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Better Ways Needed to Track Drug Safety: Report
Posted 1 May 2012 by Drugs.com
TUESDAY, May 1 – A management plan to gather, assess and respond to data about all medications' risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday. The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted. A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor. Report recommendations include: The risk- and benefit-assessment and management plan for each drug should be a ... Read more
Related support groups: Crestor, Avandia, Rosuvastatin, Vioxx, Rosiglitazone, Rofecoxib
Two-Drug Therapy Helped Kids With Type 2 Diabetes
Posted 29 Apr 2012 by Drugs.com
SUNDAY, April 29 – Children with type 2 diabetes may achieve better blood sugar control with a combination of two drugs, metformin and Avandia, than with metformin alone, a new study suggests. However, Avandia (rosiglitazone) was recently linked to an increased risk of heart attack and stroke, so it may not be the best drug for these young patients, experts say. "Many kids with type 2 have a rapidly progressive disease requiring early onset of insulin therapy, and current approaches to oral therapy may be inadequate," said lead researcher Dr. Philip Zeitler, a professor of medicine at the University of Colorado, Denver. Zeitler noted that the choice of Avandia as a companion medication was made in 2002, before the cardiac problems with the drug were known. "Given the problems with rosiglitazone, we are not recommending it at this time," he said. "However, no problems with rosiglitazone ... Read more
Related support groups: Diabetes, Type 2, Metformin, Glucophage, Avandia, Glucophage XR, Glumetza, Fortamet, Riomet, Rosiglitazone
Four Common Meds Send Thousands of Seniors to Hospital: CDC
Posted 23 Nov 2011 by Drugs.com
WEDNESDAY, Nov. 23 – An estimated 100,000 older Americans are hospitalized for adverse drug reactions yearly, and most of those emergencies stem from four common medications, a new study finds. The four types of medication – two for diabetes and two blood-thinning agents – account for two-thirds of those drug-related emergency hospitalizations. "Of the thousands of medications available to older patients, a small group of blood thinners and diabetes medications caused a high proportion of emergency hospitalizations for adverse drug events among elderly Americans," said lead study author Dr. Daniel Budnitz, director of the U.S. Centers for Disease Control and Prevention's medication safety program. Medications previously designated "high-risk" were implicated in only 1.2 percent of hospitalizations, the study found. Working with a nationally representative database, CDC researchers ... Read more
Related support groups: Metformin, Aspirin, Coumadin, Plavix, Warfarin, Insulin, Lantus, Januvia, Glucophage, Actos, Glyburide, Glipizide, Humalog, Janumet, Novolog
FDA Medwatch Alert: Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
Posted 4 Nov 2011 by Drugs.com
includes Avandia, Avandamet, and Avandaryl [UPDATED 11/04/2011] Healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities after November 18, 2011. [UPDATED 05/18/2011] FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs. FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone ... Read more
Related support groups: Avandia, Avandamet, Metformin/Rosiglitazone, Avandaryl, Glimepiride/Rosiglitazone, Rosiglitazone
FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves
Posted 19 May 2011 by Drugs.com
THURSDAY, May 19 – The U.S. Food and Drug Administration has announced that the controversial diabetes drug Avandia will no longer be sold at retail pharmacies beginning this November, due to the cardiovascular risks it poses to patients. According to the new rules, which will go into effect on Nov. 18, the medication will only be available to patients who've been safely using the drug, those who have had no success in controlling their blood sugar with other diabetes medications or patients who have been informed of the risks and still choose to take Avandia (rosiglitazone). These patients must be enrolled in a special program to qualify to receive the drug, according to the FDA. "Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program," the agency ... Read more
Related support groups: Avandia, Avandamet, Metformin/Rosiglitazone, Avandaryl, Glimepiride/Rosiglitazone, Rosiglitazone
FDA Medwatch Alert: Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
Posted 18 May 2011 by Drugs.com
includes Avandia, Avandamet, and Avandaryl [UPDATED 05/18/2011] FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs. FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products. [UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This i ... Read more
Related support groups: Avandia, Avandamet, Metformin/Rosiglitazone, Avandaryl, Glimepiride/Rosiglitazone, Rosiglitazone
Analysis Confirms Avandia May Harm the Heart
Posted 17 Mar 2011 by Drugs.com
THURSDAY, March 17 – A new analysis confirms that those who take the diabetes drug Avandia are more likely to develop heart problems and die than those who take a similar type of diabetes medication. "The effect on public health may be considerable," the analysis authors wrote. Avandia (rosiglitazone) helps control blood sugar levels in the body, and is prescribed for patients with type 2 diabetes. Studies in recent years have differed about whether it boosts the risk of heart disease and death. In response to growing concerns over the drug's cardiovascular effects, U.S. health officials in September restricted the use of Avandia to patients with type 2 diabetes who cannot control their disease on other medications. In the new analysis, researchers looked at the results of 16 studies that involved 810,000 users of Avandia or Actos (pioglitazone), a similar diabetes medication. The ... Read more
Related support groups: Avandia
Despite FDA Warning, Avandia Use Varies Across U.S.
