Years after concerns first emerged about link between the diabetes drug Avandia and heart problems, a new study appears to add new evidence about the increased risk that users may suffer a heart attack, heart failure or other cardiac injuries.
In a study published this month in the medical journal The BMJ, Yale researchers warn that Avandia side effects increased the risk of a cardiac event by 33%.
The findings come years after tens of thousands of individuals nationwide filed Avandia lawsuits against the manufacturer of the diabetes drug, alleging that they suffered a heart attack or other injury following use of the medication, and the manufacturer has paid billions in damages, settlements and fines.
In this latest study, researchers conducted a systematic review and meta-analysis of 33 clinical trials that used individual patient level data (IPD) which involved at least 24 weeks of patient use. They looked for acute myocardial infarction (heart attacks), heart failure, heart-related deaths, and non-heart related deaths linked to the use of Avandia (rosiglitazone).
According to the findings, Avandia use had a 33% increased risk of a composite event compared to controls. The odds for a heart attack were increased 17%, the odds of heart failure were increased by 54%, cardiovascular-related death risk was increased 15% and the risk of death not associated with heart problems was increased by 18%.
The researchers noted that the risks were higher when looking at individual patient data than when using summary data.
“The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events,” the researchers concluded. “Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety.”
Some reports have suggested that as many as 100,000 heart attacks may have been caused by Avandia, and the drug’s manufacturer has reportedly paid more than $1 billion to settle Avandia heart attack lawsuits brought by former users of the medication who allege inadequate warnings were provided to consumers and the medical community.
Concerns led to the FDA adding severe restrictions on Avandia use in 2011, which were later removed in 2015 when the agency questioned whether the evidence showed actual heart risks.
In 2012, GlaxoSmithKline plead guilty to Justice Department charges that it tried to illegally market Avandia and paid fines of about $3 billion. It also paid millions to states for charges that it defrauded their health care programs by failing to provide adequate warning of Avandia heart attacks.