Desogestrel and panic attacks – a new suspected adverse drug reaction reported by patients and health care professionals on spontaneous reports

Desogestrel is known to be commonly associated with mood changes, depressed mood and decreased libido [1]. Anxiety and panic attacks have however not yet been described with desogestrel use. In this letter, we highlight the potential relationship between desogestrel and panic attacks, which has been described by mainly patients and some health care professionals in spontaneous reports [individual case safety reports (ICSRs)] from VigiBase, the WHO global database of ICSRs [2, 3]. Contraceptive drugs are commonly used worldwide. Desogestrel is a hormonal progestin used as monotherapy or in combination with ethinylestradiol. The contraceptive effect is, in contrast to traditional progestogen-only pills, achieved primarily by inhibition of ovulation [1]. A panic attack is defined as a discrete period of intense fear or discomfort, often accompanied by physical symptoms such as palpitations and trembling. Experiencing repeated, consistent panic attacks that get in the way of everyday functioning is considered a defining symptom of panic disorder [4]. In VigiBase, there are a total of 25 reports for panic attacks and disorders [MedDRA high level term (HLT)] for desogestrel used as monotherapy reported between 2003 and October 2017. These reports were identified in a signal detection screening activity focusing on reports received primarily from patients. In the case series, 19 out of 22 reports, which had mentioned the qualification of the reporter, originated from consumers or nonhealth professionals. A disproportionality measure was used to highlight potential signals, and for this particular drug and ADR (MedDRA preferred term panic attacks), 1 case of panic attacks was expected but as many as 17 were reported [5]. A subsequent search in VigiBase revealed eight additional reports for the MedDRA HLT panic attacks and disorders. In all reports, the causality was individually assessed. The well-described reports are all from Europe and concern women between 18 to 48 years (median age 30). In 17 cases, desogestrel is the only drug reported to have been used. Of the eight other reports that had additional drugs reported, only three reports suspected another drug in addition to desogestrel for the reaction. Ethinylestradiol/levonorgestrel was co-suspected and possibly contributing to the panic attack in two cases while in the third case, the co-suspected drug, lymecycline, was unlikely contributing to the reported event. Only one patient had a documented medical history of panic attacks but she had not had a panic attack for five years. Fifteen days after starting desogestrel, she experienced a panic attack. In 11 reports, it was documented that the panic attacks occurred within 2 months of starting the contraceptive drug. The median time from start of drug intake to occurrence of the panic reactions, in the reports where such information was available, was 15 days. Commonly coreported terms were anxiety (15 reports) and depression (7 reports). In 17 cases, the patients were reported to be recovering/have recovered (one with sequelae) after withdrawal of the drug and in one case psychiatric problems (not further specified) reoccurred when the drug was started again. In five cases, it was reported that the patients had not recovered from the panic attacks at the time of reporting. Eighteen reports were classified as serious among the 22 reports that had added information about the seriousness of the case. Often, the panic attacks were not recognized as adverse drug reactions (ADRs) due to desogestrel, as illustrated by these quotes from the patients: British Journal of Clinical Pharmacology Br J Clin Pharmacol (2018) 84 1858–1859 1858