FDA doubts Sanofi’s new blood thinner
  • Fri, 06/22/2012 - 2:21pm

The U.S. Food and Drug Administration questions the advantages of Sanofi’s new blood thinner to cancer patients undergoing chemotherapy.
Semuloparin is a blood thinner intended to prevent venous thromboembolism in patients with advanced forms of cancer – like pancreatic, lung and prostate cancers – as they are treated with chemotherapy. Thromboembolism, according to MedicineNet, occurs when a blood clot forms in a blood vessel, breaks free and travels to another blood vessel through the bloodstream.
Chemotherapy attempts to kill cancer cells that grow and multiply quickly, according to the same site. Sanofi insists that chemotherapy patients have a 6.5 times greater risk of developing blood clots than cancer-free patients.
But the FDA found that few people in Sanofi’s clinical trial had blood clotting problems, and 36 percent failed to complete the study treatment period of at least 3 months. In the trial, 1.2 percent of patients taking semuloparin experienced blood clotting issues, compared to 3.4 percent of patients taking the placebo.
Results also showed that major bleeding incidents occurred more frequently in cancer patients taking semuloparin than those taking the placebo. Seven patients taking semuloparin bled severely into critical areas or organs, one of which was fatal.
The FDA’s June 18, 2012, report reflected the lack of focus on blood clot prevention in high-risk cancer patients undergoing chemotherapy. The agency remarked that there are no drugs approved to prevent blood clots in cancer patients undergoing chemotherapy and that the data Sanofi provided “do not provide meaningful support for the approval” of semuloparin as a preventative treatment for chemotherapy patients with severe forms of cancer.
The FDA also stated that medical practice guidelines require that venous thromboembolism be present in cancer patients before administering blood thinners, with the exception of certain cases like hospitalized cancer patients, patients undergoing major cancer surgery and patients taking anti-cancer medications that increase the risk of blood clots.
Despite these few cases in which blood thinners should be given to cancer patients, the FDA report suggested that semuloparin may not be useful for the overall population of patients undergoing chemotherapy.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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