September 27, 2011
SAFETY ALERT: FDA Provides Safety Update on Increased VTE Risk with Drospirenone-Containing Oral ContraceptivesThe FDA has notified the public that it has not yet reached a conclusion, but remains concerned about the potential increased risk of venous thromboembolism (VTE) with the use of drospirenone-containing birth control pills. A list of drospirenone-containing oral contraceptives is available at www.fda.gov/Drugs/DrugSafety/ucm273021.htm#table. The FDA has reviewed conflicting findings from six published epidemiologic studies that evaluated the risk of VTE in women using birth control pills containing drospirenone. Two studies did not report any difference in VTE risk between drospirenone-containing products and products containing levonorgestrel or other progestins. Two publications from 2009, however, reported a 1.5- to 2-fold higher VTE risk with drospirenone-containing contraceptives as compared with levonorgestrel-containing contraceptives while two articles published in 2011 reported a 2- to 3-fold greater risk of VTE.
The FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal contraceptives. Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives, consistent with the 2009 and 2011 studies.
Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, obesity, and family history of blood clots, in addition to other factors that contraindicate use of birth control pills. Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots.
For more information visit www.fda.gov/Drugs/DrugSafety/ucm273021.htm.