Actos

[Pioglitazone]

Side Effects & Drug Interactions
ADVERSE REACTIONS

In worldwide clinical trials, over 3700 patients with type 2 diabetes have been treated with ACTOS. In U. S. clinical trials, over 2500 patients have received ACTOS, over 1100 patients have been treated for 6 months or longer, and over 450 patients for one year or longer.

The overall incidence and types of adverse events reported in placebo-controlled clinical trials of ACTOS monotherapy at doses of 7.5 mg, 15 mg, 30 mg, or 45 mg once daily are shown in Table 7.

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For most clinical adverse events the incidence was similar for groups treated with ACTOS monotherapy and those treated in combination with sulfonylureas, metformin, and insulin.

There was an increase in the occurrence of edema in the patients treated with ACTOS and insulin compared to insulin alone. In the ACTOS plus insulin trial (n= 379), 10 patients treated with ACTOS plus insulin developed dyspnea and also, at some point during their therapy, developed either weight change or edema. Seven of these 10 patients received diuretics to treat these symptoms. This was not reported in the insulin plus placebo group.

The incidence of withdrawals from clinical trials due to an adverse event other than hyperglycemia was similar for patients treated with placebo (2.8%) or ACTOS (3.3%). Mild to moderate hypoglycemia was reported during combination therapy with sul-fonylurea or insulin. Hypoglycemia was reported for 1% of placebo-treated patients and 2% of patients when ACTOS was used in combination with a sulfonylurea. In combination with insulin, hypoglycemia was reported for 5% of placebo-treated patients, 8% for patients treated with 15 mg of ACTOS, and 15% for patients treated with 30 mg of ACTOS (see PRECAUTIONS, General, Hypoglycemia).

In U. S. double-blind studies, anemia was reported for 1.0% of patients treated with ACTOS and 0.0% of placebo-treated patients in monotherapy studies. Anemia was reported for 1.6% of patients treated with ACTOS and 1.6% of placebo-treated patients in com-bination with insulin. Anemia was reported for 0.3% of patients treated with ACTOS and 1.6% of placebo-treated patients in combination with sulfonylurea. Anemia was reported for 1.2% of patients treated with ACTOS and 0.0% of placebo-treated patients in combi-nation with metformin.

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