Safety Alerts & Recalls
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Physicians Total Care, Inc Recalls Several Lots of Morphine Sulfate Extended Release and Immediate Release tablet, 30 mg
Physicians Total Care, Inc has recalled several lots of Morphine Sulfate Extended Release and Immediate Release tablets, 30 mg. The following lot numbers have been recalled because the labels have been mixed up and batches of Morphine Sulfate Extended released may have Morphine Sulfate Immediate released tablets and vice-versa: Morphine Sulfate Extended Release tablet, 30 mg, bottles of 60 tablets: Batch number 65IT Morphine Sulfate Immediate Release tablet, 30 mg, bottles of 120 tablets: Batch number 65J2 Morphine Sulfate is used in the treatment of pain. Morphine Sulfate is also sold under other brand names. No other lots, strengths, or brands of Morphine Sulfate were involved in this recall. To view the FDA notice about this recall, please visit: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61233&w=06272012
FDA Consumer Update: How Long Should You Take Osteoporosis Drugs?
The Food and Drug Administration (FDA) has published a Consumer Update based on an article published in the May 31, 2012 issue of The New England Journal of Medicine that reviews the benefits of osteoporosis drugs and discusses how long patients should take them. Researchers at the FDA have taken a close look at the long-term benefit of bisphosphonates, a class of medications widely prescribed to treat osteoporosis and determined that some patients may be able to stop using bisphosphonates after three to five years and still continue to benefit from their use. Bisphosphonates used for osteoporosis are known by generic and brand names such as alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), and zoledronic acid (Reclast). According to the FDA review, further investigation is needed on the long-term risks and benefits of these drugs. However, the current FDA review of available studies suggests that patients at low risk of fracture (for example, younger patients without a fracture history and with a bone mineral density approaching normal) may be good candidates for stopping bisphosphonate therapy after three to five years. In contrast, patients at increased risk for fractures (for example, older patients with a history of fracture and a bone mineral density remaining in the osteoporotic range) may benefit further from continued bisphosphonate therapy. This FDA review looked specifically at the risks of long-term use of bisphosphonates in osteopenia and osteoporosis. This review did not address the long-term use of bisphosphonates in other conditions. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm309688.htm?source=govdelivery