Posted 18 Nov 2010 by Drugs.com
WEDNESDAY, Nov. 17 – Using the controversial diabetes drug Avandia as an example, new research finds that doctors' prescribing patterns vary across the country in response to warnings about medications from the U.S. Food and Drug Administration. The result is that patients may be exposed to different levels of risk depending on where they live, the researchers said. "We were looking at the impact black-box warnings for drugs have at a national level, and, more specifically, at a geographical level, and how these warnings are incorporated into practice," said study lead researcher Nilay D. Shah, an assistant professor of health services research at the Mayo Clinic in Rochester, Minn. In 2007, the FDA required that Avandia come with a "black-box warning" – the strongest warning possible – alerting consumers that the drug was associated with an increased risk of heart attack. Before the ... Read more
Related support groups: Avandia
Diabetes Drugs Might Lower Risk of Lung Cancer
Posted 3 Nov 2010 by Drugs.com
TUESDAY, Nov. 2 – Researchers report that drugs used to treat diabetes may indeed both prevent and contain lung cancer. The findings, being presented Tuesday at the annual meeting of the American College of Chest Physicians in Vancouver, back up preliminary data that some diabetes medications might protect against tobacco-induced lung cancer. "Patients who did not develop lung cancer had a much higher chance of taking one of these medications than those who did develop lung cancer," said study author Dr. Peter Mazzone. "And those who did develop lung cancer were much less likely to have seen that cancer spread outside the chest and more likely to survive longer with one of these drugs." Both metformin and the class of drugs known as thiazolidinediones (which includes Avandia and Actos) are used by tens of millions of Americans. A mouse study published in September found that metformin ... Read more
Related support groups: Metformin, Glucophage, Actos, Janumet, Lung Cancer, Avandia, Pioglitazone, Glucophage XR, ActoPlus Met, Avandamet, Glumetza, Metformin/Pioglitazone, Riomet, Glucovance, Glipizide/Metformin
FDA Restricts Access to Avandia
Posted 23 Sep 2010 by Drugs.com
THURSDAY, Sept. 23 – In response to major concerns about heart risks, U.S. health officials on Thursday severely restricted use of the diabetes drug rosiglitazone (Avandia) to patients with type 2 diabetes who cannot control their disease on other medications. U.S. Food and Drug Administration officials also ordered the drug's manufacturer, GlaxoSmithKline, to get an independent review of a key company-run trial of the drug's heart effects. And they pulled the plug on another company-run trial comparing Avandia to its competitor, Actos. "The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," FDA Commissioner Dr. Margaret A. Hamburg said in a prepared statement. "We are seeking to strike the right balance to support clinical care." The FDA's actions followed a recommendation in the summer from its advisory panel, which, in a complex ... Read more
Related support groups: Avandia
UK Drug Regulators Want Avandia Pulled From Market
Posted 7 Sep 2010 by Drugs.com
From Canadian Press DataFile (September 6, 2010) LONDON – GlaxoSmithKline’s controversial diabetes pill Avandia should be pulled from the U.K. market because of concerns that the drug can increase the risk of heart attacks, British drug regulators said Monday. The Medicines and Healthcare products Regulatory Agency (MHRA) said an independent panel of experts had advised it that the risks of Avandia outweigh its benefits, and that the drug should no longer be sold in Britain. The body said it had sent a letter to doctors in July advising them to consider alternative treatments. The British Medical Journal also called for the immediate withdrawal of the drug, saying it should never have been licensed in the first place. Avandia was approved by the European Medicines Agency in 2000 to help lower blood sugar levels in patients with type 2 diabetes. The drug is currently under review in E ... Read more
Related support groups: Avandia
