Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Pyrrolizidine alkaloids - Impact of the public statements made by EMA and national health authorities on the pharmaceutical industry ***

Katrin Lambrecht (Abschlußjahr: 2016)

Summary
Language: English
Pyrrolizidine alkaloids are secondary plant metabolites which are hepatotoxic in animals and humans. More than 660 pyrrolizidine alkaloids in over 6000 plants have been identified, corresponding to approximately 3 % of flowering plants. The ingestion of pyrrolizidine alkaloids can result in acute or chronic liver toxicity and genotoxicity. Acute poisoning is characterised by hepatic sinusoidal obstruction syndrome (HSOS) and can lead to liver cirrhosis and liver failure. Chronic toxicity can lead to abnormalities, mainly in the liver, lung and blood vessels, such as cell enlargement (megalocytosis), liver cirrhosis and carcinomas.
Herbal medicines derived from pyrrolizidine alkaloid producing plants (e.g. Symphytum) have been regulated in the different European countries for a long time. However, it was recently detected that herbal medicinal products, herbal teas and food supplements from non-pyrrolizidine alkaloid producing plants can also contain different amounts of pyrrolizidine alkaloids. These findings are usually attributed to cross-contamination of the herbal drugs with weeds containing pyrrolizidine alkaloids.
Therefore, different national and European legislations setting limits for pyrrolizidine alkaloids in herbal medicinal products have been enacted. This work discusses the recent regulatory developments and their effects on the pharmaceutical industry, as well as the measures undertaken by growers, herbal active substance manufacturers and finished product manufacturers to reduce and prevent the contamination of herbal medicinal products with pyrrolizidine alkaloid producing weeds.
Pages: 49