Patient safety, news and press releases from EMA
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- Wed, 25 Apr 2018 04:00:00 +0000: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry - MedWatch Safety Alert RSS Feed
FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018 - Wed, 25 Apr 2018 04:00:00 +0000: Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction - MedWatch Safety Alert RSS Feed
The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs. - Fri, 20 Apr 2018 14:50:00 +0000: Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination - MedWatch Safety Alert RSS Feed
Expanded recall of various kratom dietary supplements to additional lot numbers due to possible Salmonella Health Risk. - Thu, 19 Apr 2018 04:00:00 +0000: NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination - MedWatch Safety Alert RSS Feed
NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can ressult in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. - Thu, 19 Apr 2018 04:00:00 +0000: Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination - MedWatch Safety Alert RSS Feed
Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.