Medication Monitor

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  • August 4, 2011

    A series of case reports describe congenital anomalies in infants whose mothers were treated with chronic high-dose (400-800 mg/d) fluconazole therapy during their first trimester, according to an FDA safety alert. Observed birth defects included short, broad head; abnormal looking face; oral cleft; bowing of the thigh bones; thin ribs and long bones; muscle weakness and joint deformities; and congenital heart disease.

    FDA noted that the risk does not appear to be associated with low-dose fluconazole (150 mg) when used for treatment of vaginal candidiasis. Based on these new data, the pregnancy category for fluconazole is being changed from C to D for most indications, except vaginal candidiasis where it will remain a category C.

  • July 29, 2011

    FDA is warning patients not to use a potentially counterfeit product labeled as Evital for emergency contraception, according to a press release. These tablets may be in distribution in some Hispanic communities. The package reads: “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet,” by “Fluter Domull.” A photo is on FDA’s website.

  • July 28, 2011

    The maximum daily dose for single-ingredient extra-strength acetaminophen products has been lowered to 6 tablets or capsules per day (3,000 mg/day), according to an announcement made today by McNeil Consumer Healthcare. The previous recommendation was 8 tablets or capsules each day (4,000 mg/day), but reports of accidental overdoses resulting in liver toxicity has prompted the manufacturer to revise its label in an attempt to decrease the likelihood of these adverse events.

    The new product packaging will begin appearing on pharmacy shelves in this fall. In addition, McNeil will also be lowering the maximum daily dose for regular strength acetaminophen products and other adult acetaminophen-containing products sold in the U.S. beginning in 2012.

  • July 26, 2011

    FDA has announced that linezolid should not be prescribed with certain serotonergic agents such as paroxetine, venlafaxine, or amitriptyline because of the potential for serotonin syndrome. In a separate safety communication, FDA said that methylene blue should also not be used in patients receiving serotonergic agents. FDA said that it has learned of serious CNS reactions when either drug has been given to patients taking other drugs that work through the serotonin system of the brain. The mechanism involved in the drug interaction may be inhibition of monoamine oxidase A by linezolid and methylene blue, thereby inhibiting the breakdown of serotonin and producing high levels in patients taking other serotonergic agents. 

    FDA is advising clinicians that in nonemergency situations, most serotonergic drugs must be stopped at least 2 weeks before initiating linezolid or methylene blue; fluoxetine requires a 5-week lead period because of its extended half-life. Treatment with the serotonergic psychiatric medication may be resumed 24 hours after the last dose of linezolid or methylene blue.

    Use of linezolid can generally not be anticipated, since it is used in life-threatening infections such as vancomycin-resistant Enterococcus faecium (VRE) infections, nosocomial pneumonia, and complicated skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). For VRE, MRSA, and other serious infections, FDA said the availability of alternative interventions should be considered and the benefit of linezolid treatment should be weighed against the risk of serotonin toxicity. If linezolid must be administered to a patient receiving a serotonergic drug, the serotonergic drug must be immediately stopped and the patient should be closely monitored for emergent symptoms of CNS toxicity for 2 weeks (5 weeks for fluoxetine), or until 24 hours after the last dose of linezolid or methylene blue, whichever comes first.



  • July 25, 2011

    Intercharm announced that it is recalling Slimforte Slimming Capsules (Batch #20100928, Exp. 09/27/2012 and Batch #20100604, Exp. 06/03/2012), Slimforte Slimming Coffee (Batch #20100903, Exp. 09/02/2012), and Meizitang Botanical Slimming Soft Gel (Lot Code 12.24.2009, Exp. 12/23/2011) because the products were found to contain sibutramine, a controlled substance withdrawn from the U.S. market in October 2010 because of safety reasons.

    Use of sibutramine has been associated with increases in blood pressure and pulse rates and may cause serious problems in patients with a history of cardiovascular diseases.

    These dietary supplements were distributed through the Internet nationwide and internationally to Ireland.