A number of children’s medicines have been recalled by their manufacturer for having unsafe levels of a potentially dangerous ingredient.
Raritan Pharmaceuticals recalled three homeopathic remedies distributed through CVS pharmacy due to incorrect amounts of an ingredient in the batches. The medicines include CVS branded infant teething tablets, CVS homeopathic ear relief liquid, and Kids Relief brand homeopathic ear relief oral liquid.
Raritan initiated the recall notice when they discovered higher than specified amounts of the the ingredient belladonna.
Belladonna has long been used in homeopathic and pharmaceutical products, however it is extremely toxic in large amounts.
According to Wikipedia, Atropa belladonna, commonly known as belladonna or deadly nightshade, is a perennial herbaceous plant in the Nightshade family (which includes tomatoes, potatoes, eggplant, etc.) Solanaceae, native to Europe, North Africa, and Western Asia. Its distribution extends from Great Britain in the west to western Ukraine and the Iranian province of Gilan in the east. It is also naturalised and/or introduced in some parts of Canada and the United States. The foliage and berries are extremely toxic, containing tropane alkaloids. These toxins include atropine, scopolamine and hyoscyamine, which cause a bizarre delirium and hallucinations, and are also used as pharmaceutical anticholinergics.
Atropa belladonna has unpredictable effects. The antidote for belladonna poisoning is physostigmine or pilocarpine, the same as for atropine. It has a long history of use as a medicine, cosmetic, and poison. Before the Middle Ages, it was used as an anesthetic for surgery; the ancient Romans used it as a poison (the wife of Emperor Augustus and the wife of Claudius both were rumored to have used it for murder); and, predating this, it was used to make poison-tipped arrows. The genus name Atropa comes from Atropos, one of the three Fates in Greek mythology, and the name “bella donna” is derived from Italian and means “beautiful woman” because the herb was used in eye-drops by women to dilate the pupils of the eyes to make them appear seductive.
Belladonna is one of the most toxic plants found in the Eastern Hemisphere. All parts of the plant contain tropane alkaloids.Roots have up to 1.3%, leaves 1.2%, stalks 0.65%, flowers 0.6%, ripe berries 0.7%, and seeds 0.4% tropane alkaloids; leaves reach maximal alkaloid content when the plant is budding and flowering, roots are most poisonous in the end of the plant’s vegetation period.Belladonna nectar is transformed by bees into honey that also contains tropane alkaloids.The berries pose the greatest danger to children because they look attractive and have a somewhat sweet taste.The root of the plant is generally the most toxic part, though this can vary from one specimen to another. Belladonna leaves and berries are gathered when the the berries are almost ripe and alkaloid content is greatest which makes them suited for medicinal use.
The leaves and berries are then dried in a dark and dry place and stored airtight. Fresh belladonna berries are mashed, fermented, and distilled into alcohol. Belladonna dosage depends on the user’s age and health condition. Consumption of one or two fresh belladonna berries mildly affects perception in adults. This effect outsets in one or two hours after the berries have been ingested. Three to four fresh berries act as a psychoactive aphrodisiac, and three to ten berries are a hallucinogenic dose. The lethal dose for adults is ten to twenty berries, depending on the physiological constitution of the consumer. Consumption of two or three berries by children can be lethal.
These data notwithstanding, consumption of belladonna should be mindful and generally avoided due to the devastating toxic states that can for some individuals prove lethal even with the minimal dosage.
Despite its dangerous characteristics, in controlled settings, belladonna does have many pharmacological uses.
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