Asenza Plus Adverse Reactions

Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse events reported in at least 5% of patients in the controlled 16-week clinical studies between placebo plus a sulfonylurea and pioglitazone (15 mg and 30 mg combined) plus sulfonylurea treatment arms were upper respiratory tract infection (15.5% and 16.6%), accidental injury (8.6% and 3.5%), and combined edema/peripheral edema (2.1% and 7.2%), respectively.
The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24-week study comparing pioglitazone 30 mg plus a sulfonylurea and pioglitazone 45 mg plus a sulfonylurea are shown in the table; the rate of adverse events resulting in study discontinuation between the two treatment groups was 6% and 9.7%, respectively. (See table.)

Click on icon to see table/diagram/image

Pioglitazone: New onset or worsening diabetic macular edema with decreased visual acuity.
Fatal and nonfatal hepatic failure.
Post marketing reports of congestive heart failure have been reported in patients treated with pioglitazone, both with and without previously known heart disease and both with and without concomitant insulin administration.
In post marketing experience, there have been reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure.
Glimepiride: Serious hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome.
Hemolytic anemia in patients with and without G6PD deficiency.
Impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may progress to liver failure.
Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis.
Leukopenia, agranulocytosis, aplastic anemia, and pancytopenia.
Thrombocytopenia (including severe cases with platelet count less than 10,000/mcL) and thrombocytopenic purpura.
Hepatic porphyria reactions and disulfiram-like reactions.
Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH), most often in patients who are on other medications or who have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone.