Roche Warns About Association of Panitumumab (Vectibix) with Hypersensitivity Reactions
Amgen, Inc, the manufacturer of panitumumab (Vectibix) sent healthcare professionals a letter to warn about new reports of serious hypersensitivity reactions, including anaphylaxis, reported in patients receiving panitumumab (Vectibix). These infusion-related reactions are unpredictable and can occur suddenly. Mild to moderate infusion-related reactions, including chills, difficulty breathing, redness or flushing of the face or body, high or low blood pressure, fever, fast heart rate, and vomiting, occur in about 3% of patients. However, severe infusion reactions, including anaphylaxis, swelling of the face, mouth, and throat, extreme difficulty breathing, and low blood pressure requiring treatment, may occur and are potentially life-threatening. Hypersensitivity reactions occurring more than 24 hours after infusion have also been reported. Patients should be aware of the possibility of a late onset reaction and should contact their physician if symptoms of a hypersensitivity reaction occur. This information has been included in an update to the product information for the use of panitumumab (Vectibix) . To view the letter to healthcare professionals about panitumumab (Vectibix), please visit: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON081755&RevisionSelectionMethod=Latest This safety information was also reported in the May 2010 Drug Safety Update from the Medicines and Healthcare products Regulatory Agency (MHRA), and can viewed at: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON081863
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Product Information For Simvastatin (Zocor) and Simvastatin Combined With Ezetimibe (Inegy) Warns About Risks of Muscle Pain and Weakness
The May 2010 Drug Safety Update from the Medicines and Healthcare products Regulatory Agency (MHRA) reports that the simvastatin (Zocor) product information (Summary of Product Characteristics and Patient Information Leaflet) has been updated to include warnings about increased risk of myopathy (muscle pain or weakness) in patients receiving the highest licensed dose (80 mg). Similar changes are being made to the product information for combination products that contain simvastatin, such as Inegy (simvastatin combined with ezetimibe). The 80 mg dose of simvastatin should be considered only in patients with very high cholesterol and high risk of heart related problems who have not achieved their treatment goals on lower doses. For more information, please visit: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON081863
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