- Nurse.com

09/29/2011 - The Food and Drug Administration has informed the public that it remains concerned, although it has not yet reached a conclusion, about the potentially higher risk of blood clots with the use of drospirenone-containing birth control pills.

The FDA has completed its review of two 2011 studies evaluating risk of blood clots for women who use drospirenone-containing birth control pills. The FDA also has continued its review of a separate FDA-funded study evaluating 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 with users of other hormonal contraceptives.

Given the conflicting nature of the findings from six published studies evaluating this risk, as well as preliminary data from the FDA-funded study, the FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December to discuss the risks and benefits, and specifically the risk of blood clots of drospirenone-containing birth control pills.

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. The FDA previously communicated preliminary information about these concerns to the public on May 31.

The FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. It will continue to communicate any new information to the public.

Studies assessing risk of blood clots have evaluated only the specific drospirenone-containing product that combines three milligrams of drospirenone with 0.03 mg of ethinyl estradiol. It is not known whether these study results apply to other drospirenone-containing products with lower doses of estrogen.

According to the FDA advisory, healthcare professionals should:

• Consider the risks and benefits of drospirenone-containing combination oral contraceptives for a specific patient in light of her risk for developing venous thromboembolism before prescribing a drospirenone-containing oral contraceptive.

• Counsel patients about current information regarding the risk of VTE with drospirenone-containing oral contraceptives compared to levonorgestrel-containing oral contraceptives.

• Keep in mind factors for increased risk of VTE in users of birth control pills — smoking, obesity and family history of VTE, in addition to other factors that contraindicate use of combination oral contraceptives.

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