April Through June 2014
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April through June 2014 Undeclared Drug Ingredient Found in MV5 Days: Updated Warnings—Current Drugs The FDA is advising consumers not to purchase or use MV5 Days, a product promoted and sold for sexual en- hancement. FDA laboratory analysis confirmed that MV5 Public Notification Regarding Male Sexual En- Days contains sildenafil, the active ingredient in the FDA hancement Products: The FDA is advising consumers approved prescription drug Viagra, used to treat ED. This not to purchase or use GoldReallas, Full Throttle On De- undeclared ingredient may interact with nitrates found in mand, 3 Hard Knights, Dick’s Hard Up, Eyeful, Liu Bian Li, some prescription drugs such as nitroglycerin and may products promoted and sold for sexual enhancement on lower blood pressure to dangerous levels. Men with diabe- various websites and in some retail stores. FDA laboratory tes, high blood pressure, high cholesterol, or heart disease analysis confirmed that these products contained the fol- often take nitrates. lowing undeclared drug ingredients: MV5 Days is a product promoted and sold for sexual en- • GoldReallas: sildenafil and thiosildenafil hancement on various websites and in some retail stores. • Full Throttle On Demand: propoxyphenyl sildenafil FDA is recommending that consumers do not purchase or • 3 Hard Knights: sildenafil and thiosildenafil use MV5 Days. (5/16/14) • Dick’s Hard Up: tadalafil • Eyeful: hydroxythiohomosildenafil Lunesta—Next Day Impairments: The FDA has noti- • Liu Bian Li: sildenafil fied health professionals and their medical care organiza- These undeclared ingredients may interact with nitrates tions of a new warning that the insomnia drug Lunesta found in some prescription drugs such as nitroglycerin and (eszopiclone) can cause next-day impairment of driving may lower blood pressure to dangerous levels. and other activities that require alertness. FDA recom- Sildenafil is the active ingredient in the FDA approved pre- mends a decreased starting dose of Lunesta to 1 mg at bed- scription drug Viagra, used to treat erectile dysfunction time. Women and men are equally susceptible to impair- (ED). The other undeclared ingredients are structurally ment from Lunesta, so the recommended starting dose of 1 similar to sildenafil. mg is the same for both. FDA approved changes to the Consumers should stop using these products immediately Lunesta prescribing information and the patient Medica- and throw them away. Consumers who have experienced tion Guide to include these new recommendations. The any negative side effects should consult a health care pro- drug labels for generic eszopiclone products will also be fessional as soon as possible. (6/3/14) updated to include these changes. A study of Lunesta found that the previously recommended Asset Bold: Undeclared Drug Ingredient: The FDA dose of 3 mg can cause impairment to driving skills, is advising consumers not to purchase or use Asset Bold, a memory, and coordination that can last more than 11 hours product promoted and sold for weight loss. FDA laboratory after receiving an evening dose. Despite these driving and analysis confirmed that Asset Bold contains sibutramine. other problems, patients were often unaware they were Sibutramine is a controlled substance that was removed impaired. The new lower recommended starting dose of 1 from the market in October 2010 for safety reasons. The mg at bedtime will result in less drug in the blood the next product poses a threat to consumers because sibutramine day. is known to substantially increase blood pressure and/or Health care professionals should follow the new dosing pulse rate in some patients and may present a significant recommendations when starting patients on Lunesta. Pa- risk for patients with a history of coronary artery disease, tients should continue taking their prescribed dose of congestive heart failure, arrhythmias, or stroke. These Lunesta and contact their health care professionals to ask products may also interact, in life-threatening ways, with about the most appropriate dose for them. FDA is continu- other medications a consumer may be taking. ing to evaluate the risk of impaired mental alertness with Asset Bold is a product promoted and sold for weight loss the entire class of sleep aid drugs, including over-the- on various websites and in some retail stores. counter drugs available without a prescription, and will The FDA is recommending that consumers do not purchase update the public as new information becomes available. or use Asset Bold. (5/16/14) (5/15/14) www.AmericanHealthCare.com For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 Pradaxa Study by FDA: Increased Risk of GI Bleed- life-threatening ways, with other medications a consumer ing: The FDA recently completed a new study in Medicare may be taking. patients