Colic treatment containing deadly nightshade under investigation

Authorities are cracking down on parents’ access to colic medications that contain a toxic ingredient linked to almost 50 babies falling ill in the past two years.

While regulators have repeatedly warned parents not to give concoctions containing belladonna to babies due to safety concerns, a number of compounding pharmacists continue to sell the potentially dangerous plant extract in mixtures to treat colic with little medical oversight.

Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, is weighing up whether to make belladonna a schedule 4 medicine, which would require a prescription from a doctor.

Ivana Crcic and her now two-year-old daughter Romana.Credit: Simon Schluter

This masthead can also reveal that another watchdog, the Australian Health Practitioner Regulation Agency (AHPRA), is examining practitioners at an interstate compounding pharmacy who have been selling colic mixture containing belladonna to parents across the country.

After filling out a short online questionnaire on this pharmacy’s website, customers can order a $40 glass bottle of colic mixture that contains belladonna, a toxic plant commonly known as deadly nightshade.

Customers do not need to speak to a pharmacist, and no information about potential side effects is published either on the pharmacy’s website or in the print-out accompanying the medicine.

“The board takes seriously any concerns about medicines compounded for which there is no clear evidence in the reputable references or there is inadequate published safety data,” a spokesman for AHPRA and the Pharmacy Board of Australia told this masthead.

“This includes the dispensing of medicines containing belladonna for infantile colic.”

The health department overseeing this pharmacy said it had written to all compounding pharmacies to discourage supply “except under suitable medical oversight” due to the risks of adverse effects.

The pharmacy did not respond to repeated requests for comment.

In Victoria, another compounding pharmacy, Willby’s, shut down in December after the Victorian Pharmacy Authority banned it from compounding colic medications to “prevent a serious risk to public health and safety”.

Willby’s pharmacy decided to shut down in December after Victoria’s pharmacy watchdog ordered it to stop compounding colic mixtures for babies.

Willby’s colic medication was linked with 45 adverse events reported to the Therapeutic Goods Administration in 2024, with the majority of these cases involving babies. Their symptoms included vomiting, a fast heart rate, drowsiness, urinary retention and sedation.

In a discussion paper released in September, the TGA said that since the beginning of 2023, there had been 49 adverse events linked to medicines containing belladonna.

In 2023, Ivana Crcic purchased colic mixture from Willby’s compounding pharmacy in Melbourne’s south-east in the hope of settling her baby girl Romana, who spent hours every day crying and writhing in pain.

But the medicine left the three-month-old more agitated than ever and projectile vomiting.

“After she violently vomited you could tell she was in a lot of pain,” Crcic recalled of her daughter’s reactions to the mixture.

“She was screaming and red in the face.”

Colic strikes fear into all new parents. It describes an otherwise healthy baby that cries and cries and cries, from a pain of no obvious explanation and with no solution. Desperate, many parents reach for alternative medicines that offer hope of a cure.

Atropa belladona is commonly known as deadly nightshade.

While many families swear by these medicines, which are easily available but not regulated for safety and quality, they have also sickened scores of babies.

In 2024, the TGA, NSW Health and Queensland Health issued public warnings after babies who consumed colic medications containing belladonna fell sick and wound up at GP clinics and hospitals.

These babies were suffering from suspected anticholinergic syndrome, a condition linked to belladonna consumption that causes red flushed skin, dry skin, dry mouth, dilated pupils, increased heart rate, urinary retention, gastrointestinal issues, raised temperature, agitation, drowsiness, floppiness, poor feeding and occasionally seizures.

‘Colic broke me’

Nitin Kapur is one of Australia’s leading paediatricians. When his first child arrived, he thought he was prepared for anything.

“I thought I could solve every problem,” the president of the RACP’s Paediatric and Child Health Division said. “Colic broke me.”

Colic is a descriptor – not a diagnosis – given to otherwise healthy infants who cry more than three hours a day, three days a week, for more than three weeks. It seems to affect about 10 per cent of all newborns, with the crying peaking between six and eight weeks of age.

The children writhe in obvious pain. The crying – and sense of helplessness – can be so overwhelming it is the No.1 risk factor for shaken baby syndrome.

Researchers are still struggling to understand the cause. The best theory doctors have is some babies are simply slightly more sensitive to stimuli than other children. “We really haven’t been able to find an organic cause; we’ve looked at lots of issues,” said Kapur.

Kapur tries to reassure his patients, showing them evidence that colicky infants grow up into normal, healthy toddlers.

“I know it’s very distressing,” he says. “This is a transient phase, your child is not sick, and no harm is being done.”

