Gripe water

Gripe water for Infants- Toxicological secrets & Medicolegal issues.

(Colic, Gripe, Gripe water, Herbal tea, Per-lacteal feed, Exclusive breast feeding, Battered babies, shaken baby syndrome, Sudden infant death syndrome)

Q. What is the gripe water story?
It is serendipitous that a treatment Woodward designed for malaria is today a popular treatment for colic with an enormous commercial value. Woodward borrowed the formula, a combination of dill seed oil, sodium bicarbonate and alcohol, among other substances from physicians who were using solution in the 1840s to treat babies with “fen fever,” a form of malarial illness. (Blumenthal I J R Soc Med. 2000 Apr; 93(4):172-4.)

Q. Why it was named as gripe water?
Because this water like transparent liquid relieves from spasmodic “griping” pains in infants.
Gripe is slang non-medical term for gastric or intestinal pain; colic. "seeing your tiny baby suffering with wind and gripe".

Q. How to easy recall diagnosing infantile Colic by “Rule of 3’s”?
Colic is often defined by the “rule of three”:
• crying for more than ‘3’ hours per day,
• for more than ‘3’ days per week,
• for longer than ‘3’ weeks in an infant who is well-fed and otherwise healthy.
• occur during child’s first ‘3’ months of life.
• The condition can affect up to one in ‘3’ babies.
(Abdelmoneim E M. Italian Journal of Pediatrics 2012 38:34)

Q. How the nurses & nursing mothers can easy recall the calming techniques in colic?
Rhythmic calming techniques are effective in calming colicky babies:
Mnemonic= “7 S” approach for calming infant in colic & gripe:

• S-Swaddling, S-Safe swaddling carefully avoiding overheating, covering the head, using bulky or loose blankets, and allowing the hips to be flexed.

• S-Side or S-Stomach (holding a baby on the back is the only safe position for sleep, but it is the worst position for calming a fussy baby);

• S-Shhh sound (making a strong shush sound near the baby's ear.

• S-Swinging the baby with tiny jiggly movements (no more than 1" back and forth) always S-Supporting the head and neck.

• S-Sucking (Letting the baby suckle on the breast, your clean finger or a pacifier).

• S- Soothing music

• S- Sympathetic physician, nurses & parents. Never get angry on crying infant.
(van Sleuwen BE: Swaddling: a systematic review. Pediatrics. 2007, 120 (4))

Q. Guess the recent Bollywood movie showing infant crying persistently due to colic, not relieved by any medication, but calms down on 6th S- Soothing music everytime?
“Munna Michael” movie released in 2017- starringTiger shroff. The hero while in infantile age is shown suffering with colic syndrome, shown to get calm after soothing music

Q. What is commonest ‘non-nutritive’ preparation that was administered to infants by their mothers?
In a study conducted in Puducherry in 2009, gripe water was the commonest (55%) non nutritive preparation that was administered to infants by their mothers. Herbal Gripe water for Infants are classified as pre-lacteal feeds. (Curr Paediatr Res. 2010;14:147–52)

Q. Why we should read & learn about Gripe water?
GW use continues to be a major threat to exclusive breast feeding in this geographical area. The reasons for its continued use are due to certain misconceptions that are prevalent among mothers who use them. GW use does not confer any advantage to the baby in preventing colic nor does it help in digestion, the two most common reasons quoted by mothers who use it. (Jain, Keerthi et al. J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. Why Babie’s gripe is named as “colic”?
The term “colic” derives from the Greek word kolikos or kolon (colon is part of large intestine), it is quite characteristic, a baby who has colic often cries about the same time every day, usually in the late afternoon or evening.

Q. Why emergency doctors & nurses should read & learn about colic?
Colic or excessive crying is one of the most frequent problems presented to ER by new parents. But Organic disease accounts for <5% of infants presenting with colic syndrome.( Pediatrics. 1998 Nov;102(5 Suppl E):1282-6.)

Q. How colic increases unnecessary patient load in Emergency departments in evenings & midnights?
Infantile colic is a self-limiting condition that is distributed worldwide. It is often misdiagnosed as an organic disease for which an infant is admitted to the hospital ER, most frequently in evenings & midnights.( BMC Pediatr. 2009 Feb 4;9:9.)