comparing Pradaxa to warfarin, for risk of ischem- Natural Body Solution is promoted and sold for weight loss ic or clot-related stroke, bleeding in the brain, major gas- and sold on various websites and in some retail stores. trointestinal (GI) bleeding, myocardial infarction (MI), and FDA is advising consumers not to purchase or use Natural death. The new study found that among new users of Body Solution. (5/6/14) blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and Slim Trim U: Undeclared Drug Ingredient Found: death, than warfarin. The study also found an increased The FDA laboratory analysis confirmed that Slim Trim U risk of major gastrointestinal bleeding with use of Pradaxa contains sibutramine. Sibutramine is a controlled sub- as compared to warfarin. The MI risk was similar for the stance that was removed from the market in October 2010 two drugs. for safety reasons. The product poses a threat to consumers Importantly, the new study is based on a much larger and because sibutramine is known to substantially increase older patient population than those used in FDA’s earlier blood pressure and/or pulse rate in some patients and may review of post-market data, and employed a more sophisti- present a significant risk for patients with a history of cor- cated analytical method to capture and analyze the events onary artery disease, congestive heart failure, arrhythmias, of concern. As a result of these latest findings, the FDA still or stroke. These products may also interact, in life- considers Pradaxa to have a favorable benefit to risk profile threatening ways, with other medications a consumer may and have made no changes to the current label or recom- be taking. mendations for use. Slim Trim U is promoted and sold for weight loss and sold Pradaxa and warfarin are used to reduce the risk of stroke on various websites and in some retail stores. and blood clots in patients with a common type of abnor- FDA is advising consumers not to purchase or use Slim mal heart rhythm called non-valvular atrial fibrillation Trim U. (5/6/14) (AF). Patients should not stop taking Pradaxa (or warfarin) with- GenStrip Blood Glucose Test Strip—Safety Risk: out first talking with their health care professionals. Stop- The FDA is advising people with diabetes and health care ping the use of blood-thinning medications such as professionals to stop using GenStrip Blood Glucose Test Pradaxa and warfarin can increase the risk of stroke and Strips because the strips may report incorrect blood glu- lead to permanent disability and death. Health care profes- cose levels. sionals who prescribe Pradaxa should continue to follow During a recent inspection of Shasta Technologies LLC, the the dosing recommendations in the drug label. (5/13/14) FDA found extensive violations of federal regulations in- tended to assure the quality of products in the manufactur- Asset Bee Pollen—Undeclared Drug Ingredient: ing of GenStrip Test Strips. FDA found that Shasta Tech- The FDA is advising consumers not to purchase or use As- nologies did not have in place many of the requirements of set Bee Pollen, a product promoted and sold for weight a quality system. Without assurance of an adequate quality loss. FDA laboratory analysis confirmed that Asset Bee Pol- system, the FDA believes that the strips could report incor- len contains sibutramine. Sibutramine is a controlled sub- rect blood glucose levels. stance that was removed from the market in October 2010 GenStrip Blood Glucose Test Strips, sold by Shasta Tech- for safety reasons. The product poses a threat to consumers nologies LLC, are "third-party" blood glucose monitoring because sibutramine is known to substantially increase test strips. Shasta’s GenStrips are advertised for use with blood pressure and/or pulse rate in some patients and may the LifeScan OneTouch family of glucose meters (e.g. Ultra, present a significant risk for patients with a history of cor- Ultra 2 and Ultra Mini). onary artery disease, congestive heart failure, arrhythmias, Discontinue use of GenStrip Blood Glucose Test Strips. or stroke. These products may also interact, in life- FDA recommends the use of alternative glucose test strips threatening ways, with other medications a consumer may that are designed for use with the LifeScan OneTouch fami- be taking. ly of glucose meters. (4/29/14) Asset Bee Pollen is a product promoted and sold for weight loss on various websites. FDA Finds Undeclared Drug Ingredients in The FDA is recommending patients not purchase or use S.W.A.G: The FDA is advising consumers not to purchase Asset Bee Pollen. (5/12/14) or use S.W.A.G, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Natural Body Solution—Undeclared Drug Ingredi- S.W.A.G contains sildenafil, the active ingredient in the ent: The FDA laboratory analysis confirmed that Natural FDA approved prescription drug Viagra, used to treat ED.