Homeopathy is safe when manufactured according to prescribed standards in the Homeopathic Pharmacopeia and taken according to fundamental homeopathic principles. The World Health Organization states, “There is no doubt about the safety of homoeopathy because the medical substances have been extremely diluted in homoeopathy drugs.”[1] A study published in 2016 reviewed 6,055 patients and concluded that homeopathy has no more side effects than placebos and conventional medicine.[2][2A] And a more recent 2020 review and meta-analysis found the “proportion of patients experiencing adverse effects was significantly higher” in conventional drugs and herbs than in homeopathy.[2B]
Homeopathic medicines are regulated as drugs under the US Federal Food, Drug and Cosmetic Act, recognized by the World Health Organization, and covered by the national health services of many countries. They are neither “approved” nor “disapproved” by the US Food and Drug Administration (“FDA”) because they have proven safe and effective with over 200 years of use in medicine, well before the creation of the FDA. This is different than conventional pharmaceuticals which have to undergo extensive testing because there is no history of safety or efficacy.
Instead, “individual homeopathic ingredients marketed for sale in the United States have been reviewed for homeopathic efficacy, toxicology, adverse effects, and clinical use by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) and are listed (monographed) in the Homeopathic Pharmacopoeia of the United States (HPUS).”[2C] They must meet the standards for strength, quality, and purity set forth in the HPUS and the FDA determines the conditions under which they may be marketed in the US.[3] They are subject to the same regulatory requirements as other drugs[4] and those meeting FDA and HPUS guidelines are marked “HPUS” on the label.
The FDA’s top concern is patient safety and its enforcement priorities are on those drugs that pose the greatest risk to patients. An FDA report from 2000 states that annually there are 7,000 deaths in the US due to drug reactions from conventional pharmaceuticals.[5] This death toll was prior to the opioid epidemic so is presumably much higher today. Conversely, because a significant body of evidence supports the safety of homeopathic medicines,[6][7][8][8A] its non-addictive nature,[9] and effectiveness for myriad conditions,[10] homeopathic medicines have generally not been a priority, while the FDA focuses on riskier drugs. In fact, a 2015 analysis of all reports to American Association of Poison Control Centers shows homeopathy accounts for less than 1% of all calls (not necessarily adverse events), far below homeopathy’s market share.[11]
However, this does not mean that homeopathic medicines can be taken without regard for safety. These medicines, if taken in higher doses than required or for longer than needed or in particularly sensitive people, can create symptoms.[12] If purchased from unscrupulous vendors, there is no guarantee they were manufactured correctly. They should not be used above the 30C potency or for chronic disease or pathological changes without the help of a professional or in an emergency. And they should never be the sole method of treatment in emergency or life threatening conditions.
As with any pharmaceutical or food product, when the FDA learns of potential problems, it intervenes. In 2018, the FDA issued recalls for products manufactured by 63 companies including names like Bayer, CVS Health, Kotex.[13] Recently, over 60 million Americans were affected by the recall of several blood pressure medicines due to the presence of trace amounts of cancer causing substances.[14] And in April 2020, the FDA pulled the popular medicine Zantac (and all ranitidine drugs) due concerns these contain cancer causing agents.[15] By contrast, in 2018, seven companies[16] voluntarily withdrew products labeled as homeopathic from store shelves due to concerns with possible microbial contamination. There were no adverse health effects reported in these cases.[17] Adverse effects were reported regarding Hyland’s teething tablets in 2010 and again in 2016. In 2010, the FDA found a quality control issue with a source material at a Hyland’s manufacturing plant and also found that some children had taken too much medicine due to the bottles lacking child-resistant caps.[18] The 2016 reports are still under investigation.[18] Hyland’s teething tablets are not available anymore.
References
[1] Poiteven, B. Integrating homeopathy in health system, Bulletin of the World Health Organization. 1999; 772 (2): p. 160.