Q. How Nurses & nursing mothers suspect Colic?
The crying usually begins suddenly and for no clear reason. The baby may have a bowel movement or pass gas near the end of the colic episode. Colic crying is intense and often high pitched. The face may flush, and he or she is extremely difficult — if not impossible — to comfort. Posture changes like Curled up legs, clenched fists and tensed abdominal muscles are common during colic episodes.( Savino F: Focus on infantile colic. Acta Paediatrica. 2007, 96: 1259-10.)

Q. Why Babies cry?
In fact, crying is considered part of normal infant development. Noted psychologist Gwen Gustafson offers this scientific explanation: “Neonatal crying is a species-specific behavior which achieves its likely evolutionary function (infant survival) by reliably eliciting responses from caregivers. Infantile colic is one of the major challenges of parenthood faced by persistent infantile crying. (Explore (NY). 2007 Jul-Aug;3(4):417-22.)

Q. What is colic?
Colic is defined as repeated paroxysmal episodes of excessive and inconsolable crying in a newborn who is otherwise perfectly healthy. Colic is one of the common reasons parents seek medical advice during their child’s first ‘3’ months of life.

Q. How frequently and in India gripe water is used as OTC by mothers?
Gripe water became very popular in India during 1990’s by advertising tagline showing infant crying & worried mother asking grandmother for household remedy advice for suspected infant colic.
Mother asks : “बच्चा रो रहा है, क्या करें?”
Grandmother replies: “इसे वूद्वोर्ड’स का ग्राइप वाटर देदो, अभी आराम आ जाएगा, मेरी दादी कि दादी भी येही देती थी जब बच्चा रोता था”

Q. How advertisements can promote a harmful product as harmless OTC drug?
To foster a strong belief in this product, attractive advertisements including endorsements are prominently placed in the media. “Trusted by generations of mothers in India” and “Granny gave mother and mother gave me” are examples of slogans for a popular brand. These advertisements need to be curbed and we should ensure that no promotion for infant foods or drinks other than breast milk is done.( Bhangale V. OTC Marketing of Drugs. Kerala 2001)

Q. How Charles Darwin described his own baby’s distress?
The great behavioral observer Charles Darwin described his own baby’s distress in superb biological detail: “With one of my own infants, from his eighth day and for some time afterwards, I often observed that the first sign of a screaming-fit, when it could be observed coming on gradually, was a little frown, owing to the contraction of the corrugators of the brows; the capillaries of the naked head and face becoming at the same time reddened with blood. (Explore (NY). 2007 Jul-Aug;3(4):417-22.)

Q. Why infantile colic is major issue for parents but minor issue for doctors?
Infantile colic is a common cause of maternal distress and family disturbance, Sleepless nights and the inability to console a newly arrived baby cause a great deal of stress, especially among first-time parents. The cornerstone of management remains reassurance of parents regarding the benign and self-limiting nature of the illness.(Italian Journal of Pediatrics2012 38:34)

Q. What causes Colic?
The cause of infantile colic remains unclear.
It’s a diagnosis of exclusion after ruling out organic causes- colic mimics.

Q. What are Colic mimics?
Underlying organic causes of excessive crying must be considered during the evaluation. Organic causes account for less than 5 percent of infants presenting with excessive crying infantile migraine and subdural haematoma, GIT causes include constipation ,Cow’s milk protein intolerance, Gastro esophageal reflux ,Lactose intolerance, Intussusception, rectal fissure, strangulated inguinal hernia. Infections like Meningitis, Otitis media, Urinary tract infection and viral illness can also mimic colic. Trauma has to be excluded in a colicky baby namely child abuse, corneal abrasions, Foreign body in the eye, fractured bone and hair tourniquet syndrome.

Q. What is the Link between Infantile Colic and infantile Migraine?
Infantile colic is a self-limiting disorder of excessive infant crying or fussiness that peaks at 6 weeks of age and typically improves by 3 months of age. The etiology of infantile colic has yet to be definitively elucidated, but there is increasing research to support its relationship to migraine. The importance of identifying this connection is useful in reducing invasive and potentially harmful investigations and to identify age appropriate pharmacologic interventions that would be safe in this population.( Curr Pain Headache Rep. 2016 May;20(5):31.)

