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Avandia News
EMEA Statement On Recent Publication On Cardiac Safety Of Rosiglitazone (Avandia, Avandamet, Avaglim), Europe
Main Category: Diabetes News
24 May 2007 - An article published in the New England Journal of Medicine (NEJM) has raised concern about a small increased risk of myocardial infarction and cardiovascular death in patients with type 2 diabetes treated with rosiglitazone. The article, based on an analysis of data retrieved from 42 clinical studies, showed a small increased risk for myocardial infarction and cardiovascular death among approximately 15,500 patients treated with rosiglitazone. However, death from all causes was not significantly increased.
When rosiglitazone was first authorised in the EU in 2000, it was contraindicated in patients with a history of cardiac failure. Since then, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has kept rosiglitazone under close surveillance for cardiovascular effects (cardiac failure and other cardiac disorders including myocardial infarction). The majority of the studies included in the NEJM paper have already been assessed by the CHMP. The EU product information was updated in September 2006 with information about the risk of cardiac ischaemic events.
Some of the studies in the NEJM paper included patients who were not treated in line with the indication approved in the EU. Prescribers are reminded to adhere to the restrictions for use in patients with cardiac disease as set out in the product information.
Patients are advised not to stop treatment with rosiglitazone and to discuss the medication with their doctor at their next regular visit.
1. The article 'Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes' (10.1056/NEJMoa072761) was published on the NEJM website (www.nejm.org) on 21 May 2007. 2. The rosiglitazone-containing products Avandia (rosiglitazone
maleate) Tablets, Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets, and Avaglim (rosiglitazone maleate and glimepiride) Tablets are centrally authorised products and indicated for treatment of type 2 diabetes mellitus as monotherapy or in combination with other oral antidiabetic drugs. Avandia was first authorised in the EU in July 2000; Avandamet in October 2003; Avaglim in June 2006.
3. The European Public Assessment Reports including the up-to-date product information are available on the EMEA website as follows:
-- Avandia
-- Avandamet
-- Avaglim
4. This press release, together with other information about the work of the EMEA, may be found on the EMEA website: http://www.emea.europa.eu
Avandia to Be Discussed
Lulwa Shalhoub, Arab News
JEDDAH, 10 August 2007 — The Saudi Ministry of Health is to discuss the results of studies on Avandia, an anti-diabetes medicine also known as rosiglitazone, next week to see whether the medicine is safe for use. The meeting follows reports in the Jordanian media on Monday that a study in Jordan proved that the medicine could cause users to suffer heart attacks. However, the Saudi Ministry of Health said that the issue is under investigation and that the medicine has not been banned in any country.
“The study was small and results were published in a health magazine and not by an official organization. The Food and Drug Administration (FDA) said the medicine is under watch and has not yet been pulled off the market. The Saudi Ministry of Health has also not issued anything about it,” said Dr. Ali Al-Zawawi, general director of the General Administration for Medical Licensing at the Ministry of Health.
According to the Jordanian study, 13 children out of 200 diabetes patients that were given the medicine suffered health problems.
“It’s not a big study involving 100,000 people,” said Al-Zawawi.
The general director also advised diabetic patients with cardiovascular problems to check with their doctors before using the medicine. “Patients with heart problems have to check with their doctors if they think the medicine is having an affect on their heart problem,” he said.
Saudi pharmacies only provide Avandia on prescription.
PEOPLE'S PHARMACY: Learning lessons from drug disasters
August 23, 2007 - Americans are justifiably bewildered. On the one hand, they are told to “take your medicine — it’s necessary to maintain good health.” On the other, they read that many of their medicines may cause the very problems they are trying to prevent. Some drugs may trigger troubles they never even imagined.
The asthma drug salmeterol (found in Advair and Serevent) is supposed to improve lung function for people with this serious breathing problem. But in recent years, physicians have been warned not to use this drug as initial treatment for asthma. It may increase the risk of serious asthma attacks and asthma-related deaths.
Pain relievers like ibuprofen and diclofenac may raise blood pressure and increase the risk for heart attack or stroke. Some data even suggest that such nonsteroidal anti-
inflammatory drugs are not very effective over the long term against osteoarthritis of the knee. NSAIDs might even accelerate joint degeneration.
After years of foot-dragging, the Food and Drug Administration now warns that antidepressants might prompt suicidal thoughts in some vulnerable patients.
Heartburn drugs that suppress acid such as Aciphex, Nexium, Prevacid and Prilosec have become incredibly popular. But recent reports have linked long-term use of these drugs to an increased risk of hip fractures (Journal of the American Medical Association, Dec. 27, 2006) and pneumonia (Archives of Internal Medicine, May 14).
The most recent example of a confusing drug dilemma involves the diabetes medicine Avandia. On July 30, the FDA convened a panel of experts to make sense out of the murky data surrounding this popular medication. Diabetes doctors and drug experts determined that Avandia increases the risk of heart attacks. This medicine also carries a clear risk for heart failure.
One FDA safety officer, David Graham, M.D., encouraged the agency to take the drug off the market. According to his calculations, more than 200,000 people might have suffered heart attacks or strokes from this medicine. He estimated that for every month it remains on the market, as many as 2,200 patients may suffer a serious cardiovascular complication.
Nevertheless, the assembled experts recommended that Avandia stay on the market. They encouraged the FDA to strengthen the warning on the label, however.
This mixed message leaves physicians and patients in a quandary. On the one hand, diabetes drugs are supposed to prevent the complications of diabetes. That means lowering the risk for heart problems. Taking a drug that might increase this risk seems counterintuitive.
Doctors may wonder why patients have become skeptical about new drug breakthroughs. The Vioxx and Avandia spectacles have made some people question whether they are guinea pigs in huge drug experiments.
New drugs are usually promoted aggressively. Sometimes older medications are safer solutions. There are many ways to treat arthritis, depression, diabetes, heartburn and high cholesterol. Surprisingly, even inexpensive home remedies are sometimes helpful.
Write to Joe and Teresa Graedon in care of King Features Syndicate, 888 Seventh Ave., New York, NY 10019, or e-mail them at pharmacy@mindspring.com or via their Web site: www.peoplespharmacy.org.
Rules for new drug development need a serious overhaul
* Paula J. Caplan and Emily H. Cohen
* Magazine issue 2616
11 August 2007 - TO AN American public weary of being told that the drugs they are taking are dangerous, the recent controversy over the diabetes drug Avandia will have come as little surprise. Health experts want the medicine withdrawn after various studies suggested it increased the risk of heart failure and other illnesses.
Last week a Food and Drug Administration (FDA) committee voted to keep Avandia on the market, though it demanded stronger warnings on the label (New Scientist, 4 August, p 7). This is hardly reassuring, especially since there is considerable disagreement within the FDA over the significance of the safety concerns.
This is the latest in a string of drug safety controversies in the US. Why do they keep happening? Congress voted last month to give the FDA more powers and funding to police drugs that are already on the market, but this is just a sticking-plaster
http://www.newscientist.com/subscribe.ns?prom
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