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US drug agencies warn of the risk of homeopathic medicines


Life-threatening side effects from homeopathic drugs?
Homeopathic remedies are available to treat numerous ailments and many parents use them on their children. Although critics and advocates have been arguing about the healing properties of homeopathy for years, the general assumption was that the preparations pose no risk. However, the US drug agency is now warning of certain homeopathic drugs, since taking them could have life-threatening consequences for children.

According to the FDA (Food & Drug Administration), numerous children in the United States have experienced life-threatening side effects from taking homeopathic remedies for teething problems. A connection with several deaths is currently being reviewed, according to media reports. "Seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, constipation, difficulty urinating or agitation" are listed by the FDA as an impending side effect with the special homeopathic drugs.

Risks should be excluded with homeopathic remedies
When the teeth grow, many children experience pain. They cry frequently, seek closeness to their parents and need increased attention. Special homeopathic remedies based on belladonna (black belladonna) are said to provide relief here. The deadly cherries are poisonous, but 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 a 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 critics assume that there is no effect in the body. Any healing effects can therefore be attributed to the placebo effect.

Side effects from contained Belladonna alkaloids
However, according to the FDA, the globules and gels against pain during teething can be expected to have a clear effect - albeit an extremely risky one. After a FDA father reported serious side effects from his child taking homeopathic dentifrices last year, the U.S. Medicines Agency conducted a more thorough investigation 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 significantly higher than that stated on the labels. Typically, the levels of active ingredients in homeopathic medicinal products should be so low that they cannot be easily identified even by highly sensitive test methods, including those used by the FDA in their laboratories, the FDA said.

Risk to infants and children
The FDA warns against the results of the investigation that homeopathic dentifrices containing Belladonna can pose an unnecessary risk to infants and children. "The body's response to Belladonna in children under the age of two is unpredictable and puts it 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. The teething can usually be survived without medication or other remedies, Woodcock continues.

Serious side effects noted
The FDA mentions, for example, lethargy, excessive sleepiness, muscle weakness, constipation, seizures and breathing difficulties as possible side effects of the preparations, the latter quickly becoming life-threatening. The complaints are attributed to excessive concentrations of the Belladonna alkaloids in the preparations. According to the FDA, the high residues of the alkaloids indicate a poorly controlled manufacturing process. It should be emphasized that the preparations do not meet the requirements of homeopathy if the active substance concentrations are too high. In principle, the FDA warns against improperly manufactured homeopathic drugs.

No risk from preparations available in this country
According to the Federal Institute for Drugs and Medical Devices (BfArM), there are no corresponding homeopathic drugs on the market in Germany compared to "SPIEGEL Online" that could pose a risk. In the past, the six homeopathic remedies approved against complaints of teething were not noticed by reports of undesirable effects. Other globules based on Belladonna are also available in Germany, but due to the strong dilution, an almost undetectable active ingredient content can be assumed - as long as the preparation is carried out correctly.

Pre-launch review
In this country - unlike in the USA - before the market launch, it is checked to what extent the producers can prove that it is safe, reports the “SPIEGEL”. The producers must also demonstrate that the production is carried out according to the principles of homeopathy. However, the promised benefits, such as those intended for prescription drugs, are not reviewed. For example, scientific studies on the benefits of homeopathics are rather rare and there is still lively discussion about the purpose of using the preparations.

Commission evaluates homeopathic remedies
At the BfArM, a special commission deals with the assessment of homeopathic medicinal products 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 images. These include: Teething complaints with inflammation of the oral mucosa in infants and toddlers, ”says the intended approval for the product. The commission unanimously came to the conclusion that "infants under 3 months should be excluded from treatment", but "the effectiveness and harmlessness of the application area for the groups of people requested is proven". Regarding the dosage of the 100 mg tablets, “Commission D” explains that one tablet per single dose is dissolved in 6 teaspoons of water and children “from 3 to 12 months 2 teaspoons” and children “from 1 to under 6 years 3 teaspoons” from this solution. can take. The dose should be taken a maximum of 6 times a day.

Scientific review Aim of politics
All in all, a scientific examination of the topic of homeopathy is urgently required in Germany and also very much desired by politicians. According to "SPIEGEL Online", the Parliamentary State Secretary Annette Widmann-Mauz will assume the patronage for the 2017 World Congress of Homeopaths in Leipzig. On the grounds that the scientific discourse in health care is of great importance. Patient well-being and patient safety are the highest standard of all treatment methods. At the congress, the effectiveness of homeopathic remedies for advanced cancer and for the treatment of children with autism will be two main topics.

Check the potential of homeopathy
A scientific assessment of homeopathy is fundamentally in favor, since on the one hand the benefits for the patient can be checked and unnecessary risks can be avoided. On the other hand, there may be considerable cost savings potential in the healthcare system. Because homeopathic treatments are usually much cheaper than other therapies. Even if the effect only corresponds to the placebo effect, the application could be worthwhile, for example for complaints for which no other drugs are available. (fp)

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