Q. Does colic occurs more in bottle fed infants?
The incidence of colic in breastfed and bottle-fed infants is similar with no difference.( Clifford et al. Arch Pediatr Adolesc Med. 2002, 156: 1123-1128. )

Q. How should doctor manage infantile colic?
Laboratory tests and radiological examinations are unnecessary if the infant is gaining weight normally and has a normal physical examination. Treatment is limited and drug treatment has no role in management. Probiotics are now emerging as promising agents in the treatment of infantile colic. Alternative medicine (Herbal tea, fennel, glucose and massage therapy) have not proved to be consistently helpful and some might even be dangerous.(Italian Journal of Pediatrics2012 38:34).

Q. What is the psychological explanation for infantile colic/ gripe in healthy infants?
It is a behavioural syndrome characterized by excessive paroxysmal crying, that is most likely to occur in the evenings without any identifiable cause. Additionally, the parent may not properly bond with the child because of feelings of inadequacy and anger, leading to developing behavioral problems as the child grows. Colic may be best viewed as a clinical manifestation of normal emotional development, in which an infant has diminished capacity to regulate crying duration. (Italian Journal of Pediatrics2012 38:34).

Q. What is the medicolegal importance of infantile colic/ gripe?
Colicky babies may be at an increased risk of abuse at the hands of exhausted and frustrated parents & babysitters leading to battered baby syndrome.(Italian Journal of Pediatrics2012 38:34).

Q. Does Colicky babies at higher risk for shaken baby syndrome?
Yes. The number one trigger for shaken baby syndrome is frustration with a baby’s crying.

Q. What is shaken baby syndrome(SBS)?
SBS is a form of “non-aaccidental” head injury that occurs when a baby is shaken forcibly enough to cause his brain to rebound and bounce against his skull. “This rebounding may cause bruising, swelling, and bleeding of the brain, which may lead to permanent, severe brain damage, blindness, or even death.

Q. How are colic, gripe water and shaken baby syndrome related?
Colic peaks at about six weeks, while the incidence of SBS peaks about one month after that. It’s important to note that it is not colic that causes SBS, but rather that a colicky baby is going to cry more, which in turn raises the chances that a parent or caregiver will shake him, or will administer gripe water repeatedly, till infant calms down. SBS resulting in head injury is the leading cause of death and the most common cause of long-term disability and permanent damage in physically abused infants. ( Blumenthal I. Shaken baby syndrome. Postgraduate Medical Journal 2002;78:732-735.)

Q. How Infant colic syndrome is related to maternal fantasies of aggression and infanticide?
All mothers experienced physical and psychological symptoms in response to their infant's colic. More than 90% of the mothers with a colicky infant experienced significant marital tension and disruption in their social contacts. Explicit aggressive thoughts and fantasies were revealed by 70% of the mothers while 26% admitted thoughts of infanticide during their infant's colic episodes. Active support and counseling by physicians is critical to diminish any potential for abuse and infanticide in these infants. (Levitzky et al. Clin Pediatr. 2000, 39: 395-400. )

Q. Does any behavioral therapy on infants relieve the colic?
Behavioural studies on the use of increased stimulation gave unfavourable results, whereas results from the use of decreased stimulation and contingent music were favourable.( Journal of Paediatrics and Child Health,2012. 48: 128–137.)

Q. What is the most common reason for shaking infants?
Children are usually shaken in response to prolonged inconsolable crying. In a fit of rage the child may also be thrown down. The perpetrator is generally of limited patience and experience in handling a child. Some have admitted using shaking as a technique for stopping the child crying. Such individuals are most frequently male, fathers, boyfriends, and babysitters. (Case M et al. Position paper on fatal abusive head injuries in infants. Am J Forensic Med Pathol2001;22:112–22.)

Q. How Doctors & nurses miss out shaken baby syndrome in infants brought after episode of colic?
The mildest are non-specific so that injury may never be detected; the most severe being the shocked, unconscious, convulsing child. Immediately after the incident the child will always be obviously unwell, even to the most inexperienced carer. The non-specific signs that may persist for days or weeks are poor feeding, vomiting, lethargy, and irritability. These signs are often minimized by doctors and may be attributed to viral illness, feeding problems, or colic. (Jenny et al. Analysis of missed cases of abusive head trauma. JAMA1999;281:621–6.)

