| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | | | TOPIC: Miss Slim by HIS: Recall - Due to the Presence of Undeclared Sibutramine AUDIENCE: Consumer, Health Professional ISSUE: HIS is recalling all lots and all presentations of Miss Slim capsules due to the presence of sibutramine in the product. Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. To date, HIS has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Miss Slim is marketed as a dietary supplement. The presence of sibutramine in Miss Slim renders it an unapproved drug for which safety and efficacy has not been established. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. RECOMMENDATIONS: - Consumers that have Miss Slim which is being recalled should stop using it.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
| | | Health professionals and consumers 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.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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