Safety alert: Levonorgestrel-Releasing Intrauterine Device and Panic Attacks

A safety signal raised for Levonorgestrel-Releasing Intrauterine Device. There are 602 reports for the MedDRA preferred term ‘panic attack’ associated with LNG-IUDs in VigiBase. Sixty-two percent of the cases were considered as serious.

Levonorgestrel is a hormonal contraceptive progestin drug used in gynaecology for different indications. It can be used as a single substance or as the progestogen component in oral contraceptives and hormonal replacement therapy.

Levonorgestrel as single substance is the active ingredient in emergency birth control pills, intrauterine devices, and birth control implants. LNG-IUD are used by fertile women to prevent pregnancy, to reduce bleeding in idiopathic menorrhagia, and in combination with oestrogens for hormonal replacement therapy.

A panic attack is the abrupt onset of intense fear or discomfort that reaches a peak within minutes and includes at least four of the following symptoms: Palpitations, pounding heart, or accelerated heart rate. Sweating. Trembling or shaking, shortness of breath.

Panic attack is not listed as an ADR in the EU and US patient information leaflet for LNG-IUD while some other psychiatric events are, such as depressed mood, depression, and nervousness. Even though LNG-IUD has mainly local progestogenic effects in the uterine cavity, this suggests that the substance might cross the blood- brain barrier in small concentrations and hence potentially be able to cause panic attacks.

There were no clinical, pre- and post-marketing studies have established a causal relation between LNG-IUDs and panic attacks this does not exclude the possibility that individual women in rare cases may be more sensitive or predisposed to the reaction. The collected information in these spontaneous reports support a relationship between LNG-IUDs and panic attacks and that patients and prescribers may need to be made aware of the association.