Q. What are principles in emergency management of the unconscious infant when the cause is unknown?
Provide life support.
Suspect shaking injury.
Look for retinal haemorrhages and other causes.
Perform computed tomography when cause remains unknown or retinal haemorrhages seen.
Inform social services and police if subdural haemorrhage confirmed.

Q. What is the pathophysiology of shaken baby syndrome?
The sequence of events in shaken baby syndrome is initiated by violent whiplash shaking. Cervical hyperextension causes stretch injury to the neuraxis. This produces breathing difficulty or apnoea. The ensuing hypoxia and shock cause hypoxic ischaemic cerebral injury. Further brain damage occurs as a consequence of cerebral oedema, intracranial hypertension, and a fall in cerebral perfusion pressure. In comparison with traumatic injury in infancy, inflicted injury has a much worse prognosis. Subdural and retinal haemorrhage are important markers of shaking injury. The fastest, most sensitive and specific method of determining a shaking injury is diffusion weighted MRI. Where possible this should be undertaken in conjunction with the initial computed tomogram. (Blumenthal I Shaken baby syndrome Postgraduate Medical Journal 2002;78:732-735.)

Q. What is the advice for preventing harm by parents & babysitters feeling irritated with infant colic?
• If you can’t calm your baby and feel like you are about to lose control:
• Stop what you are doing immediately.
• Put your screaming baby down in a cot, swing or other safe spot.
• Walk away – to the next room, outside, anywhere that will get you away from the situation until you have regained your composure and are able to comfort your baby.
• Reach out for help. It’s important to take care of yourself, too. Even asking your partner, a friend or family member to watch your little one while you walk around the block for a little break can help.

Q. What herbal medicines are frequently used in colic as self-medication?
Herbal medicines constituted 51.8% of the self-medicated medicines, of which 26.2% were "Ororo Ogiri". Nospamin (49.5%) and Gripe water (43.0%) were the two frequently prescribed and self-medicated medicines for infants with colic.( BMC Pediatr. 2009 Feb 4;9:9.)

Q. What is the truth about Gripe water?
GW administration does not prevent excessive crying due to infantile colic. (Jain, Keerthi et al.J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. What are significant problem in babies who are administered GW?
Vomiting and constipation are significant problem in babies who are administered GW, which could also lead to unnecessary investigations like thyroid function tests and abdominal radiographs, by the treating physician. In addition more infants who received GW had also received medical attention for common ailments like cough, cold and fever. (Jain, Keerthi et al.J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. How unethical use of Gripe water can be discouraged?
Health education to all mothers about the possible harmful effects of gripe water use in infants should be initiated at the antenatal period itself so that the mothers are fully aware of safe and healthy feeding practices to be adopted in feeding their infants.( Jain, Keerthi et al.J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. How common is gripe water used in India?
Gripe water (GW) administration to young infants is common practice in this part of country. 64.18% of the mothers were administering GW for their infants. Most mothers believed that GW helps in digestion and prevents stomach ache. Infantile colic, vomiting and constipation were common in GW administered infants.( Jain, Keerthi et al. J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. Is gripe water scientifically approved for use in infants?
The use of gripe water has neither been scientifically studied nor approved by drug regulatory authorities for use in infants, yet it is freely available as over the counter product. Exclusive breast feeding is hindered by the practice of administering pre-lacteal feeds which is seen in almost 50% of babies delivered in one cross-sectional study in India. ( Jain, Keerthi et al. J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. Why Gripe water becomes problem for infant’s nutrition?
GW administration is a common problem in infants and remains a significant challenge that thwarts exclusive breast feeding. More over GW administration does not seem to prevent infantile colic and on the other hand, may be associated with vomiting and constipation. Misconceptions prevailing among mothers have to be removed by effective counseling so that the mothers are aware of safe and healthy feeding practices to be adopted for feeding their babies.

Q. How frequently mothers administer gripe water to their infants?
Most mothers administered gripe water atleast once a day. (J Clin Diagn Res. 2015 Nov; 9(11): SC06–SC08.)

Q. Why mothers all over the world, unanimously administer gripe water to their infants?
The most common reason for administering gripe water was due to the false belief that:
i) it helps in digestion – (81.86%) followed by;
ii) it prevents stomach ache – (27.90%);
iii) insistence of elders (18.13%); and
iv) it is good for health (15.34%) respectively.
(Jain K et al. Gripe Water Administration in Infants 1-6 months of Age-A Cross-sectional Study: JCDR. 2015;9(11):SC06-SC08.)

