Some noncardiovascular medications have the potential to affect cardiovascular function causing adverse effects that can potentially be life-threatening. The lesson learned from Vioxx was a hard one. That is why new drugs are thoroughly screened on cardiovascular safety.
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
One of the drugs most recently scrutinized is the antidiabetes drug Avandia (rosiglitazone). The US FDA recently issued a notification to healthcare professional and patients about ongoing reviews of clinical trial data. The data in question were primarily from the large, long-term RECORD trial. The US FDA expects to complete the review in the coming months and will publicly report the review results in July this year. In the meantime, the regulatory body recommends that doctors should follow closely the prescribing info, including the black boxed warning.
New senate report puts Avandia safety in spotlight again
The ongoing US FDA review is just one of Avandia’s manufacturer GlaxoSmithKline’s (GSK) problems. A new senate report accuses Avandia researchers for unethical conduct in relation to another clinical trial called Thiazolidinediones Intervention with Vitamin D EvaluationThiazolidinediones Intervention with Vitamin D Evaluation (TIDE). The TIDE study compared Avandia with the competitor drug pioglitazone. However, the report questions the safety, thus the ethical status of the trial.
This is not the first time that GSK is criticized about Avandia. In 2007, a study was published indicating cardiovascular safety issues in connection with the diabetic drug. Furthermore, some experts believe that the pharma company was aware about the safety issues but didn’t disclose it to the authorities. The company, however, denies the allegations
“The safety and effectiveness of Avandia is well characterized in the label approved by the FDA. Contrary to the assertions in the report… the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events.”
Invirase (saquinavir): Ongoing safety review of clinical trial data
Another drug scrutinized for cardiovascular safety is the antiviral agent Invirase (saquinavir). Invirase is used in combination with another antiviral drug Norvir (ritonavir) in the treatment of HIV infection. The combination therapy, however, seems to have an adverse effect on the heart. According to the US FDA:
“The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop, known as heart block.”
The US FDA is also conducting a review of clinical trial data on Invirase.
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