Safety Alerts & Recalls

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Latest Alerts

Revised prescribing information regarding severe hyponatremia and seizures
The FDA has notified health professionals today that certain patients taking { drug_name } are at risk for developing low sodium levels (also known as "hyponatremia"), which can result in seizures and/or other serious medical problems. Children using { drug_name } nasal spray appear to be particularly susceptible to these problems. As a result, the FDA has communicated that { drug_name } nasal spray is no longer approved for the treatment of bed wetting (primary nocturnal enuresis) or patients who have had problems with low sodium in the past. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm
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Revised pregnancy rating
This alert involves new information regarding the safety of { drug_name }. The FDA has issued a warning today that { drug_name } may increase the risk of developing fetal malformations or pregnancy loss in the first trimester. This advice was issued after the FDA received reports of pregnancy loss and congenital malformations that may have been linked to { drug_name } use. The pregnancy category for this drug has been changed from a C (risk of fetal harm cannot be ruled out) to a D (positive evidence of fetal risk). For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm072438.htm
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Date Published Title Drug Source
2007-12-04 Revised prescribing information regarding severe hyponatremia and seizures Desmopressin FDA
2007-11-27 Revised pregnancy rating Mycophenolate FDA
2007-11-20 FDA reviewing cases of suicidal ideation and occasional suicidal behavior Varenicline FDA
2007-11-16 Voluntary recall of 600mg and 800mg tablets Gabapentin Manufacturer
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
2007-11-09 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
2007-10-25 Early Communication about an Ongoing Safety Review FDA
2007-10-24 Updated label regarding allergic reactions and psychiatric symptoms Modafinil FDA
2007-10-16 Suspected association with acute pancreatitis Exenatide FDA
2007-10-12 Voluntary recall of OTC cough and cold medicines for infants Pseudoephedrine Manufacturer
2007-10-01 Early communication of ongoing safety review Alendronate FDA
2007-10-01 Early communication of ongoing safety review Alendronate and Vitamin D FDA
2007-10-01 Early communication of ongoing safety review Etidronic Acid FDA
2007-10-01 Early communication of ongoing safety review Ibandronate Sodium FDA
2007-10-01 Early communication of ongoing safety review Pamidronate Disodium FDA