Update: Ukrain (celandine extract)
Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization.
In Austria, Nowicky Pharma was prohibited from importing, manufacturing and marketing Ukrain by official notice. On September 4, 2012, the Federal Office for Safety in Health Care (BASG), together with the Federal Criminal Police, seized the pharmaceutical company's ampoules, intermediates and plant drugs and levied the manufacture of the active ingredient concentrate. The seized products are now being analyzed in the OMCL of BASG/AGES Medical Market Supervision.
The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the protection of patients. In addition, a decree issued by the Federal Minister of Health also prohibits importation into Austria on a case-by-case basis and use outside of clinical trials.
According to the pharmaceutical company Nowicky Pharma, Ukrain is a semisynthetic drug made from celandine extracts (Chelidonium alkaloids) and thiotepa.
The regulatory approval of the drug Ukrain was rejected by both the German Federal Ministry of Health (BMG) and the European Commission (orphan medicinal products). The approval by the BMG was denied in particular because the efficacy, quality and safety of the drug Ukrain could not be proven.
Safety means that, when used as intended, the foreseeable risk of undesirable effects is acceptable when weighed against the efficacy or intended purpose according to the findings of medical science.
The seller of this "illegal" drug, the company Nowicky Pharma, did not have a license under pharmaceutical law to manufacture and sell (place on the market) Ukrain.
Celandine mode of action Celandine is a poppy plant and forms an orange-red milky sap containing benzylisoquinoline alkaloids and other substances such as plant acids, cinnamic acid derivatives, saponins and flavonoids. Like numerous other yellow-flowered plants, celandine has been used in folk medicine, especially for liver and gallbladder complaints. The efficacy of celandine extracts could not be proven in controlled clinical trials.
On the other hand, the high risk of severe liver side effects after internal use of celandine has been documented by a large number of case reports. Therefore, the risk-benefit ratio for celandine must be evaluated negatively, and medical use cannot be recommended. A detailed assessment report on celandine can be found on the website of the European Medicines Agency(www.ema.europa.eu, document number EMA/HMPC/369801/2009). The traditional use of fresh milk juice against warts is also not scientifically proven.
Situation in Austria The BASG has received one case report (anaphylactic reaction) in connection with the administration of Ukrain.
Further information:
Assessment report on celandine, EMA, 20.01.2012.
BASG safety information, 11/30/2011.
Further inquiries:
Federal Office for Safety in Health Care
