57CLINICAL SAFETY

No adverse event was considered probably or definitely related to ingestion of the study medication

No severe toxic events were observed and there was no evidence of gastrointestinal bleeding.

While it should be noted that this was not a placebo-controlled study, it was concluded that Traumeel® is safe and well-tolerated in healthy subjects. The authors suggest that Traumeel® should be considered as a safer alternative to NSAIDs, particularly in patients with conditions, or receiving medications, that affect normal coagulation.[Arora 2000]

Traumeel® has anti-inflammatory and analgesic effects and does not inhibit the arachidonic acid pathway of prostaglandin synthesis. Traumeel® deserves consideration as a safer alternative for patients at high risk of gastrointestinal bleeding with conventional NSAIDs. [Arora 2000]

Randomized-controlled trials In placebo-controlled trials, no adverse effects were reported with either placebo or Traumeel®.[Zell 1998, Böhmer 1992] In the active-controlled TAASS study, adverse events were mostly mild or moderate in severity, none was serious and all treatments were equally well tolerated.[González de Vega 2013] In the MOZArT study, treatment groups were similar with regard to adverse events, particularly when considering that patients taking Traumeel® and Zeel® T completed the study more often than saline-treated patients.[Lozada 2017] The serious adverse drug reaction (ADR) rate was well below the targeted 1:30,000 patient-years rate as recommended by the 2011 Consensus Guideline of the Osteoarthritis Research Society International for OA treatments being investigated in randomized clinical trials.[Strand 2011, Lozada 2017]

Tolerability Post-marketing drug surveillance has shown that tolerability of Traumeel® is good to very good.[Zenner 1992, 1994, 1997]

In 3,467 cases treated with Traumeel® injection there were only 19 reports of undesired effects in conjunction with administration of the medication: 8 cases of local reddening at the site of injection, 1 case of brief local muscle pain, 3 cases of transient irritation of the knee joint, 1 case of pain at the injection site with no further signs of local irritation, 3 cases of a heat sensation at the site of injection, 1 case of circulatory insufficiency, 1 case of general malaise and 1 case of fatigue.[Zenner 1992]

In 3,446 cases treated with Traumeel® ointment there were only 13 reports of undesired effects that were chronologically associated with topical ointment administration.[Zenner 1994] These were local skin irritation and allergic reactions to the medication evidenced by redness of the skin and/or itching. While most reactions were minor and of brief duration, 3 patients experienced more severe reactions and symptoms were relieved on cessation of treatment. Due to the use of other medicinal preparations in these patients, a causal relationship between Traumeel® and these side effects cannot be verified.