Q. How outcome of infants consuming Gripe water compared to those who did not receive it differ?
The most common reason for administering gripe water in the present study was found to be the belief that it aids digestion and it prevents stomach ache. On the contrary, we have observed that most infants who received GW, continued to cry excessively (suggestive of colic) compared to those who did not receive it. And this shows that the administration of GW may not be able to prevent excessive crying during infancy due to colic. Similarly, the number of babies who had vomiting and constipation were more in the GW group compared to “no GW” group. Hence it is clear that GW administration is a risk factor for vomiting and constipation as it contains non-proprietary medications in it, the pharmacological action of which remains to be proven. (Jain K et al: JCDR. 2015;9(11):SC06-SC08.)

Q. What is the effect of using gripe water on breastfeeding of healthy full-term infants?

We found no evidence of benefit to newborn infants and possible negative effects on the duration of breastfeeding from the brief use of additional water, gripe water or glucose water, and the quality of the evidence from a small pilot study on formula supplementation was insufficient to suggest a change in practice away from exclusive breastfeeding. (Cochrane Database Syst Rev. 2014 Nov 25;(11))

Q. Do allopathic pediatricians prescribe Herbal Gripe water for Infants?
One cannot presume that all herbal preparations are safe and free from side effects. Allopathic doctors should stop prescribing these non-allopathic medications and laws should be made stringent to prevent over the counter access of the same. In one study, it was found that 43% doctors prescribed the Herbal Gripe water for Infant colic. (Drug and Therapeutics Bulletin. Management of infantile colic. BMJ. 2013;347:f4102)

Q. What misconception of gripe water for using in babies?
A baby is more likely to experience stomach discomfort when unable to pass gas. Some babies cry for several hours over days or weeks. Since the herbs in gripe water theoretically help with digestion, this remedy is thought to help with colic caused by gassiness. Gripe water is also used for teething pain and hiccups.

Q. How does gripe water harm babies?
Anything (including gripe water) other than breast milk administered to a baby during the first six months may increase the risk of introducing bacteria, causing allergies and irritating the baby's intestines. Gripe water just like any other pre-lacteal given soon after birth may cause delay in establishment of breastfeeding and reduce breast milk supply.

Q. How does Sugar in gripe water harm babies?
The high sugar content of gripe water can harm the erupting teeth.The possibility of the soothing effect of gripe water could be due to its sweet taste. (Blumenthal I, Fenton D. A gripe about gripe water. Arch Dis Child. 1989;64:306–7)

Q. Describe fatal septic shock secondary to “gripe water” ingestion ?
Pseudomonas aeruginosa septic shock secondary to “gripe water” ingestion has been reported in a nine-month-old girl. (Sas D, Enrione MA, Schwartz RH Pediatr Infect Dis J. 2004 Feb; 23(2):176-7.)

Q. What does FDA Warns Consumers about risk from Baby's Bliss Gripe Water?
Risk of Cryptosporidium Illness. In 2007, FDA confirmed the presence of cryptosporidium after investigating the illness of a six-week-old infant in Minnesota who consumed Baby's Bliss Gripe Water, apple flavor and advised consumers to throw away bottles of the product.

Q. How does gripe water in babies causes addiction?
It has been hypothesized that the alcohol content of gripe water provides a soothing effect. In some of the other commercial gripe waters, the alcohol content has been as high as 9% making even adults to get addicted. (Levin S,S Afr Med J. 1968 Jul 27; 42(29):753-7)

Q. Does indian gripe water has alcohol?
Though previously gripe water had alcohol in its composition, this is no longer a common constituent. A net search revealed that most brands of gripe water in Indian market are alcohol free but contain sodium bicarbonate, varying combinations of herbs or dill oil.

Q. How does Sodium bicarbonate in gripe water harm babies?
Sodium bicarbonate in gripe water has no role as hyperacidity is not a cause for colic. Moreover, if given continuously and in large doses, it may cause alkalosis and milk alkali syndrome.

Q. Is gripe water baby-friendly?
Apart from soothening agents like alcohol and sugar, GW has been known to be contaminated with organisms like pseudomonas and cryptosporidium which can cause serious illness in administered infants.
(Adhisivam B. Is gripe water baby-friendly? Journal of Pharmacology & Pharmacotherapeutics. 2012;3(2):207-208. doi:10.4103/0976-500X.95544.)

