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Subscribe To Our Syndicated NewsBlack-Box Warnings Demanded for Medications
-September 5, 2008
The FDA announced this week that they have demanded black-box warnings be added to four medications.
The medications that will receive heightened warnings are all drugs used to treat arthritis and Crohn’s disease.
Medications Pose Risks
The medications of concern include Wyeth and Amgen’s Enbrel and Johnson & Johnson’s Remicade, along with Abbott Laboratories’ Humeria and UCB SA’s Cimzia.
Researchers have found that the medications pose the risk of serious fungal infections in patients and are cautioning doctors and consumers.
Fatal Reports from Consumers
The FDA is requiring the label changes are made in light of more than 45 cases of patients who died from taking the medications.
The patients reportedly developed histoplasmosis, which is a fatal respiratory disease, after being prescribed one of these four medications.
FDA officials are worried that doctors and other health-care professionals aren’t properly prescribing these medications and patients are suffering as a result.
The companies were given 30 days to make the necessary label changes or the FDA intends on taking further action.
(Source: CNN)
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