Heart Risks the Same With 2 Diabetes Drugs: Study
Posted 25 Aug 2010 by Drugs.com
TUESDAY, Aug. 24 – A new study finds that the risk of heart attacks or death after taking the glucose-lowering diabetes drugs Avandia and Actos are about the same. This is a direct contradiction to numerous other studies that found that the risk was elevated for Avandia (rosiglitazone) but not for Actos (pioglitazone). The findings are, however, in line with some other previous studies, further muddying the picture for patients and doctors trying to select the best drug with the least side effects. "The rosiglitazone story gets more and more interesting and confusing. It seems every time we have a study that indicates a problem with the drug, another one finds no trouble with it," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City. In July, members of a U.S. Food and Drug Administration advisory panel recommended ... Read more
Related support groups: Actos, Avandia, Pioglitazone, Rosiglitazone
New Data Supports Link Between Diabetes Drugs, Fractures
Posted 29 Jul 2010 by Drugs.com
THURSDAY, July 29 – New research finds that two widely prescribed diabetes drugs may raise the risk of broken bones in postmenopausal women with type 2 diabetes. There was also a fracture risk seen among men who had been prescribed either Avandia or Actos plus a loop diuretic. This isn't the first time such an association has been seen, raising doubts as to whether these drugs, which belong to the class of medications known as thiazolidinediones (TZDs), should be the first choice for treating type 2 diabetes. "This raises the question of whether this class of drugs is best for patients. There are a lot of other great drugs you can use in diabetes, the best of which is to give patients insulin, which has no real side effects and has been used for 80 years," observed Steve Hammes, chief of endocrinology at the University of Rochester Medical Center. "It's more and more clear that, as a ... Read more
Related support groups: Actos, Avandia, Pioglitazone, Rezulin, Rosiglitazone, Troglitazone
FDA Puts Partial Hold on Avandia Safety Study
Posted 21 Jul 2010 by Drugs.com
WEDNESDAY, July 21 – No new patients will be permitted to enroll in a safety study of the controversial diabetes drug Avandia until further notice, the U.S. Food and Drug Administration announced Wednesday. But under the partial clinical trial hold, those patients already enrolled in the TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) trial will be allowed to continue to participate, the agency said in a news release. An FDA advisory panel last week ruled that Avandia (rosiglitazone) does boost users' heart risks, but it also decided that the drug should stay on the market because there's no definitive evidence of an increased risk. The FDA said Wednesday that it is evaluating available data on Avandia's safety and the discussions from last week's advisory panel meeting. When the review is complete, the agency will inform the public about the findings and what they mean ... Read more
Related support groups: Avandia
Type 2 Diabetes Drug May Increase Fracture Risk
Posted 16 Jul 2010 by Drugs.com
MONDAY, Sept. 28 – Patients who take the diabetes drugs known as thiazolidinediones may be at higher risk of bone fracture, new research suggests. In the study, Dr. Ian Douglas of the London School of Hygiene and Tropical Medicine and colleagues searched a database of more than 6 million patients in the United Kingdom and found 1,819 people aged 40 and older who had had a bone fracture and had been prescribed a type of thiazolidinedione. The drugs were introduced in the 1990s and are used to treat type 2 diabetes. After adjusting their figures to account for the fact that older people are more likely to break bones, the researchers found that those taking thiazolidinediones had almost 1.5 times as many fractures while taking the drugs as they did when they weren't taking the drugs. The risk grew the longer the people took the medications. The findings support previous research that has ... Read more
Related support groups: Diabetes, Type 2, Actos, Avandia, Pioglitazone, Rezulin, Troglitazone, Rosiglitazone