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Contraceptive® SFDA Safety Communication about Using Yasmin

2011-10-31

SFDA, represented by its Drug Sector, warned about the risk of developing Venous thromboembolism (VTE) when using contraceptives containing drospirenone, e.g.Yasmin® , the sole contraceptive registered in the Kingdom that contains this substance. The warning included the increasing risk when using this product by patients with risk factors or VTE history.

SFDA explained that the manufacturer of this drug will issue communication to all Health Care Professionals re. the risk of developing VTE when using Yasmin® product and shall update the drug insert or literature to reflect this warning.

Directions to all Health Care Professionals, to observe the following instructions:

Oral use of contraceptives containing more than one substance will increase the risk of having VTE. The risk of VTE increases with the use third generation of contraceptives containing drospirenone, progetogensm, desogestrel or gestodene compared to second generation of contraceptives. The risk also increases in patients with VTE history, aged patients or patients with risk factors

-Discus potential benefits and risks with patients before prescribing contraceptives containing drospirenone

- Encourage patients to report about the following VTE symptoms e.g. ubnormal pain, reddish or swelling legs, sudden breathing congestion or breathing difficulty or coughing without clear cause

- For further information or questions about contraceptives containing drospirenone please contact the national center for drug and toxics information on the following link:

SFDA encourages the public and Health Care Professionals to report about any side effects to the national Pharmacovigilance centre through email or free mail to the following address:

The National Pharmacovigilance Centre

Saudi Food & Drug Authority

3292 Northern Ring Road- Al Nafal Section

Riyadh 13312-6288

Kingdom of Saudi Arabia

Telephone 012038222 Extensions: 5769. 2356. 2354. 2317.5785. 2353

Fax: 012057662


 

The Authority