US drug agencies warn against the risk of homeopathic supplements

Life-threatening side effects from homeopathic remedies?
Homeopathic remedies are available to treat many ailments and many parents use them with their children. Although critics and advocates have been arguing for years about the healing properties of homeopathy, at least the general assumption at least was that the preparations pose no risk. However, the US Food and Drug Administration is now warning against certain homeopathic remedies, as taking them can have life-threatening consequences for children.

According to the FDA (Food & Drug Administration), many children in the US have suffered life-threatening side effects from taking homeopathic remedies for teething. A connection with several deaths is still under review according to media reports. "Seizures, difficulty breathing, lethargy, excessive drowsiness, muscle weakness, constipation, difficulty urinating or agitation" are given by the FDA as a potential side effects with the specific homeopathic remedies.

Homeopathic remedy for teething problems in the US causes severe side effects in many children Image: Wolfisch / fotolia.com

Risks should be excluded with homeopathic remedies
When the teeth grow, many children suffer from pain. They often cry, seek the closeness of parents, and need extra attention. Special homeopathic remedies based on Belladonna (Black Belladonna) should provide relief here. Although the deadly nightshade is poisonous, in homeopathy, as invented by Samuel Hahnemann about two centuries ago, the active ingredients are diluted to such an extent that they can no longer pose any risk. This is also one of the main criticisms of homeopathy. Because the content of the active ingredients is in principle below the detection limit, so that critics assume that no effect is unfolded in the body. Any healing effects are therefore attributable to the placebo effect.

Side effects of containing belladonna alkaloids
However, according to the FDA, globules and gels against teething pain are likely to have a significant effect - albeit of an extremely risky one. After a father told the FDA last year that his children had serious side effects when taking homeopathic dentifrices, the US Food and Drug Administration (FDA) has conducted a closer examination of the preparations. The experts found that the content of the belladonna alkaloids (atropine and scopolamine) in the globules and gels varies greatly and sometimes much higher than indicated on the labels. Normally, the levels of active ingredients in homeopathic remedies should be so low that even with highly sensitive testing methods - including those used by the FDA in their laboratories - they are not easily recognizable, the FDA says.

Risk for infants and children
The FDA warns that homeopathic remedies containing belladonna may pose an unnecessary risk to infants and children, in the light of the findings. "The body's response to Belladonna in children under the age of two is unpredictable and puts them at unnecessary risk," said FDA expert Janet Woodcock. She advises parents not to give these homeopathic remedies to their children and instead seek advice from a medical professional for safe alternatives. Normally, teething can be withstood without medicines or other remedies, Woodcock continues.

Serious side effects noted
For example, the FDA may cite lethargy, excessive drowsiness, muscle weakness, constipation, seizures, and difficulty breathing as possible side effects of the preparations, with the latter rapidly reaching life-threatening proportions. The complaints are attributed to excessive concentrations of belladonna alkaloids in the preparations. The high residues of the alkaloids speak according to FDA for a poorly controlled manufacturing process. It should be emphasized that the preparations do not meet the claim of homeopathy, if too high concentrations of active substance are included. In principle, the FDA warns against misinformed homeopathic remedies.

No risk due to preparations available in this country
In Germany, according to the German Federal Institute for Drugs and Medical Devices (BfArM), there are no corresponding homeopathic remedies on the market that can pose a risk compared with "SPIEGEL Online". The six homeopathic remedies approved for teething problems have not been noticed in the past by reports of adverse effects. Other globules based on Belladonna, although also available in Germany, but by the strong dilution can be assumed that a barely detectable active ingredient content - as long as the preparation is done correctly.

Pre-market inspection
In the production here - unlike in the US - will be examined before the market launch, to what extent the producers can prove the safety, reports the "SPIEGEL" on. The producers must also prove that the production is carried out according to the principles of homeopathy. A review of the promised benefits, as provided for example for prescription drugs, however, does not take place. Thus, scientific studies on the benefits of homeopathic remedies are rather rare and it is still vividly discussed the meaning of the use of the preparations.

Commission evaluates homeopathic remedies
At the BfArM, a special commission deals with the evaluation of homeopathic remedies for which an authorization is sought. In January, it also dealt with the oral use of homeopathic medicines for teething problems. "The area of ​​application is derived from the homeopathic drug pictures. These include: Teething problems with inflammation of the oral mucosa in infants and toddlers ", so the intended approval for the product. The Commission unanimously concluded that "infants under the age of 3 months should be excluded from treatment" but that "the efficacy and safety of the claimed indication for the requested groups was demonstrated". For the dosage of the 100 mg tablets, the "Commission D" explains that per single dose one tablet is dissolved in 6 teaspoons of water and from this solution children "from 3 to 12 months 2 teaspoons" and children "from 1 to under 6 years 3 teaspoons" can take. The ingestion should take place no more than 6 times a day.

Scientific workup Aim of the policy
All in all, a scientific debate on the subject of homeopathy is urgently required in Germany and is also desired by politicians. Thus, the Parliamentary State Secretary Annette Widmann-Mauz, according to "SPIEGEL Online" the patronage for the World Physicians Congress of homeopaths 2017 in Leipzig take over. On the grounds that the scientific discourse in health care is a high priority. Patient well-being and patient safety are the highest standard of all treatment methods. At the congress, the focus will be on the effectiveness of homeopathic remedies in advanced cancers and on the treatment of children with autism.

Check the potential of homeopathy
A scientific evaluation of homeopathy is to be endorsed in principle, because on the one hand the benefit for the patients can be checked and unnecessary risks can be avoided. On the other hand, significant cost-cutting potential in the healthcare sector may be opened up here. As a rule, homeopathic treatments are much cheaper than other therapies. Even if the effect is just the placebo effect, the application could be worthwhile, for example, for complaints for which no other drugs are available. (Fp)