NPRA Banner

               
Product Search   QUEST3+ System   Enquiries   Sitemap  

Combination Products containing Cyproterone Acetate 2mg and Ethinylestradiol 0.035mg: Restriction of Indication and Measures to Reduce Risk of Thromboembolism

User Rating: 1 / 5

Star ActiveStar InactiveStar InactiveStar InactiveStar Inactive
 

Date: 14 May 2014

Description: NPCB would like to inform all healthcare professionals that a Safety Update Report [Ref: (1) dlm. BPFK/PASCA/FV/16] has been issued as above. Following a review of the benefit-risk profile of products containing the combination cyproterone acetate 2mg and ethinylestradiol 0.035mg, the indication of these products was tightened to treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, these products should only be used after topical therapy or systemic antibiotic treatment has failed. Healthcare professionals are reminded that these products should not be used for the sole purpose of contraception, but provide adequate contraceptive effect when used for the approved indications stated above. Several steps must be taken to minimise the risk of thromboembolism when prescribing these products. NPCB will continue to monitor the situation and requests all healthcare professionals to report any suspected ADR related to cyproterone acetate 2mg/ethinylestradiol 0.035mg to the National Centre for Adverse Drug Reactions Monitoring.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Monday 09 December 2024, 11:07:51.

Search

Main Menu English