Life-threatening side effects prompt regulator action

Dr Christopher Sim had his own first-hand experience with Willby’s Colic Mix after his wife purchased it for their colicky baby.

“He seemed a bit off,” Sim said of his son’s reaction to the mixture in September 2022. “He was sedated by the medication, which was a concern.”

The doctor did some digging and was taken aback by what he discovered.

“I was shocked to find that it contained belladonna. It was never mentioned to my wife during the sales process,” he said. “I find it extremely predatory.”

He immediately stopped giving his son the medication because he was concerned about the risk of potential side effects, including seizures.

Sim also lodged a complaint with AHPRA. This prompted the watchdog to take regulatory action against two pharmacists working at the now-closed Willby’s pharmacy over concerns that they were not adequately alerting consumers to the “risk of life-threatening side effects” of their mixtures.

One pharmacist, whom the watchdog criticised for preparing the mixture in batches rather than for individual patients, was required to attend education. The other was cautioned.

“The use of belladonna for infantile colic is not evidence-based and carries significant safety risk which is not justified for a condition that is benign and self-limiting,” AHPRA said in an unpublished decision, which was sent to Sim.

Sim said that because the medication was not registered for the treatment of colic, there was no oversight from the TGA or any requirement to submit safety data.

A spokesperson for the former producer of Willby’s said while they disagreed with the Victorian Pharmacy Authority’s assessment, they respected the decision and had co-operated with all regulatory decisions.

“Willby’s was a trusted lifeline for many families, as demonstrated by the overwhelming support from parents who credit it with providing much-needed relief during challenging times,” they said.

This support was on full display in an online petition to save Willby’s, which was signed by 1364 people.

The petition called on the Victorian Pharmacy Authority to reverse its decision to ensure that parents could “alleviate their babies’ discomfort and pain”.

“This breaks my heart,” one mother wrote. “Willby’s saved my boy, he was crying every second of every day, once he started this, his crying became so much more manageable and the postpartum depression reduced dramatically.”

An ancient poison

The ripe black-cherry fruits of Atropa belladonna are one of the first things undergraduates study in medical toxicology because of their long and poisonous history.

Atropos is one of the Greek fates, ending the life of mortals by snipping their thread; Bella Donna is Italian, referring to the beautiful women who used an eyedropper of the drug for seductively dilated pupils. Several victims in Agatha Christie books meet their demise via a vial of belladonna.

An extract from the leaves of the plant was incorporated with dill and lemon juice by Australian pharmacist and herbalist Des Lardner, using “an old formula out of a pharmacopoeia”, to make Willby’s Colic Mix.

The formula worked and was safe, he told this masthead, and reports of side effects were overstated. “For a little baby who is less than 12 weeks old to tell you it is getting side effects is a little bit far-fetched.”

He blamed pharma companies who were jealous of his success, and regulators who were “over-cautious and probably read too many Agatha Christie books”, for the formula being banned from sale. “It’s a tragedy.”

Belladonna contains a range of alkaloid compounds, including atropine, that block certain receptors in the parasympathetic nervous system – the system used by the brain to slow down our heart rate.

“It removes your foot from the brake and thus allows the heart to speed up,” said Dr Slade Matthews, senior lecturer in toxicology at the University of Sydney. “This can produce life-threatening changes in heart rhythm.”

The scientific literature is replete with case studies of colicky infants treated with belladonna tinctures who end up seriously unwell. Some suffered seizures or choking, turned blue from lack of oxygen or had heart rates of up to 200 beats per minute. Others had to be resuscitated after they stopped breathing.

Some children on very high doses can end up in a coma.

Because colic mixtures are sold over the counter, parents often think they are safe and the risk of overdose is unlikely. But even small dosing errors can have big effects on very young children. “If you’re dosing a baby, you’ve got to know what you’re doing. They don’t weigh very much,” said Matthews.

Ivana Crcic gave her daughter Willby’s Colic Mix on three occasions but stopped when she realised it was causing the same adverse reaction every time.

Ivana gave her now-two-year-old daughter Romana a colic mixture containing belladonna.Credit: Simon Schluter

“The vomiting was always 10 minutes after she ingested it,” she said. “It couldn’t have been anything else.”

She purchased the mixture, which a friend had recommended, after her GP advised her that her unsettled daughter had colic.

Her daughter was eventually diagnosed with a cow’s milk protein intolerance and her colic symptoms disappeared after dairy was removed from her diet.

“Colic is a bullshit term,” Crcic said.

“It’s not an actual diagnosis … Your baby is crying for a reason, and I feel like this is almost like gaslighting parents. It’s the worst thing as a parent to see a kid suffering.”

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