US drug authorities warn of the risk of homeopathic remedies

According to the FDA( Food & Drug Administration), many children in the US have suffered life-threatening side effects from taking homeopathic remedies for teething problems. 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 Remedies for Teething Problems in the US Causes Severe Side Effects in Many Children Picture: Wolfisch / fotolia.com

Risks Should Be Eliminated with Homeopathic Remedies
When children's teeth are growing, many children suffer from pain. They often cry, seek the closeness of their parents and need more attention. Special homeopathic remedies based on Belladonna( Black Belladonna) are intended to 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 from containing belladonna alkaloids
However, the globules and gels against teething pain are, according to the FDA, likely to have a marked effect - albeit of an extremely risky. 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 more rigorous examination of the preparations. The experts found that the content of belladonna alkaloids( atropine and scopolamine) in the globules and gels varies greatly and is 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, according to the FDA's communication.

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    Infant and Childhood Risk
    The FDA warns that homeopathic remedies containing belladonna pose an unnecessary risk to infantsand children."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 identified
    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
    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 to "SPIEGEL Online".The six homeopathic remedies that have been 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 verification
    In Germany - unlike in the US - before the market launch, the extent to which the producers can prove the safety, the "SPIEGEL" further reports. Producers must also prove that they are produced 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 BfArM, a special commission is evaluating homeopathic remedies for which approval 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, "says 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" explained 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. A maximum of 6 times a day should be taken.

    Scientific Review Aim of the Policy
    Overall, a scientific debate on the subject of homeopathy is urgently required in Germany and also desired by the policy. 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 treating children with autism.

    Review the potential of homeopathy
    A scientific evaluation of homeopathy is generally to be endorsed, since on the one hand the benefit to patients can be checked and unnecessary risks avoided. On the other hand, significant cost-saving potentials 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 only equivalent to the placebo effect, the application could well be worth it, for example for complaints for which no other medicines are available.(fp)

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 now warns against certain homeopathic remedies, as taking them can have life-threatening consequences for children.

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