Safety Data

Most herbal products have not been subjected to rigorous clinical trials, and there remains a dearth of knowledge concerning how children are affected by these substances. Paediatric subjects are physiologically more vulnerable to certain adverse effects of herbs than adults. For example, some herbs such as senna and aloe are known cathartics and some herbal teas contain powerful diuretic compounds: these actions may cause dehydration and electrolyte disturbances quickly in an infant or young child. Moreover, some subpopulations are more susceptible to certain adverse effects of herbs than other children. Subjects with allergies may be at increased risk, since the allergic potential of some plants commonly used in children that could cause contact dermatitis, rhinitis, conjunctivitis and wheezing is well known. For example, chamomile can cause anaphylaxis and other herbs such as angelica and rue are capable of photosensitization [95]. Thus paediatricians must be cautious regarding the hazards of the long-term use of herbs, even if causality is sometimes uncertain and adverse events could have been caused by overdosing or contamination of the remedy rather than by the herbal ingredient itself. A publication from the WHO Monitoring Center included 8985 case reports of adverse events associated with herbal products observed in 55 countries during the period 1968-1997: about 100 of these events were referred to children up to 10 years of age and a further 100 were related to adolescents [96].

First of all, we must distinguish between neonates and children. In the first case, newborns could be exposed to herbal products both indirectly (during the period of lactation) and directly.

How herbs may affect lactation in breastfeeding women has not been fully explored. The excretion of herbs into breast milk is a concern, as many herbs have lipophilic chemicals that may concentrate in breast milk and be transferred to the newborn. During lactation, St John's wort should be used with caution due to potential side effects. Despite good scientific evidence that this herb does not affect maternal milk production or infant body weight [97], there is also evidence that St John's wort constituents cross into breast milk [98], and a few cases of colic, drowsiness or lethargy were reported [97]. A 32-year-old Chinese woman who took Dong quai for postpartum weakness developed acute hypertension, and her 3-week-old son's blood pressure increased to 115/59 [99]. During lactation, the safety of ginkgo leaf, used for memory boosting, varicose veins or cyclic oedema, is likewise unknown and should be avoided until high quality human studies are conducted [100]. A review article recommended that black cohosh should be avoided during lactation due to its potential hormonal effects [101, 102].

Relatively few case reports are available in the literature reporting side effects of herbal consumption by infants and children (Table 21.2).

A neonate hospitalized for suspected sepsis developed chemical burns following a topical treatment with vinegar, a common home remedy [103]. An early fatal colitis was observed in a 4-year-old boy following exposure to the alkaloids detected in Chelidonium majus [104]. Other case reports documented life-threatening brady-cardia and respiratory depression in three small children following unintentional

Table 21.2 Case reports of adverse drug reactions (ADRs) in infants and children taking herbal products

Reference

Herb

Subject

ADR

Korkmaz et al. [103]

Vinegar

Neonate

Burns

Koopman [104]

Chelidonium majus

4-year-old child

Fatal colitis

Horowitz et al. [105]

Jin Bu Huan

3 small children

Bradycardia, respiratory depression

Garty [106]

Garlic

6-month-old infant

Burns

Canduela et al. [107]

Garlic

6-year-old child

Necrotic ulcers

Bakerinket al. [108]

Mint tea (pennyroyal oil)

2 infants

Multiple organ failure

Ernst [5]

Asafetida gum

5-week-old infant

Methemoglobinemia

Steenkamp et al. [109]

Pyrrolizidine alkaloids

20 children

Hepatic veno-occlusive diseases

Bagheri et al. [110]

Valerian

13-year-old child

Fulminant liver failure

Parson et al. [Ill]

Eucalyptus oil

149 children

Poisoning

Darbenet al. [112]

Eucalyptus oil

6-year-old child

Systemic intoxication

overdosing of the Chinese remedy Jin Bu Huan containing large amounts of tetrahy-dropalmatine [105]. A 6-month-old infant suffered garlic burns when his father applied crushed garlic cloves to the wrists [106], while a 6-year-old child developed a necrotic ulcer on her foot after her grandmother applied crushed garlic under a bandage as a remedy for a minor sore [107]. Two cases of serious or fatal toxicity have been described in two infants who had been given 90 to 120 ml of mint tea containing pennyroyal oil for colic and minor ailments [108]. A case of methe-moglobinemia in a 5-week-old infant treated with a gum asafetida preparation has been reported [5]. In a study carried out in two hospitals in South Africa, 20 children were diagnosed with hepatic veno-occlusive diseases, and pyrrolizidine alkaloid poisoning was suggested as the cause of the problem, confirmed from the presence of these alkaloids in the urine samples of four subjects [109]. The case of a 13-year-old child with fulminant seronegative liver failure requiring transplantation has been reported [110]: the most likely cause of the liver damage was Valeriana officinalis contained in a self-administered herbal mixture. The toxicity of eucalyptus oil in young children has been well documented and was the leading cause of hospital admission for 149 childhood poisoning in Australia [111]. In addition, systemic effects of eucalyptus oil applied topically have been reported. A 6-year-old girl was topically treated with a homemade concoction containing eucalyptus oil for pruritus: the child developed symptoms of intoxication and was admitted to hospital unconscious [112].

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