Drug Safety Alert: Indian Pharmacopoeia Commission reveals ADR linked to contraceptive drug Levonorgestrel

This came after a preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Levonorgestrel is a progestin found in oral and intrauterine (IUD) contraceptives and at higher doses in emergency contraceptives. Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus which results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. Levonorgestrel also induces the thickening of cervical mucus, which helps by interfering with sperm motility and passage.

Levonorgestrel is used as an emergency contraceptive to control Fertility. It is indicated for the treatment of contraception, menorrhagia, and endometrial hyperplasia during estrogen replacement therapy in women.

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Levonorgestrel can lead to Deep Vein Thrombosis.

Deep Vein Thrombosis (DVT) is a blood clot in a vein, usually in the leg. Deep Vein Thrombosis occurs when a thrombus (blood clot) develops in veins deep in the body because veins are injured or the blood flowing through them is too sluggish. The blood clots may partially or completely block blood flow through the vein. Most DVTs happen in the lower leg, thigh, or pelvis, but they also can occur in other parts of the body including arm, brain, intestines, liver, or kidney.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPI Helpline No. 1800-180-3024 (Toll-Free)."