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FDA Finds Avandia Maker Failed To Report Required Data

Diabetes drug can increase risk of heart attack in some patients

April 8, 2008

Diabetes • Studies Find Link Between Diabetes and Alzheimer's • Avandia Maker Failed To Report Required Data • Prediabetes: What You Should Know • Study: Large-Breasted Women More Diabetes-Prone • U.S. Diet Dishes Up Diabetes • Weight-Loss Surgery Seen Beneficial to Diabetics • Lack of Deep Sleep May Increase Diabetes Risk • Study: Avandia May Do More Harm than Good • FDA Orders New Warning For Avandia • U.S. Kidney Disease on the Rise • Fish Oil May Fight Diabetes • Avandia vs. Actos: A Doctor's Advice • Avandia Linked to 42% Greater Risk of Heart Attack • Soft Drink Sweetener Linked to Diabetes in Kids • Diabetes Drugs to Get 'Black Box' Warnings • FDA Rejects Advice to Pull Avandia From Market • FDA Advised to Pull Avandia From Market • Avandia, Other Diabetes Drugs Increase Risk of Heart Failure • Dairy Products May Protect Against Metabolic Syndrome • Portion-Control Dishes May Help Obese Diabetics • FDA Issues Safety Alert on Diabetes Drug Avandia • Stem Cell Treatment May "Cure" Diabetes • Diabetes Risk May Be In The Genes • Holiday Gluttony Can Spell Disaster for Undiagnosed Diabetics • Malaria Drug May Fight Common Cause of Diabetes, Heart Disease • Feds Attack Fake Diabetes Cures • FDA Approves New Treatment for Diabetes • Feds Warn Of Counterfeit Diabetes Tests • Study: Weightlifting Helps Overweight Teens Avoid Diabetes • Researchers Say They Can Reverse Type 1 Diabetes • Study: Obesity Major Factor in Diabetes Epidemic • Too Much, Too Little Sleep Linked To Diabetes In Men • Procedure Cures Some Diabetic Mice • Ethnicity Skews Diabetes' Effect on Heart • Pig Cells May Be Useful in Diabetes Treatment • Protein Triggers Fat-Saturated Cell Death • FDA Approves Diabetes Inhaler Exubera • FDA Panel Greenlights Diabetes Inhaler • Breastfeeding May Decrease Diabetes Risk • Low-Fat Dairy Products May Lower Diabetes Risk in Men • Scientists Find Diabetes "Switch" • New Diabetes Treatment Approved • Knowledge of Diabetes Doesn't Always Affect Outcomes • Moderate Exercise Helpful to Diabetes-Prone Women • Life Expectancy Increases; Diabetes Epidemic Worsens

The U.S. Food and Drug Administration has warned British drug company GlaxoSmithKline that it failed to provide required information about its diabetes drug Avandia when the agency was considering a stronger warning. The company has confirmed it had received a letter from the FDA, spelling out its concerns.

The FDA required the firm to strengthen its warning about Avandia's heart risk last year, but the agency says it has now learned it didn't have access to all of Avandia's testing data before it approved the warning.

The letter says GlaxoSmithKline failed to list several studies, as required, dating back at least six years.

The company says the omitted information was from periodic reports to the FDA regarding Avandia, such as the start and progress of clinical trials, and summaries of final data from some clinical trials.

The FDA inspection, which uncovered the omissions, also reviewed GSK's processes for reporting individual adverse events, which resulted in no inspection citations, the company said.

"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."

After the inspection, GSK said it initiated a review of applicable processes and reporting systems. The company said it has made and will continue progress in updating its procedures and improving compliance in this area of reporting, including additional training for employees to ensure that all procedures are followed across all product lines.

Last November GSK agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

The FDA said people with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their doctor about the revised warning as they evaluate treatment options. FDA advises doctors to closely monitor patients who take Avandia for cardiovascular risks.

The following month the Journal of the American Medical Association published a study suggesting that threatment of older patients with some diabetes medications -- including Avandia -- may cause more harm than good.

At issue is the class of medications known as thiazolidinediones, which include rosiglitazone, an active ingredient in Avandia. The study found these medications had a significantly increased risk of heart attack, congestive heart failure and death in older patients, compared with the use of other hypoglycemic drugs.

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