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In September 2023 the FDA issued a note concerning a death in a premature baby under 1000g associated with the use of a single probiotic (Evivo). Whilst the full report is awaited, the note does not consider any of the positive published literature regarding the use of probiotics in premature neonates. We can reassure our users that over 2.5 million doses of Labinic has been administered with no serious complications.
We have prepared a response which is available here
Published in 2022, a randomised, double-blinded and placebo-controlled study in 200 premature babies demonstrated that, in the group who received Labinic Drops, there were no cases of NEC and feed tolerance significantly improved. Full text PDF link here. or Full text open access article link here.
Previous meta-analyses of studies of over 19,000 babies have consistently shown a substantial reduction in necrotising enterocolitis, mortality and Late onset sepsis in premature babies recieving multistrain probiotics. A recent review showed a significant reduction in NEC and mortality in a UK NICU using Labinic Drops. Labinic has been used even in the most premature babies (22 weeks onwards) due to its excellent safety profile.
There are 3 strains of probiotics present in equal quantities in Labinic Drops. 0.2ml provides 2 billion probiotic bacteria of:
Labinic Drops are not classified as medicines in the UK/EU and in some other jurisdictions. In others they have an intermediate classification. Labinic Drops are classified as food supplements with no health claims permitted.
Labinic Drops are manufactured to pharmaceutical standards in specialised probiotic-only facilities. This is far more stringent than normal dietary supplement manufacturing.
- Facilities: Our new production facilities meet the international standards of Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) and are rated A-grade as a manufacturing pharmacy.
- Quality Control: Every batch undergoes pre- and post-production quality checks, to verify that they meet strict quality and safety standards. This is supervised by a Pharmacist and a Microbiologist.
- Contaminant checks: Labinic is manufactured in positive-pressure clean-room conditions. Full bacterial and fungal contaminant monitoring is carried out and available for every batch.
- Live strain viability counts: Certificates of Compliance and Certificates of Analysis are produced for every batch. This includes live counts at time of manufacture. In addition, we have conducted 2 year stability testing, at different environmental temperatures. The live CFU count at the end of shelf-life meets the Conformance Standards.
Exposure to antibiotics (either at Caesarean Section, through breast milk or from courses of antibiotics) can cause intestinal dybiosis (disruption of the normal healthy gut microbiome) in babies. In addition, antacids (e.g. gaviscon, omeprazole, lanzoprazole) can also cause dysbiosis. This may cause reflux, abdominal pain, excessive/painful wind, diarrhoea and/or mucousy stools.
Labinic Drops can help to correct a dysbiosis and assist in the restoration of a more normal microbiome, with subsequent resolution of symptoms.
Labinic Drops represent great value. Labinic is manufactured to pharmaceutical standards and provides 2 billion probiotics for a very low daily price, unlike some which are much more costly. How do we deliver quality and value to customers?
The costs of NEC are substantial worldwide (figures adjusted for inflation). In the USA, the (additional) cost of NEC per patient is approximately $23-30,000 for medical and surgical NEC respectively (Johnson ).
In the UK, the annual cost of treatment for NEC to the NHS is approximately £22m (Pokhrel). Surgical NEC is more costly (£27,000 per patient) compared to medical NEC (£2,500) (Renfrew). The costs of sepsis are higher, approx £58m annually (Mahon). It is also possible to assign costs of mortality and disability based on lost QALYs.
Based on the meta-analysis reductions in NEC, mortality and sepsis, we estimate that if every premature baby born in the NHS (UK) at less than 34 weeks was given Labinic Drops once they had started milk feeds, and that Labinic was continued until 37 weeks corrected gestation, then the NHS could save up to £20 million every year (including the cost of the Labinic Drops), based on a conservative reduction by 30% of these morbidities. If only NEC is considered, a saving of up to £11m annually is estimated based on a 50% reduction.
None of this includes the suffering and distress caused by these potentially modifiable conditions, nor any disease modification to a less severe pathophysiology.
Live bacterial preparations such as Labinic Drops should be handled and used with sensible precautions and care. Whilst they are generally recognised as safe, there are rare reported cases of infections arising from use of probiotics particularly in immunocompromised individuals, such as extremely preterm babies and patients receiving immune suppressants, patients with damaged intestinal tract (e.g. intestinal perforations and necrotising enterocolitis) where the live bacteria can enter the blood stream. It is likely that if the gut is developing inflammation, this heightens the risk of bacterial translocation to the bloodstream, which clinicians should consider in their risk assessement.
One report of bifidobacteraemia infection has been reported from the use of Labinic Drops, with the baby having a good outcome (Clarke). Over 2.5 million doses have been given to date (2023), indicating an excellent safety profile.
In any patient who becomes unwell who is receiving Labinic Drops, the administration should be ceased immediately and appropriate investigations and treatment commenced. Labinic bacteria do not carry antibiotic resistance genes, and would normally be sensitive to combinations of Penicillin/Gentamicin, Ampicillin/Gentamicin, Meropenem/Vancomycin, Piptazobactam/Vancomycin, Cefotaxime/Vancomycin although the advice of a Pharmacist and Microbiologist should always be sought.
We will add to this list of FAQs periodically
What is the sodium content of Labinic Drops? Labinic Drops contain no sodium. We have prepared a nutritional information factsheet which also confirms that Labinic contains no preservatives, sweeteners, gluten, dairy, lactose, soya or animal products, and is suitable for vegans.
Are Lactic acid producing probiotics safe in infants? There have been concerns raised that D- and L-lactate producing probiotics might cause lactic acidosis. However evidence from a 2005 clinical trial in Sweden shows that, in babies given Lactobacillus, levels of D- and L-lactate were very low and actually no different to the placebo group. There are no reports, in any age, of acidosis arising from D-lactate producing bacteria. In fact, lactate producing probiotics have been successfully used to treat bacterial overgrowth in short bowel syndrome where the condition of D-lactate acidosis uniquely exists. Furthermore, lactate is critical for myelin development in the brain. We have written a short appraisal document on this topic which contains further references.
Is Labinic available on the NHS Supply Chain? Labinic is the only probiotic approved by the NHS Supply Chain. If you have any trouble ordering Labinic on the Supply Chain, you can always order directly from us whilst we sort out the paperwork.
Will I have to wait long for my order to be fulfilled? Labinic is always in stock, and has a 2-year stable shelf-life. So we can always turn orders around in 2-3 days, and more urgently if you need it.
United Kingdom NHS and private distribution of Labinic Drops in the UK is currently directly provided by Biofloratech Ltd
Ireland Labinic Drops are available from our distribution partner MedFind Solutions
Australia and New Zealand Labinic Drops are available from our distribution partner Medsurge in Australia and New Zealand.
Southern Africa Labinic Drops are available from our distribution partner Safeline in Southern Africa.
Middle East and Hong Kong Labinic Drops are available from our distribution partner Miller and Miller.
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