Q. Gripe water: what is it? Why is it given?
Large numbers of babies are given gripe water for no valid reason or for only trivial symptoms.
(Illingworth C, Timmins J Health Visit. 1990 Nov; 63(11):378.)

Q. How many doctors prescribe gripe water? Do mothers use it for Self-medication for infants with colic ?
According to a study from Nigeria, 30% of mothers used gripe water as self-medication to treat infants with colic while 43% doctors prescribed the same. (Oshikoya et al. BMC Pediatr. 2009 Feb 4; 9():9.)

Q. How frequently and in which country gripe water is used as OTC by mothers?
It is very obvious that gripe water has crossed borders and socioeconomic strata and is being liberally used by doctors and mothers. A survey of 200 mothers in Sheffield revealed that babies were given gripe water by 64% of mothers within the first month.

Q. What are Infant feeding and child rearing methods in Pondicherry, South India?
The custom of using gripe water for infants on a routine basis and for colic is the irrational practice in India. The beliefs and customs of people have a greater impact on the child rearing practices pushing the aforementioned guidelines to the back seat. Though WHO guidelines on infant and young child feeding do exist, in reality they are often not practiced. (Puri RK, Khanna KK, Ashok Kumar G, Prasada Rao DC. Indian J Pediatr. 1976 Nov; 43(346):323-32.)

Q. What are WHO recommendations for infant’s gripe water in Baby Friendly Hospital Initiative?
WHO recommends mothers worldwide to exclusively breastfeed infants for the child's first six months to achieve optimal growth, development and health. The “Ten Steps to Successful Breastfeeding” are the foundation of the WHO/UNICEF Baby Friendly Hospital Initiative (BFHI). According to the sixth step of BFHI, newborn infants should not be given food or drink other than breast milk, unless medically indicated.( Vallenas C, Savage F. Evidence for the ten steps to successful breastfeeding. Geneva: World Health Organization/CHD/98.9; 1998. pp. 48–61.)

Q. What is the recently found toxic effects of a preservative added in gripe water?
Bronopol is found to be present in the contents of famous gripe water by Woodword’s – It contains preservatives -namely Bronopol, Sodium Methylparaben, Sodium Propylparaben, Sodium Benzoate.

Q. How Bronopol becomes neurotoxic for infants consuming gripe water frequently?
Bronopol acts by releasing FORMALDEHYDE. Bronopol, when diluted in aqueous solution, at warm temperature and/or higher pH, may release formaldehyde, which is converted into formic acid, a basal ganglia toxic compound. (Trivisano M, et al. Bilateral putaminal necrosis and bronopol toxicity. BMJ Case Rep. 2015; 2015:)

Q. What is the role of pharmacist in stocking gripe water for OTC sale?
Pharmacists should be cautious about stocking or recommending various "gripe water" products, such as woodword’s gripe water, Little Tummys Gripe Water, Baby's Bliss Gripe Water, Wellements Gripe Water, and Gentle Care Gripe Water. These unproven products contain sodium bicarbonate, ginger, fennel, and/or chamomile, none of which is known to be safe in babies or effective for colic. Pharmacists should neither stock nor recommend these products.( Sas D, Enrione M, Schwartz R. Pseudomonas aeruginosa septic shock secondary to "gripe water" ingestion. Pediatr Infect Dis J. 2004;23:176-177.)

Q. What Is Safe for Babies?
The end result of the FDA's deliberations is that many nonprescription products are prohibited in children under the age of 2 years, while others are labeled against use in patients under the ages of 3, 4, 5, 6, 12, 17, or 18 years. For example, the FDA recommends that OTC cough and cold medications not be used to treat infants and children under 2 years of age, and manufacturers have recently announced voluntary labeling changes for those under age 4. Products safe for use in babies include the following: teething products, ibuprofen concentrated infants' drops (except when used for sore throat), ipecac syrup, sunscreens (with age restrictions), and some nonmedicated topical products, such as those used for diaper rash. The pharmacist can recommend topical products for teething if the child is 4 months or older.

