Medication Monitor

SORT BY:      Most Recent      Most Viewed     
List-View      Table-View
Generic Name (Trade Name—Company)
  • October 10, 2014

    FDA is advising consumers not to purchase or use Sit and Slim II, a product promoted and sold for weight loss on various websites and possibly in some retail stores.

    FDA laboratory analysis confirmed that Sit and Slim II contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to patients 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. These products may also interact, in life-threatening ways, with other medications a patient may be taking.

    Laboratory analysis also confirmed that Sit and Slim contains phenolphthalein, a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.

  • May 17, 2014

    FDA recently completed a new study in Medicare patients comparing dabigatran to warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction (MI), and death.

    The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, dabigatran was associated with a lower risk of clot-related strokes, bleeding in the brain, and death than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of dabigatran compared with warfarin. The MI risk was similar for the two drugs.

    Of importance, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of postmarket data. The study also used a more sophisticated analytical method to capture and analyze the events of concern.

    This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for dabigatran’s approval. As a result of these latest findings, FDA still considers dabigatran to have a favorable benefit-to-risk profile and has made no changes to the current label or recommendations for use.

    Dabigatran and warfarin are used to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation.

    Patients should not stop taking dabigatran (or warfarin) without first talking with their health professionals. Stopping the use of blood-thinning medications such as dabigatran and warfarin can increase the risk of stroke and lead to permanent disability and death. Health professionals who prescribe dabigatran should continue to follow the dosing recommendations in the drug label.

  • June 27, 2013

    Medtronic’s SynchroMed infusion pumps have been linked to four flaws that have led to 14 patient deaths since 1996, spurring FDA to place its most serious level of recall on the implantable system.

    In a statement Wednesday, Medtronic announced that earlier this month, it sent notifications to customers about the flaws that may interfere with the safe and reliable delivery of medications using the system. Medtronic spokesperson Donna Marquard said that 11 of the 14 deaths were related to the “inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump,” two deaths were attributed to “a blockage,” and one, to an electrical shortage.

    Medtronic's intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.

    Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose. Patients with questions should contact their physicians.

  • February 21, 2012

    Bedford Laboratories announced a nationwide voluntary recall of three lots of cytarabine for injection 1 g/vial (NDC #55390-133-01) because of a potential elevated risk of a lack of sterility assurance for these specific lots. An investigation of the manufacturing area resulted in this recall announcement. The affected lot numbers are 2066986 (expiration date March 31, 2014), 2111675 (expiration date April 30, 2014), and 2131148 (expiration date May 31, 2014).

    As of today, there have been no reports of any adverse events associated with the specific lots being recalled. Health care providers with questions concerning the use of the product are instructed to contact Bedford's Client Services Department at 800-562-4797.