To our valued community and customers,
We’re posting this as we feel it’s important for us to take a stand to uphold the integrity of what we do at Willby’s.
Over the last few months, our business has been subjected to online harassment and unfounded claims by a medical practitioner who, as a customer of ours, felt that we could have done more to disclose the ingredients within the products. We took this valuable feedback from this individual on board and have made some changes to our processes internally to ensure the ingredients and potential side effects are made even clearer to all our customers, beyond the standard practice with any pharmaceutical product.
However, this feedback progressed into an ongoing and fully-fledged attack on the efficacy and safety of our product with targeted criticism of the way we operate and our ingredients. At Willby’s, we are a family-owned business that has been offering our colic support and solutions for over 30 years with the purpose to help families be families, by helping to address the symptoms of colic, wind and reflux. We want to reassure you that the safety and integrity of the medications we produce is at the core of what we do. Our solutions are made by our team of pharmacists with decades of experience between them, and all our ingredients are listed under the Australian Register of Therapeutic Goods for use in compounded medications. In addition, our industry is tightly regulated by a strict government body who ensures standards are being met, and we are subject to these regulations.
We are recommended and referred by some of the country’s leading paediatricians for this reason.
Our use of Belladonna Tincture as an ingredient
A key criticism of this particular individual in their online posts has been our use of Belladonna Tincture as an ingredient. For context, Belladonna is a herb that has been used in medicine for centuries as a pain reliever, muscle relaxant and anti-inflammatory.
There is also a difference between belladonna and belladonna tincture. This difference means that it’s really important to distinguish between Belladonna as a total ingredient, and Belladonna Tincture (what we use).
Belladonna Tincture, versus Belladonna, is made from the leaves of the Belladonna plant and not the berries, which means the active ingredient is very mild in concentration, and the exact concentration of the active is known. We carry out chemical analysis on our product to ensure the concentration of a batch is consistent and correct. More importantly, the Belladonna Tincture we use is imported from a source which complies with a British Pharmacopeial (BP) grade and operates as a GMP/cGMP manufacturing site. This gives us full confidence in the quality and regulation of the ingredient we are sourcing.
Belladonna Tincture is classified as Schedule 2 in the SUSMP (Standard for the uniform Scheduling of Medicines and Poisons) which is also known as the Poison’s Standard produced by the TGA (Therapeutic Goods Administration). In the quantities we use, it is considered an S2 medication — this means it does not require a prescription but can only be sold from a pharmacy.
The instances that are well-documented online where Belladonna (not Belladonna Tincture) is linked to negative side effects are where the ingredient has been used in an unregulated, highly concentrated form, and easily purchased over the counter and given at doses undetermined by health professionals. Most of these instances have occurred in the US where belladonna is not regulated or approved for use in compounded preparations unlike Australia.
The medical practitioner has made mention of an account of a single adverse reaction 10 years ago on the TGA register which has not been directly attributable to the use of Willby’s and specifically, the use of the ingredient sodium citrate. Willby’s pharmacists take scrupulous care in determining if any baby has an underlying medical issue where the use of Willby’s is contraindicated.
Willbys mix and its ingredients are listed in every poisons register in every state in Australia and we comply with all standards and requirements. We keep an accountable adverse reaction register that is available for scrutiny by all regulatory bodies.
Potential side effects and contraindications
If you’ve ever purchased medication before, you’ll most likely be aware that almost all medications come accompanied by unwanted potential side effects but not everyone will experience them. For more information on the potential side effects of Willby’s, read more here. There are also conditions pre-existing or acquired later which call for caution or dose adjustments when used concomitantly with our mix. We reassure you that our trained pharmacists ensure that this process of ruling out contraindications and exercising caution where relevant is aways followed. Similarly, where interactions with other medications exist, our experienced pharmacists will be in touch and take action to prevent use alongside our mix.
We hope this information has been helpful, especially if you’ve found us through a post in an online forum. It’s unfortunate that the hype of online posts can at times cause confusion and misinformation rather than the clarity that posters are usually seeking. If you’ve got further questions about what we do, how we work or the solutions we make, we welcome you to send us a DM, email or call us as we’d love to answer them.
As a team, we can’t thank you enough for your support. It truly is an honour to come alongside families and support young bubs during the first few months of their lives, and it’s one we don’t take lightly.
Thank you again, we’re grateful for a community of people and customers like you.
The Willby’s Team