Q. Describe case of ingestion of topical antiseptic as slimming drink: bronopol overdose?
We describe the case of a Italian patient who presented with acute impairment of consciousness and tetraparesis after she had been drinking several bottles of a topical antiseptic solution (Lysoform Medical) containing 2-bromo-2-nitro-1,3-propandiol (bronopol) among excipients, in order to lose weight during previous months. Moreover, she had been on a strict slimming diet. A middle-aged patient presented to our neurology department because of a persistent impairment of consciousness for 3 h. She was found on the grounds of her house with difficulty in speaking. Her relatives reported she had fever and nausea, and had been vomiting for 48 h. On clinical examination, she had GCS score of 7/15. Her pupils were in reactive mydriasis. She had a tetraparesis with weak deep tendon reflexes but no evidence of sensitivity impairment or extrapyramidal signs. Significant cardiovascular system impairment with blood pressure at 80/50 mm Hg, tachycardia and cold limb extremities were found. Blood oxygen saturation was equal to 83%, with periodic breath and inspiratory accessory muscle recruitment. Soon after admission, a severe respiratory and metabolic impairment became rapidly evident, requiring an intensive care unit admission. Cerebral MRI showed the presence of bilateral putaminal necrosis. She recovered in 10 days, surprisingly, without any evident clinical neurological signs. Methanol, also bronopol, when diluted in aqueous solution, at warm temperature and/or higher pH, may release formaldehyde, which is converted into formic acid, a basal ganglia toxic compound. A cerebral CT scan showed a bilateral putaminal hypodensity. Based on the suggestive latter finding, serum methanol and ethylene glycol dosages were performed without their detection. A cerebral MRI, performed the day after the admission, confirmed the presence of a bilateral putaminal necrosis. During the 6 h following admission, the patient's respiration was increasingly impaired and she was placed on mechanical ventilation in intensive care unit (ICU). She was treated with bicarbonates followed by rehydrant therapy with resolution of the ketoacidosis within 24 h. (Trivisano M, et al. Bilateral putaminal necrosis and bronopol toxicity. BMJ Case Rep. 2015; 2015:)

Q. Describe Pain-relieving agents for infantile colic?
Dicyclomine, Cimetropium bromide relieves the spasm. Alcohol & Sucrose have soothing effect in colic. Simethicone is not found to be useful in infant colic. (Cochrane Database Syst Rev. 2016 Sep 16;9)

Q. What are herbal remedies used in infantile colic?
Herbal remedies- plant extracts- Matricaria recutita, Melissa officinalis (ie, Matricaria chamomilla [chamomile], Foeniculum vulgare [fennel], Melissa officinalis [lemon balm], and Mentha piperita [peppermint oil]) . We found low-quality evidence suggesting that herbal agents reduce the duration of crying compared with placebo. We found moderate-quality evidence indicating that herbal agents increase response over placebo.( Alves et al. Effectiveness of Mentha piperita in the treatment of infantile colic: a crossover study. Evid Based Complement Alternat Med. 2012:b981352)

Q. Why gripe water is recognised as safe alternative option compared to Dicyclomine for treatment of colic?
Since Dicyclomine hydrochloride is an anticholinergic drug that has been proven in clinical trials to be effective in the treatment of colic. However, because of serious, although rare, adverse effects (eg, apnea, breathing difficulty, seizures, syncope), its use cannot be recommended. So most pediatricians advise verbally OTC products like gripe water ( BMJ. 1998, 316: 1563-1569. )

Q. What is the role of simethicone in colic?
Simethicone-containing products as Infants' Mylicon Drops and Little Tummys Gas Relief Drops. Simethicone is nontoxic , but has placebo effect in relieving colic.(Gupta SK. Update on infantile colic and management options. Curr Opin Investig Drugs. 2007;8:921-926)

Q. What are effective medications for colic?
Cimetropium bromide, which is widely used in Italy to treat infantile colic, showed a decrease in duration of crying crises in the treated group compared with placebo. The major side effect was sleepiness; there were no reports of life-threatening events. (J Pediatr Gastroenterol Nutr. 2002, 34: 417-419.)

Q. Why Cimetropium is not recommended for OTC use for infant colic?
Cimetropium bromide is a belladonna derivative. cimeATROPium (ATROPA- belladona). It relieves colonic spasm by its antimuscarinic effect. Evidence does not support its use in infantile colic, due to undesirable side effects such as gassiness, abdominal distention, drowsiness, and — in some extreme cases — life-threatening events that may include respiratory distress and apnea. ( Hall, B et al. Journal of paediatrics and child health.2012. 48 (2): 128–37.)

