Features of notified cases
Table 1 displays the general features of cases. Of 635 cases of interest, 87% relied on spontaneous reporting. Seventy-two per cent (72%) of cases were directly submitted to SEFV-H by healthcare professionals, while 2% were reported by the public, 38% by the pharmaceutical industry, and 4% came from medical literature reviews. It is of note that a single case could have different origins. Most of cases (76%) directly submitted to SEFV-H by healthcare professionals were reported from a hospital.
Seventy-two per cent (72%) of cases were serious, and the clinical outcome was fatal in 5% of cases. Fifty-six per cent (56%) of patients were females. Patients’ age range and median age were 0,25 – 96 and 59 years, respectively. Sixty-three per cent (63%) of patients were adults, and 31% were > 65 years. In the no-Covid cases, the conditions for which HCQ was most frequently used were arthropathies (34%) and lupus erythematosus (32%). In none of the notified cases, neither prophylaxis nor treatment for malaria was the HCQ indication. In 41% of cases, the daily administered HCQ dose was lacking. Of the remaining cases, in 33% medium daily doses (i. e. 400-600 mg/day) were given, low doses in 20 %, and high doses in 6%. Of high daily doses, 100% were administered to Covid patients. The median total accumulated dose was 2,800 mg, though there were significant differences between the two groups. Most of patients (43%) received a low total HCQ dose. With respect to total cumulative dosis, all the medium / high total HCQ doses were given to no-Covid patients, since these patients were treated with HCQ for longer.