Safety Alerts & Recalls

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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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Date Published Title Medicine Source
2010-06-08 Roche Warns About Association of Panitumumab (Vectibix) with Hypersensitivity Reactions Panitumumab Manufacturer
2010-06-08 Product Information For Simvastatin (Zocor) and Simvastatin Combined With Ezetimibe (Inegy) Warns About Risks of Muscle Pain and Weakness Simvastatin MHRA
2010-06-08 MHRA Warns Again: Tacrolimus Formulations Not Interchangeable Tacrolimus MHRA
2010-06-08 Studies Show Small Increased Risk of Bone Fractures in Patients Receiving Common Antidepressant Medicines Paroxetine MHRA
2010-06-08 Antidepressants During Pregnancy: Rare Risk of Persistent Pulmonary Hypertension in the Newborn Paroxetine MHRA
2010-06-08 Fabrazyme Shortage To Last To At Least The End of September 2010 Agalsidase Beta Manufacturer
2010-06-08 Cerezyme Shortage To Last To At Least The End of July 2010 Imiglucerase Manufacturer
2010-06-08 Patient and Caregivers Need To Know Correct Techniques for the Use of the Exelon Patch Rivastigmine Manufacturer
2010-06-08 Roche Warns About Association of Bevacizumab (Avastin) with Hypersensitivity and Infusion Reactions Bevacizumab Manufacturer
2010-06-08 Palifermin (Kepivance) Restricted to Patients Who Receive Both Radiotherapy and Chemotherapy Prior to Bone Marrow Transplant Palifermin Manufacturer
2010-06-03 Pharmacy Level Recall of Gabapentin 100mg Capsules: Safety Warnings Missing From Patient Information Leaflet Gabapentin MHRA
2010-05-13 Pharmacy Level Recall of Several Batches of Mirtazapine 15 mg and 45 mg Tablets Mirtazapine MHRA
2010-05-12 Proton Pump Inhibitors (PPIs) May Be Linked to Bone Fractures and Bacterial Infections Omeprazole MediGuard CRT
2010-04-16 Regranex for Diabetic Ulcers: Avoid Use In Patients With Any Known Current Cancer Becaplermin MHRA
2010-04-16 MHRA and Manufacturers Warn About Kidney Problems with Aclasta/Zometa Zoledronic Acid MHRA
2010-04-16 MHRA Discusses Clopidogrel (Plavix) and Proton Pump Inhibitors Interaction Clopidogrel MHRA
2010-04-16 MHRA Discusses Risk of Venous Thromboembolism (VTE) Associated with Yasmin Drospirenone with Ethinyl Estradiol MHRA
2010-04-16 Rosiglitazone (Avandia, Avandamet): Update to MHRA's March 2010 Message Rosiglitazone MHRA
2010-04-05 MHRA Drug Safety Update Discusses Fluoxetine Use During Pregnancy Fluoxetine MHRA
2010-04-05 Recall Vascace: Safety Warnings Not Included in Patient Information Leaflet Cilazapril MHRA