Q. What can be used in formula fed infants with colic?
Casein hydrolysate formula in formula-fed infants or a low-allergen maternal diet may be useful in breastfed infants with infantile colic.( Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. J Hum Nutr Diet. 2001;14:359-363)

Q. What is the role of Probiotics in treatment of infantile colic?
Lactobacillus reuteri endogenous to the human GI tract was found to relieve colic symptoms in breastfed infants within one week of treatment. In a more recent study, 50 exclusively breastfed colicky infants were randomly assigned to receive either L reuteri or placebo daily for 21 days. A 50% reduction in crying time from baseline was noted in the L reuteri group compared with the placebo group on 7 days(Savino F et al. Pediatrics. 2007, 119 (1): e124-e130.) (Savino F et al. Pediatrics. 2010, 126 (3): e526-e533.)

Q. What is the role of Herbal Tea in treatment of infantile colic?
Herbal teas containing mixtures of chamomile, vervain, licorice, fennel, and lemon balm, used up to three times a day (150 mL per dose) have been shown to decrease crying in colicky infants. Given the multiplicity of herbal products, the lack of standardization of strength and dosage, and potential interference with normal feeding, parents should be cautioned about their use. (Weizman Z et al. J Pediatr. 1993, 122: 650-652.)

Q. What is the role of acupuncture in treatment of infantile colic?
Acupuncture in infantile colic has shown promising results in the few scientific trials conducted. Acupuncture releases different neurotransmitters and hormones, is calming, gives pain reduction and affects digestion. Some RCT studies concluded that ‘acupuncture appears to reduce crying in infants with colic safely.’ So is acupuncture the “miracle cure” for babies with colic? Based on the evidence thus far, no it is not. (Dobson et al. Manipulative therapies for infantile colic. The Cochrane Library Published Online First: 2012)

Q. What is the role of infant whole body massage with baby oil in preventing colic?
Although most grandmothers recommend & conduct regular infant body massage very frequently for preventing colic. But Evidence for the efficacy of infant whole body massage & spinal manipulation in treating infantile colic is inconclusive. Whole body massage may improve circulation & helps in increasing physical activity in dull infants, thus promoting growth. But Physicians should be cautious about recommending massage & spinal manipulations in infants for preventing colic. (Wiberg et al. J Manipulative Physiol Ther. 1999, 22 (8): 517-522. )

Q. What is take home message for parents having infant colic?
Numerous studies mentioned above have shown that when key components of the “7 S’s” (e.g. swaddling, shushing, swinging) are used all night they can improve sleep or reduce crying; and, when the “7 S’s” are done correctly and in combination, they offer significant potential to promptly reducing infant crying and promote sleep.
Remind parents about the importance of feeding a hungry baby, changing wet diapers, and comforting a baby who is cold and crying as a result of these factors. Soothing music accompanied with parental attention (including eye contact, talking, touching, rocking, walking, and playing) may be effective in some infants and is never harmful.
Encourage parents to discuss their feelings and concerns with each other to obtain support.
Emphasize the responsibility of the whole family in the care of a baby with colic. (Italian Journal of Pediatrics2012 38:34)

Q. Where is Gripe water classified under Drugs & cosmetics act, 1940?
In terms of Rule 123, drugs listed in Schedule K of the D&C Rules, 1945, do not need a licence for sale if sold by shop other than a chemist’s shop. Drugs in Schedule K include the Gripe water & other household remedies for minor ailments. It is enlisted in category of Complementary & alternative therapies.( MC Gupta. Indian Journal of Clinical Practice, Vol. 23, No. 12, May 2013)

Q. What are the Legal Aspects of Over-the-counter Sale of Gripe water & other infantile products?
The term “over-the-counter drugs (OTC drugs)” is a loose and legally undefined term. It does not find a mention in the Drugs and Cosmetics Act, 1940, or the Drugs and Cosmetics Rules, 1945. OTC drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency(FDA) to ensure that they are ingredients that are safe and effective when used without a physician’s care. ( MC Gupta. Indian Journal of Clinical Practice, Vol. 23, No. 12, May 2013)

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