In order to compile a complete medication profile, providers are expected to include not only the prescription medications that their patients are taking, but also all medications, including over the counter [OTC] medications and dietary and herbal supplements. For that reason, it is important that providers are alert to and aware of all Federal Drug and Food Administration [FDA] releases. Dietary and herbal supplements have seen an increase in recalls in this month’s FDA MedWatch recalls and alerts. These recalls have all been issued as a result of FDA laboratory analysis of the supplements and are primarily relative to the finding of undeclared ingredients.
Joyful Slim Herb Supplement
This supplement is stated to contain natural herbs used for weight loss, but in the FDA laboratory analysis of this herbal supplement, it also contained desmethyl sibutramine, the FDA -approved drug used as an appetite suppressant for weight loss. This medication can present a significant risk to consumers with medical diagnoses or histories of coronary artery disease, congestive heart failure, arrhythmias and/or stroke, because its actions are to increase the blood pressure and pulse rate.
The company, J & H Besta Corporation, has discontinued its distribution of Joyful Slim nationwide, including its internet sales of this supplement. Consumers should not consume the product and should return it immediately to the place of purchase for a full refund. The corporation notes in its press release that based upon the FDA testing, the safety and effectiveness of the product is unknown; however, to date there have been no illnesses or injuries reported to the company in connection with this product.
Que She Herbal Supplement
These capsules were primarily marketed via the internet as an herbal supplement to be used for weight loss. This supplement was found to have many unlisted and active pharmaceutical ingredients with the potential to harm consumers. The ingredients have the potential to interact with other medications, especially cardiovascular medications, with the potential for producing a serious adverse event. The marketing materials note that this is a “Slimming Factor Capsule” that contains all natural Chinese herbs, which are blended for weight loss. Online it has been sold on websites such Bouncing Bear Botanicals, but it also could have been purchased at some retail outlet locations. The list of ingredients not listed on the label is lengthy and includes:
- Ephedrine – a stimulant drug, legally marketed over-the-counter for temporary relief of asthma, which can pose a risk to people with certain cardiovascular conditions
- Fenfluramine – a stimulant drug, which was withdrawn in 1997 from the U.S. market after studies demonstrated it caused serious heart valve damage
- Propranolol – a prescription beta blocker drug, which can pose a risk to people with bronchial asthma and certain heart conditions
- Sibutramine – a controlled substance and prescription weight loss drug. In a recent study’s preliminary findings, it had a demonstrated a relationship between this drug’s use and an increased risk of heart attack and stroke in patients with a history of heart disease.
Consumers are directed to stop taking Que She immediately and consult a health care professional. This FDA MedWatch was issued in both English and Chinese.
Vialipro Dietary Supplement
Good Health, Inc. conducted a voluntary recall of this supplement when the FDA laboratory analysis revealed that products tested contained an undeclared ingredient with the potential to interact dangerously with prescription drugs such as nitroglycerin. This was found in the lots tested, which did not comprise all of the lots released by Good Health, Inc. The major concern is for consumers with medical diagnoses such as diabetes, high blood pressure, high cholesterol or heart disease. The company’s press release lists all recalled lots, and consumers who have purchased Vialipro are directed to discontinue its use and return it to Good Health, Inc. for a refund. Distributors were also directed to stop selling Vialipro and contact Good Health, Inc. at 1(866) 607-0338 for further instructions.
Taking Action
Providers should advise patients of the FDA MedWatch recalls and provide them with the information regarding not continuing the product’s use and that a refund is available. Information about reporting adverse events or side effects should also be shared. Consumers and health care professionals are asked to report adverse events or side effects related to the use of any of these products, others with similar purposes, and/or others on the recall list, to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 800-FDA-1088 (800-332-1088)
- Completion of FDA form 3500 [Available at MedWatch http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm] and mail to: MedWatch, 600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178 (800-332-0178)
Consumers and providers are able to access the complete 2010 FDA MedWatch list by going to: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196258.htm Resources:
2010 Safety Alerts for Human Medical Products. Retrieved on July 23, 2010 from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196258.htm
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