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Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks
AUDIENCE: Consumer, Pharmacy, Health Professional
ISSUE: FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.
Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization. Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.
BACKGROUND: OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C").
RECOMMENDATION: Speak to your health care provider if you think you or your child may have asthma. Consumers with asthma can take an active role in managing their condition by making certain they have appropriate treatments on hand in the event they experience an asthma attack or a worsening of asthma symptoms, and by consulting with a health care provider when needed.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the FDA Statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439014.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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