| AVANDIA | | Health Canada | 08-Jul-10 | OTTAWA - In light of recently published scientific studies and an upcoming U.S. Food and Drug Administration ( FDA ) Advisory Committee meeting examining the heart-related (cardiovascular) safety of the diabetes drug rosiglitazone, Health Canada is informing health care professionals and Canadians of the current status of this drug. In Canada, three prescription drugs are currently available that contain rosiglitazone: Avandia (rosiglitazone), Avandamet (contains rosiglitazone and metformin), and Avandaryl (contains rosiglitazone and glimepiride). As a result, the Canadian Product Monographs for Avandia , Avandamet and Avandaryl were updated to include important new restrictions for use. Heart-related events have previously been identified and included in the Canadian Product Monographs for rosiglitazone drugs.
In addition to the restrictions listed above, health professionals are reminded that rosiglitazone is not recommended for use with insulin. |
| AVANDIA | | MHRA | 15-Apr-10 | This is an update to the brief message which was published on the MHRA website on 3 March following enquiries regarding completion of a two-year inquiry by a United States Senate committee, which had questioned the cardiovascular safety of the anti-diabetes medicine, Avandia (rosiglitazone).
Rosiglitazone (Avandia, Avandametâ--¼) is an effective treatment for patients with type 2 (ie non-insulin-dependent) diabetes and belongs to a class of drugs called thiazolidinediones (also called glitazones).
Patients with diabetes are at an increased risk of cardiovascular disorders, including heart failure and ischaemic heart disease, due to the underlying condition.
Warnings about this risk have been present in the product information since it was authorised in 2000.
Furthermore, the patient information leaflet advises about this potential risk, and patients who are at risk of heart failure should talk to their doctor before they start taking Avandia.
A Europe-wide review in 2006 of the available data from clinical trials had provided new data about the risk of heart failure in patients taking rosiglitazone but had also suggested that patients on rosiglitazone may be at an increased of ischaemic heart disease (for example heart attack).
The product information was updated to reflect the findings of this review including addition of information on the risk of ischaemic heart disease.
The findings of this European review and advice to healthcare professionals are detailed in a Drug Safety Update article published in December 2007 (358Kb).
Following this review, the European Medicines Agency (EMA) has advised that the benefits of both rosiglitazone and pioglitazone in the treatment of type 2 diabetes continue to outweigh their risks.
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| AVANDIA | | MHRA | 03-Mar-10 | This safety message, which was issued in response to a review by a United States Senate committee, has been superseded by amessage issued on 15 April 2010.
The review questioned the safety of the anti-diabetes medicine, Avandia (rosiglitazone).
The safety concerns were based on reports of cases of heart attack and heart failure in patients taking the medicine.
Rosiglitazone (Avandia, Avandamet) is an effective treatment for patients with type 2 (ie non-insulin-dependent) diabetes and belongs to a class of drugs called thiazolidinediones (also called glitazones).
Concerns about the cardiovascular safety of rosiglitazone led to a Europe-wide review of all available safety data, including cardiovascular safety data from clinical trials, that was completed in 2007 and concluded that the balance of risks and benefits of rosiglitazone remain favourable in its licensed indications.
This review led to updated prescribing information that included additional warnings that rosiglitazone should be used in patients with ischaemic heart disease only after careful evaluation of every patients individual risk.
The MHRA and European Medicines Agency (EMA) work together to continuously monitor the safety and quality of medicines after they have been licensed so that swift and appropriate action can be taken to protect patients, should the need arise.
Further information about the safety of rosiglitazone and other medicines in this class can be found on the MHRA website.
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| AVANDIA | | FDA | 22-Feb-10 | FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone).
In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis.
These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.
Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010.
The Agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing rosiglitazone.
Patients should continue taking rosiglitazone unless told by their healthcare professional to stop.
Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.
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| AVANDIA | | FDA | 26-Feb-08 | FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate).
The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.
The Medication Guide and current Prescribing Information for Avandia are provided below.
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| AVANDIA | | MHRA | 04-Feb-08 | MHRA has issued drug updates:
Statins: class effects identified
Varenicline: safety update
Carisoprodol and meprobamate: risks outweigh benefits
Duphaston/Duphaston HRT (dydrogesterone): withdrawal of Marketing Authorisation
Herbal safety news: OSAS (intensive body lotion with aloe vera) found to contain steroids
Rosiglitazone: new contraindications and warnings |
| AVANDIA | | MHRA | 03-Dec-07 | 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 ß 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 |
| AVANDIA | | FDA | 14-Nov-07 | FDA informed healthcare professionals of new information added to the existing boxed warning in Avandias prescribing information about potential increased risk for heart attacks.
The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.
At this time, FDA has concluded that there isnt enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options.
Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.
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| AVANDIA | | Health Canada | 06-Nov-07 | Rosiglitazone (AVANDIA®) is no longer approved as monotherapy for type 2 diabetes, except when metformin use is contraindicated or not tolerated.
Treatment with all rosiglitazone products is now contraindicated in patients with any stage of heart failure (i.e., NYHA Class I, II, III or IV).
Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.
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| AVANDIA | | MHRA | 01-Oct-07 | 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 |
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