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News Articles >> Avandia: Meant to Help but Killed Instead
Avandia: Meant to Help but Killed Instead
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| March 30, 2008. By Lucy Campbell |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Edmonton, AB: Early in August 2006, Vivian's mother went to the hospital in Edmonton to have some cancer tests done. However, when she arrived the doctors noticed that the left side of her body was swollen. They took her vital signs and noticed her heart was racing. She was admitted to hospital that day, and on further testing the doctors discovered that her heart was enlarged as well. Over the next few days the doctors were unable to bring Vivian's mother's heart rate under control and she died.
"My mother was pronounced dead at 6:00 in the morning, August 10 from cardiac arrest, just a few days after she was admitted to hospital. She went into hospital and never came home," Vivian told Lawyers and Settlements in a recent interview. Despite their best efforts, the doctors at the hospital failed to discover what was causing Vivian's mother's heart problems. "I had gone to see the doctors the day before she died. They were trying to figure it out. "
"But Vivian's mother was taking Avandia. "My mother was put on Avandia when it first came on the market, so she was on it for about eight or ten years," Vivian said. Based on information that has come to light since her mother's death, Vivian now believes that the very drug that was meant to help her mother could have killed her.
Avandia, also sold as Avandamet, and known generically as rosiglitazone, was approved by the Federal Food and Drug Administration (FDA), in 1999 for the control of blood sugar levels in people with type 2 diabetes, the most common form of diabetes. However, in 2006, the FDA released recommendations, based on reports of macular edema and blurred vision, and swelling in the legs and feet of patients taking rosiglitazone, that patients with type 2 diabetes who are taking Avandia may need to either discontinue it or lower the dosage. And, the FDA noted that health care professionals would be made aware of this information.
In fact during the past 18 months several reports and FDA warnings have emerged regarding the increased risk for cardiac events seen in patients taking Avandia, particularly in type 2 diabetics who are already at increased risk for heart disease and related deaths.
Then, in May 2007, authors of a study published in the New England Journal of Medicine (NEJM) reported a significant increase - 43 percent--in the risk for myocardial infarction -with rosiglitazone. They also found a 64 percent increased risk for death from other cardiovascular causes in people taking the drug. These findings were based on analyses of 42 clinical trials of the drug.
This resulted in the FDA issuing the following information in May of 2007: "Recently, the manufacturer of Avandia provided the FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease."
And the FDA also stated: "Since the drug was approved, the FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006."
The FDA concluded, "Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes."
This information applied directly to Vivian Stanley's mother - but it came too late to save her. "At the time I didn't realize that she had any cardiac problems. But there is a history of heart problems in my mother's family, including a history of heart murmurs. And my brother has a congenital heart defect," Vivian said. "My mother was also on at least 13 drugs at the time she went to hospital."
The circumstances surrounding her mother's death remain very painful for Vivian and her family, so much so that she cannot bring herself to go back to the doctor to find out anything more. But given the information on Avandia, Vivian thinks she may have her answer. "The information now available makes me believe the drug had something to do with her death," she said.
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