193 were frequently reported in the cases of MALA. The estimated incidence of MALA was lower than in most previous studies in other countries, probably due to the nature of spontaneous reports to the TGA.

Adverse event notifications implicating @entity2449 with XXXX in Australia.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity8 :: ('MESH:D007674', 'Disease') :: ['Renal impairment', 'renal impairment'] @entity8193 :: ('MESH:D000140', 'Disease') :: ['lactic acidosis'] @entity520 :: ('MESH:D000138', 'Disease') :: ['acidosis'] @entity880 :: ('MESH:D019344', 'Chemical') :: ['lactate'] @entity1011 :: ('MESH:D003404', 'Chemical') :: ['creatinine'] @entity2449 :: ('MESH:D008687', 'Chemical') :: ['Metformin', 'metformin']
@entity8193 :: (MESH:D000140,Disease) :: ['lactic acidosis']
