The FDA ruled to keep the glucose control drug Avandia on the market, with significant restrictions. Dr. Robert A. Vigersky, the immediate past president of The Endocrine Society, offers guidance to type 2 diabetes patients in a video interview available on the Hormone Foundation Web site.

In light of the FDA decision, this educational video provides patients with next steps to consider in their diabetes management, explains the potential health risks of abruptly stopping diabetes medications and guides those in need of an endocrinologist to the Foundation’s referral directory of 3,000 physicians.

The Endocrine Society, the American Diabetes Association and the American Association of Clinical Endocrinologists are issuing a joint news release responding to the FDA ruling.

The Hormone Foundation offers the following advice for people taking medication for type 2 diabetes:

– Do not stop taking your diabetes medications without first discussing it with your health care provider. Stopping your medications can cause poorer diabetes control with higher blood glucose (sugar) levels.

– It is important to maintain good glucose control to avoid the serious short- and long-term health problems of diabetes.

– Other types of diabetes medication are available which your health care provider may consider prescribing.

Source:
Hormone Foundation
Endocrine Society

View drug information on Avandia.

Source: http://www.medicalnewstoday.com/articles/202426.php

In the U.S., GlaxoSmithKline is required to develop a restricted access program. The drug has been restricted to only those patients that cannot control their blood sugar by other means and are unable to take Actos, another drug in the same class.  

The controversy over Avandia has played out over the last few years, with the company saying the drug is safe and others arguing that it increases the risk of heart attack, stroke and death. The FDA also ordered GSK to review the evaluation process it used for Avandia, noting that there were key biases that were overlooked.

Source: http://diabetesnewshound.com/type2/avandia-gets-the-axe/

If you are one of the 600,000 Americans who take Avandia, you need to see your doctor right away. That’s only a small fraction of the 24 million of us here who have diabetes, but anyone who now takes it has an important — and perhaps a life-saving — decision to make.

The U.S. Food and Drug Administration just pulled the major diabetes drug Avandia (rosiglitazone) from the U.S. market — with two exceptions. This government agency responsible for drug safety and efficacy says that people with diabetes who are already on Avandia can keep on using it. But the FDA will let us take it only if we and our doctors swear that they have tried every other diabetes drug and that they and their doctors know how risky Avandia is for their heart.
The FDA’s decision also affects two drugs that combine Avandia with another drug. These are Avandamet, which is Avandia and metformin, and Avandaryl and glimepiride, one of the sulfonylurea drugs.
One study indicates that between when the FDA approved Avandia in 1999 and last year more than 47,000 Americans needlessly suffered heart attacks, strokes, or heart failure — or died. Still, the FDA’s decision yesterday will let people keep on taking Avandia. And the agency admitted that implementing its decision can take months.
The FDA had previously withdrawn our access to drugs years after the agency approved the them. Think thalidomide, which the FDA approved in the late 1950s and pulled in 1961 after mothers who took it gave birth to many children with tragic birth defects. Think too about the diabetes drug Rezulin, which the FDA approved in 1997 and withdrew 11 years later after about 400 people with diabetes died from liver failure.

Rezulin and Avandia are two of the three drugs in the same class, the thiazolidinediones. The third member of this drug class, Actos, still appears to be safe.

So the FDA’s decision yesterday leaving a loophole was a strange one. Even more unusual was its coordinated announcement with European drug regulators. Well, they coordinated the timing of the announcement, which was highly unusual and perhaps unprecedented. But the European Medicines Agency took Avandia totally off the market there.

The world has a controversial Cleveland Clinic cardiologist to thank. A meta-analysis led by Dr. Steven Nissen that the New England Journal of Medicinepublished three years ago exposed Avandia’s dangers to people with diabetes.

With the FDA’s action yesterday the second shoe dropped. To mix a metaphor, if you take Avandia the ball is in your court now.

Avandia (rosiglitazone), and all diabetes medications that contain rosiglitazone will be taken off the market within the next few months, says the European Medicines Agency (EMA) which has recommended taking it off the market. Specifically, the following brands are involved – Avandia, Avandamet and Avaglim. Yesterday, the FDA (Food and Drug Administration, USA) severely restricted rosiglitazone use and ordered GlaxoSmithKline, the makers and sellers of the drug, to convene an independent group of scientists to re-check data on the drug’s clinical trials.

Rosiglitazone is being currently taken by patients with diabetes Type 2 as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl).

The European Medicines Agency (EMA) says that patients who are taking these medications at the moment should see their clinician to discuss suitable alternatives. You should not stop your rosiglitazone-containing medications without first talking to your doctor, EMA stresses.

EMA has told doctors they should stop prescribing medications that contain rosiglitazone, while patients currently on such drugs should be “reviewed in a timely manner to amend their treatment.”

The CHMP (the Agency’s Agency’s Committee for Medicinal Products for Human Use) started reviewing rosiglitazone in July of this year when new study data questioning the cardiovascular safety of the medication became available.

Since being authorized in 2000, rosiglitazone has been linked to fluid retention and a higher risk of heart failure – European authorities have been monitoring rosiglitazone’s cardiovascular safety closely, EMA informs. The medication was limited in Europe to second-line treatment and contra-indicated in patients with heart failure or a history of it.

Study data that became available over the last three years have suggested a link between ischemic heart disease and rosiglitazone use, resulting in further restrictions in patients with ischemic heart disease.

In view of the already-existing restriction, plus recent study data, the Committee could not see how new measures could reduce cardiovascular risk. Committee members concluded that the benefits no longer outweigh the risks and recommended the drug be taken off the market completely.

In a press release, EMA wrote:

The suspension will remain in place unless the marketing authorization 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 now goes to the European Commission which will turn it into a legally binding decision.

Related article: “Avandia (rosiglitazone) Use To Be Severely Restricted” (About US FDA decision yesterday)

Source: European Medicines Agency (EMA)

Written by Christian Nordqvist

View drug information on Avandamet; Avandia.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Source: http://www.medicalnewstoday.com/articles/202447.php

GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions.

In the European Union*, the EMA has suspended the marketing authorization for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA have stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.

In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labeling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) program with additional measures to ensure the safe use of the medicine.

Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”

The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.

Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent reajudication of the endpoints reported in the large, prospective, randomized, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).

Financial Information

Total Avandia sales in the first half of 2010 were 321m pounds Sterling (-18%); US 164m pounds Sterling (-23%); Europe 72m pounds Sterling (-17%); Emerging Markets 37m pounds Sterling (-5%); RoW 48m pounds Sterling (-6%)**. As a result of the regulatory updates in both the US and EU, GSK now expects global sales of Avandia products to be in a range of approximately 100m pounds Sterling – 150m pounds Sterling in the second half of 2010 and with minimal annual sales thereafter. These estimates are net of customer returns of product previously sold. Associated one-off costs in 2010 comprising stock write-offs, asset write-offs and other related one-off costs are currently expected to be approximately 100m pounds Sterling on a pre-tax basis.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’ s Annual Report on Form 20-F for 2009.

Source: GlaxoSmithKline

View drug information on Avandamet; Avandia.

Source: http://www.medicalnewstoday.com/articles/202344.php