FDA Still 'Concerned' About Drospirenone VTE Risk

Emma Hitt, PhD

September 26, 2011

September 26, 2011 — Although the US Food and Drug Administration (FDA) has not reached a conclusion, the agency says it remains "concerned" about the approximately 50% increased risk for venous thromboembolism (VTE) seen among women taking drospirenone-containing oral contraceptives.

In a safety review update released today, the FDA states that it has completed its review of 2 studies conducted in 2011 evaluating the risk for blood clots in users of various contraceptives. The FDA initially announced the review May 31, saying the studies suggested that there was a 2- to 3-fold greater risk for VTE in women using oral contraceptives containing drospirenone compared with those using contraceptives containing levonorgestrel. The 2 studies were originally published online April 21 in the BMJ.

Now the FDA says that findings from a separate FDA-funded study indicate an approximately 1.5-fold increase in the risk for blood clots in women who use drospirenone-containing birth control pills compared with in women using other types of hormonal contraceptives. However, the agency says its review of the FDA-funded study is ongoing.

To date, in addition to the FDA-funded study, 6 published epidemiologic studies have evaluated the risk for VTE and have shown mixed results regarding drospirenone.

Given the conflicting findings, the FDA plans to hold a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8 to discuss the risks and benefits of drospirenone-containing oral contraceptives, and in particular the risk for VTE.

Healthcare providers should inform women currently taking a drospirenone-containing birth control pill of the potential risk for blood clots, according to the FDA.

"Women who are already taking birth control pills containing drospirenone should continue taking their pills as directed unless told otherwise by their healthcare professional," the FDA notes. "The risks and benefits of drospirenone-containing birth control pill for a specific patient should be considered in light of her risk for developing blood clots," the agency adds.

Factors associated with an increased risk for VTE include smoking, being overweight (obesity), and family history of VTE. The FDA recommends that women who are older than 35 years and who smoke should not take any type of combination oral contraceptive (including those containing drospirenone) because of an increased risk for serious cardiovascular events.

The FDA has prepared a list of questions and answers that address this issue and indicate that the agency will "continue to communicate any new information to the public as it becomes available."

More information on today's announcement is available on the FDA's Web site.

To report adverse events related to drospirenone-containing oral contraceptives, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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