European Medicines Agency Recommends Suspension of the Rosaglitazone Containing Drugs Avandia, Avandamet and Avaglim

September 24, 2010 – Please find below a very significant announcement by the European Medicines Agency (EMEA) regarding the market suspensions of Avandia throughout the European Union.

09/23/2010 – The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months.

Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor.

Doctors should stop prescribing rosiglitazone-containing medicines. Patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment.

The current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on 9 July 2010 following the availability of new studies questioning the cardiovascular safety of the medicine.

Since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review. Consequently, the use of rosiglitazone was restricted to a second-line treatment and contra-indicated in patients with heart failure or a history of heart failure when it was first granted a marketing authorisation as Avandia in 2000.

Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced.

The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.

The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.

The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.

Notes

* Rosiglitazone was initially authorised as Avandia in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim.

* The review of the marketing authorisations of Avandia, Avandamet and Avaglim was initiated on the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, following the publication of two studies on 28 June 2010. References for the two studies are as follows: Graham DJ et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA doi:10.1001/jama.2010.920. Nissen SE et al. Rosiglitazone revisited. An updated meta analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med doi:10.1001/archinternmed.2010.207.

FDA Significantly Restricts Access to the Diabetes Drug Rosiglitazone [Avandia]

September 23, 2010 – We present here a very significant announcement by the American Food and Drug Administration (FDA) in its original. Please note that the European Medicines Agency (EMEA) also today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet, and Avaglim, which have been available  on the market throughout the European Union.

09/2372010 – The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (Rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks, said FDA Commissioner Margaret A. Hamburg, M.D. We are seeking to strike the right balance to support clinical care.

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under this REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (Pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.

The agency anticipates that the REMS will limit use of Avandia significantly. Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research.

Also today, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the companys clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDAs review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings.

In addition, the agency halted the GSKs clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs. The FDA may take additional actions after the independent re-analysis of RECORD is completed.

Recall of Products Marketed as Dietary Supplements Containing Aromatase Inhibitors

September 20, 2010 – We learn today from a press release by the American Food and Drug Administration (FDA)  the following (text adapted):

Aromatase inhibitors in products marketed as dietary supplements are being  recalled, including the products Arom-X, Arom-X UTT, Arom-XL, 4-AD, Decavol, ArimaDex, Clomed, Off Cycle II Hardcore, and Reversitol.

All these products marketed as dietary supplements contain aromatase inhibitors, commonly known as “ATD.” Adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events.

The FDA concludes that products containing aromatase inhibitors have a reasonable probability of resulting in permanent impairment of a body structure or function in at risk consumers. FDA has notified manufacturers that these products do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act. Many of these products are or had been sold nationwide, both in retail stores and via the internet directly to consumers. Some have been discontinued but some online retailers may still have remaining inventory that they are offering for sale.

Recommendation by FDA:

Consumers who have any of these products in their possession should stop using it immediately. If consumers experience any adverse side effects due to its consumption they should contact a physician. Photos of the recalled products are available through links on the company press releases, seen below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Programm at www.fda.gov/MedWatch/report.htm.

For your information, please find below the press releases of the individual companies concerned with this recall.

[09/15/2010 – Press Release – Kilosports, Inc]
[09/13/2010 – Press Release – Genetic Edge Technologies, Inc]
[09/16/2010 – Press Release – Advanced Muscle Science, Inc]
[09/16/2010 – Press Release – Fizogen Precision Technologies, Inc]
[09/16/2010 – Press Release – iForce Nutrition LLC]