Safety Alerts & Recalls

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Latest Alerts

Early communication of ongoing safety review
The US FDA has issued an early communication about the ongoing review of new safety data for bisphosphanate medicines such as { drug_name }. The communication was issued by the FDA after it received reports of abnormal heart rhythms that may have been associated with bisphosphanate use. Upon initial review, it is unclear how this data should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070303.htm
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Voluntary recall of OTC cough and cold medicines for infants
The Consumer Healthcare Products Association (CHPA), on behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, today announced the voluntary withdrawal of oral infant medications from store shelves. The CHPA stressed that the voluntary withdrawal of OTC oral infant cough and cold medicines was initiated by the makers of those medications out of an abundance of caution, and that this is not a mandatory recall or a safety issue. For more information, please visit: http://www.otcsafety.org/home/Background_on_Voluntary_Withdrawal_of_Oral_Infant_Cough_and_Cold_Medicines.aspx
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Date Published Title Drug Source
2007-10-01 Early communication of ongoing safety review Zoledronic Acid FDA
2007-10-12 Voluntary recall of OTC cough and cold medicines for infants Pseudoephedrine Manufacturer
2007-10-16 Suspected association with acute pancreatitis Exenatide FDA
2007-10-24 Updated label regarding allergic reactions and psychiatric symptoms Modafinil FDA
2007-10-25 Early Communication about an Ongoing Safety Review FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Darbepoetin Alfa FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure FDA
2007-11-09 Strengthened box warning for cancer and chronic kidney failure Epoetin Alfa FDA
2007-11-14 New additions to black box warning Rosiglitazone FDA
2007-11-14 New additions to black box warning FDA
2007-11-14 New additions to black box warning Metformin with Rosiglitazone FDA
2007-11-14 Early Communication about an Ongoing Safety Review Cefepime FDA
2007-11-16 Voluntary recall of 600mg and 800mg tablets Gabapentin Manufacturer
2007-11-20 FDA reviewing cases of suicidal ideation and occasional suicidal behavior Varenicline FDA
2007-11-27 Revised pregnancy rating Mycophenolate FDA
2007-12-04 Revised prescribing information regarding severe hyponatremia and seizures Desmopressin FDA
2007-12-18 Recall of selected 180mg and 240mg bottles Thyroid FDA
2007-12-18 Recall of selected 5mg tablets Glyburide FDA
2007-12-21 Drug information update on Fentanyl Transdermal System (marketed as Duragesic) Fentanyl FDA
2008-01-03 FDA Communication Regarding Thyroid Medication Levothyroxine FDA