Pharmacovigilance of Jatrosom N (Tranylcypromine): Preliminary Data of a Post-Authorisation Surveillance Study

Jatrosom N (tranylcypromine) is the only irreversible and non-selective MAO-inhibitor available in Germany. Jatrosom N is used in the treatment of different forms of depression, however, Jatrosom N has a prominent role in treatment-refractory depression and advantages were discussed in the management of atypical depression.

The clinical application of Jatrosom N has been limited for years because of the need for low-tyramine diet and because of concerns about drug-drug interactions, e.g. absolute contraindication of concurrent SSRIs and a relative contraindication of concurrent TCA. Limited data is available for concurrent carbamazepine and valproate. On the other hand, it is discussed that tolerability of Jatrosom N (the perception of safety by the patient or the doctor) has been improved because of changes in the perception of dietary restrictions with respect to quality of life.

47 patients (most of them with otherwise treatment-refractory depression, 33 f, 14 m, mean age 50.2 years (34 to 77)) were treated with Jatrosom N (22 monotherapy: median dose 30mg/day (10 to 80), 25 combination therapy: median dose 25mg/day (10 to 60)). Concurrent psychotropic medication was amitriptyline (n=6), doxepine (n=6), trimipramine and mianserin, antipsychotic drugs (n=8) as well as benzodiazepines, lithium, carbamazepine and L-thyroxin. Tolerability was rated as very good (n=25), good (n=19) and moderate (n=3). Increased blood pressure for a short time was reported in 4 patients (e.g. 1 hour with RR up to 174/122). Hypertensive crisis was reported in 3 patients (e.g. 2 hours with RR up to 200/120). Nifedipine 15mg and reduction of dose in 1 patient and nifedipine 5mg in another patient were found to address these adverse events, however, treatment with Jatrosom N was not stopped. The confirmed reason of hypertensive crisis was neglect of diet in 2 patients, e.g. consumption of an aged variety of cheese. The treatment effect was rated as very good (n=21), good (n=23) and moderate (n=3). Response was found after a median time of 21 days (4 to 35). Treatment with Jatrosom N was abandoned in 2 patients.

A descriptive comparison with SSRI-treatment (n=15) and only cognitive treatment (n=15) was performed in 1 centre including 15 patients with Jatrosom N. Jatrosom N was used in patients with more severe depression (p=0.005) and with more psychotropic medication prior to recent treatment (p=0.03). A difference between treatments was found only for Jatrosom N vs. cognitive treatment (p=0.023, decrease in Hamilton Depression Rating Scale, HAMD).