Medication Monitor

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  • January 5, 2016

    FDA is advising consumers not to purchase or use the following products promoted and used for sexual enhancement on various websites and in some retail stores because they contain undeclared ingredients that may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

    Rhino Big Horn 3000 contains desmethyl carbodenafil and sildenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, a prescription drug for erectile dysfunction (ED). 

    Rhino 7 Blue 9000 contains tadalafil, the active ingredient in the prescription drug Cialis, used to treat ED.

    OrgaZen 3500 contains tadalafil. 

    OrgaZen 3000 contains tadalafil. 
    Eros Power Zone 1900 contains desmethyl carbodenafil and dapoxetine. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

    Triple MiracleZen Plus 1500 mg contains sildenafil, tadalafil, and dapoxetine. Sildenafil and tadalafil are the active ingredients in Viagra and Cialis, respectively. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

    Triple MiracleZen Gold 1750 mg contains sildenafil, tadalafil, and dapoxetine.

    Triple MiracleZen Extreme 1750 mg contains sildenafil, tadalafil, and dapoxetine. 

    Diamond 3500 contains sildenafil and tadalafil.

    Xtra Zone 2600, contains sildenafil and tadalafil.

    Xtra Zone 2400 contains sildenafil and tadalafil. 

    Triple Power Zen Plus 2000 contains sildenafil and tadalafil.

    Triple Power Zen Gold 2000 contains sildenafil and tadalafil.

  • November 7, 2015

    An FDA review has determined that long-term use of the blood-thinning drug clopidogrel does not increase or decrease overall risk of death in patients with or at risk for heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.

    To investigate the increased risk of death and cancer-related death reported with clopidogrel in the DAPT trial, FDA examined the results of the DAPT trial and other large, long-term clinical trials of clopidogrel with data available on rates of death, death from cancer, or cancer reported as an adverse event.

    FDA performed meta-analyses of other long-term clinical trials to assess the effects of clopidogrel on death rates from all causes. The results indicate that long-term (12 months or longer) dual antiplatelet therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) clopidogrel and aspirin, or aspirin alone. Also, there was no apparent increase in the risks of cancer-related deaths or cancer-related adverse events with long-term treatment.

    FDA is working with the manufacturers of clopidogrel to update the label to reflect the results of the mortality meta-analysis.

    Clopidogrel is an antiplatelet medicine used to prevent blood clots in patients who have had a heart attack, stroke, or problems with the circulation in the arms and legs. It works by helping to keep the platelets in the blood from sticking together and forming clots that can occur with certain medical conditions.

    Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health professional if you have any questions or concerns about clopidogrel.

    Health professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment. See the Drug Safety Communication for more information.

  • November 4, 2015
  • October 29, 2015

    Sanofi US is voluntarily recalling all doses of epinephrine injection currently on the market under the trade name Auvi-Q, including both the 0.15-mg and 0.3-mg strengths for hospitals, retailers, and consumers. This includes lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. See the Press Release for product photos.

    As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the United States and Canada. None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

    If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences, including death.

    Auvi-Q is packaged with two active devices and one trainer device in a corrugated box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies, and hospitals.

    Sanofi US is notifying its distributors and customers by letter, fax, e-mail, and phone calls and is arranging for return and reimbursement of all recalled products.

  • January 7, 2016

    Baxter International is voluntarily recalling two lots (#C980227, #C985150) of I.V. solutions to the hospital/end user level after a costumer complaint about particulate matter, which was determined to be an insect.

    The I.V. solutions are 0.9% sodium chloride injection (250 mL Viaflex plastic container), a source of water and electrolytes and also a priming solution in hemodialysis procedures; and 70% dextrose injection (2000 mL), a source of calories and water for hydration. 

    The matter was identified before patient administration, and there have been no adverse events associated with this issue reported to Baxter to date.

    Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs.

    The recalled lots were distributed to customers and distributors in the United States between June 6, 2015, and December 16, 2015. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between the hours of 7 am and 6 pm, Central Time.