News Tagged ‘black box warning

FDA considers expanding indication for Cymbalta; side effects SJS, TEN

A Food and Drug Administration () advisory committee has narrowly voted to recommend that the indication for Eli Lilly’s antidepressant Cymbalta (duloxetine) be expanded to include use as a treatment for chronic musculoskeletal pain. The Anesthetic and Life Support Drugs Advisory Committee also voted that the benefits were minimal but outweighed the risks, which includes a black box warning of suicidality in children, adolescents and young adults; a potential for liver damage; and a risk of developing the rare skin disease Stevens Johnson Syndrome (SJS) and its more serious form, toxic epidermal necrolysis (TEN).

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Pepcid linked to serious skin reaction

th 50174 45470 famotidine 100x100Famotidine, the heartburn drug most known by the brand name Pepcid, is yet another drug that has been linked to a deadly skin reaction known as toxic epidermal necrolysis (TEN), the most serious version of Stevens Johnson Syndrome (SJS). Famotidine is available by both prescription and over-the-counter in either a tablet or suspension (liquid) that is taken by mouth. It is in a class of medications called H2 blockers and works by decreasing the amount of acid made in the stomach. Famotidine is used to treat ulcers, gastroesophageal reflux disease (GERD), and conditions where the stomach produces too much acid.

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Health Canada issues stronger warnings about Chamtix,Chantix

Canada 100x100Health Canada has ordered Pfizer Canada to issue stronger warnings about its smoking cessation medication Champix, also known as Chantix in the United States, because of numerous reports of serious neuropsychiatric symptoms and some cases of the potentially fatal skin disorder, Stevens Johnson Syndrome (SJS).

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