FDA’s Notification on “Infinity”

 Dr.Naina Mohamed Pakkir Maideen

·       On 10^th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Infinity”.

·       Infinity is promoted and sold for weight loss on various websites, and in some retail stores.

·       FDA laboratory analysis confirmed that Infinity contains Sibutramine.

·       Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

·       Undeclared ingredient (Sibutramine) may inhibit the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine) and increase the risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases.

·       Concomitant administration of “Infinity” (Undeclared ingredient (Sibutramine))  and MAO inhibitors, may be contraindicated due to serious, fatal reactions.

·       “Infinity” (Undeclared ingredient (Sibutramine)) may interact majorly with SSRIs, SNRIs and tricyclic antidepressants and increase the risk of Serotonin syndrome.

·       The risk of upper gastrointestinal (GI) bleeding may be increased by the co-administration of “Infinity” and NSAIDs.

·       “Infinity” may interact with decongestants and increase the blood pressure and heart rate.

·       Sibutramine toxicity may be increased by the coadministration of “Infinity” and CYP3A4 enzyme inhibitors (Ketoconazole, Erythromycin, etc.).

·       FDA warns the Consumers should stop using this product immediately and throw it away. 

·       FDA advises the Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.