ACTOS Drug Information and Drug Recall Page

ACTOS Drug Information Page

Updated 08/09/2010 12:50:37 AM

Product	Source	Date	Link	Data
ACTOS	Health Canada	2008-12-19	ACTOS-Health Canada-2008-12-19	OTTAWA - Health Canada is informing diabetic patients taking Actos (the brand name for the prescription drug pioglitazone hydrochloride) of recent changes to the prescribing information for this product. Health Canada has worked with the manufacturer to strengthen the labelling around heart failure and emphasize proper use. Actos is used to treat type 2 diabetes mellitus (non-insulin dependent diabetes). While previous labelling addressed the risk of heart failure, a safety assessment completed by Health Canada on Actos identified the need for new restrictions to better manage the risk.
ACTOS	MHRA	2007-12-3	ACTOS-MHRA-2007-12-3	MHRA has issued drug updates: Recombinant human erythropoietins: new prescribing advice Rosiglitazone and pioglitazone: cardiovascular safety Dosulepin: measures to reduce risk of fatal overdose ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy Short-acting � agonists: myocardial ischaemia Varenicline: possible effects on driving, and psychiatric illness* NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks Aprotinin: suspension of Marketing Authorisations Lumiracoxib: suspension of Marketing Authorisations Strontium ranelate: risk of severe allergic reactions Talc for pleurodesis: risk of adverse events
ACTOS	MHRA	2007-10-1	ACTOS-MHRA-2007-10-1	MHRA has issued drug updates: Piroxicam: new restrictions, including specialist initiation Ketoprofen and ketorolac: gastrointestinal risk Inhaled corticosteroids: pneumonia Pneumovax II: tolerability of re-vaccination Bisphosphonates: osteonecrosis of the jaw Lorazepam: reduction of recommended maximum daily dose Botulinum toxin products: rare but serious risk Rosiglitazone and pioglitazone: cardiovascular safety and fracture risk Lumiracoxib and hepatotoxicity: prescribing update
ACTOS	FDA	2007-8-14	ACTOS-FDA-2007-8-14	After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning. The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments.
ACTOS	FDA	2007-8-14	ACTOS-FDA-2007-8-14	Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). There were more than 8100 patients in the pioglitazone-treated groups and over 7400 patients in the comparator-treated groups. The duration of pioglitazone treatment was up to 3.5 years. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.
ACTOS	Health Canada	2007-5-7	ACTOS-Health Canada-2007-5-7	Eli Lilly Canada, after consultation with Health Canada, would like to bring to your attention important safety information concerning ACTOS� (pioglitazone hydrochloride) tablets, used in the treatment of type 2 diabetes mellitus and the occurrence of bone fractures in female patients. Eli Lilly Canada has recently received an analysis of the pioglitazone clinical trial database with a special focus on fractures reported as adverse events. There were 8,157 patients in the pioglitazone-analysis group and 7,442 patients in the non-TZD comparator analysis groups. Findings from these clinical trials showed that 1.8% of pioglitazone-treated patients experienced at least one event of bone fracture versus 1.6% of patients treated with comparator drugs (other diabetes medicines or placebo). Eli Lilly Canada will continue to monitor fractures as an adverse event in both the clinical trial and spontaneous reporting database.

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