CURRENT ADR NETWORK REPORT

SEVERE NOSEBLEED IN PATIENTS TREATED WITH SINUPRET

Since SINUPRET EXTRACT (a t 2012; 43: 91-2) was introduced onto the market in 2012, reports of severe nosebleed linked to the non-prescription SINUPRET preparations, which contain ingredients from five plants, have increased. The Drug Commission of German Pharmacists (AMK) overviews a total of 18 corresponding reports from between 2000 and 2017 linked to the preparations, which are mainly offered for sinusitis or to break down mucus in patients with rhinitis - 5 related to SINUPRET FORTE and 13 related to SINUPRET EXTRACT. The bleeding was reported to predominantly start on the first day of using the preparation and last for a median of 24 hours and a maximum of 72 hours with interruptions in some cases. In 16 cases patients discontinued the preparation as a result of the nosebleeds, resulting in stopping of the bleeding (1).

According to the AMK, the nosebleed could also be caused by the treated underlying disease such as sinusitis. The close chronological connection indicates a causality as an undesirable effect of SINUPRET. In half of the reports, SINUPRET was also the only medication reported. In the remainder of the cases, the concomitant medications were essential oils, non-steroidal anti-inflammatory drugs, antihypertensive drugs, low-dose acetylsalicylic acid (ASPIRIN, generics) and metamizole (NOVALGIN, generics) among others (1).

Especially patients taking concomitant medication that increases the risk of bleeding and those with arterial hypertension should be informed of the possible risk of nosebleed. If these occur, SINUPRET should be discontinued (1). The summaries of product characteristics (SPCs) (2) do not mention nosebleed as an undesirable effect, nor are there any references to this in clinical trials (1). In light of the reports of suspected adverse effects, including severe hypersensitivity reactions (a-t 2012; 43: 22-3 and others), and the insufficient evidence of the benefits, we do not see an application niche for SINUPRET, -Ed.

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