[2] Stub T, Musial F, Kristoffersen AA, et al. Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2016 Jun;26:146–63; and Stub M, Kristofferson AE, Alraek T, et al. Risk in homeopathy: Classification of adverse events and homeopathic aggravations – A cross sectional study among Norweigian homeopathic patients. Complement Ther Med. 2015 Aug; 23(4):535-43. These conclusions are at odds with Posadzki, Alotaibi and Ernst, who concluded in 2012 that “homeopathy has the potential to harm patients…. Clinicians should be aware of its risks and advise patients accordingly.” The latter study relied on cases from around the world where patients overdosed, failed to follow directions, or took medicine that was tainted from unregulated manufacturers. As a result, their study is not helpful to practitioners trying to counsel their patients and is analogous to saying conventional pharmaceuticals are unsafe because people have overdosed, failed to follow directions, or ingested tainted products. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a systematic review of published case reports and case series. Int J Clin Prac, 2012 Dec; 66; 12: 1178-88.
[2A] See also, Jong MC, Jong MU, Baars EW. Adverse drug reactions to anthroposophical and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases. Pharmacoepidemiol Drug Saf. 2012 Dec; 21(12): 1295-301. (Adverse drug reactions associated with injections was less than 4 per million and classified as very rare, most were listed reactions and one quarter were local reactions)
[2B] Stub T, Kristoffersen A, Overvag, et al. Adverse effects in homeopathy. A systematic review and meta-analysis of observational studies. Explore. 28 Nov 2020.
[2C] Consumer Healthcare Products Assn. FAQs About Homeopathic Medicine. Retrieved on May 31, 2021.
[3] Drugs Labeled As Homeopathic – Guidance for FDA Staff and Industry. Draft Guidance.
[4] Id.
[5] FDA. Preventable Adverse Drug Reactions: A Focus on Drug Interactions. Retrieved on Mar 22, 2019 from https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm110632.htm
[6] Gummin D, Mowry J, Spyker D, et al. 2017 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 35th Annual Report. Clinical Toxicology. Retrieved on Mar 22 2019 from https://piper.filecamp.com/1/piper/binary/3po2-fdldl37j.pdf ; Gummin, D, Mowry J, Spyker, et al. 2016 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS); 34th Annual Report. Clinical Toxicology. Retrieved on Mar 2, 2019 from https://piper.filecamp.com/1/piper/binary/3l6m-flnpglqj.pdf
[7] Dantes F, Rampes H, Do homeopathic medicines provoke adverse effects? Conference proceedings: Improving the success of homeopathy. Royal London Homoeopathic Hospital. 1999; p70-74. and Br Homeopathic J. 2000; 89(Suppl): S35-538 https://www.ncbi.nlm.nih.gov/pubmed/10939781
[8] Stub T, Musial F, Kristoffersen AA, et al., supra.
[8A] Kirby B. Safety of homeopathic products. J Royal Soc Med. 2002 May; 95(5):221-22.
[9] Ronald D. Whitmont, M.D. Pain Management, The Opioid Epidemic. Retrieved from: https://www.homeopathicmd.com/2018/10/pain-management/
[10] Cucherat, M., Haugh, M.C., Gooch, M., and Boissel, J.-P. Evidence of Clinical Efficacy of Homeopathy: A Meta-Analysis of Clinical Trials. European Journal of Clinical Pharmacology. 2000. 56(1):27-33. https://www.ncbi.nlm.nih.gov/pubmed/10853874
[11] Green, Krenezelok and Reynolds, National Poison Data System (NPDS) Summary of Reported Homeopathic Exposures, 2005-2014 (Rocky Mountain Poison Control Center, 2015).
[12]Symptoms arising in this regard are called “proving” symptoms. Provings are tests where a remedy is administered to healthy people over time in order to cause symptoms. By learning the symptoms the substance causes, researchers know which symptoms may be cured in a sick person.
[13] https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm589282.htm
[14] https://www.cnn.com/2019/02/22/health/fda-recall-valsartan-arbs/index.html
[16] None of the seven companies were members of the American Association of Homeopathic Pharmacists, which requires adherence to a strict code of ethics.
[17] https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
[18] https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230762.htm
[19] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm