Drugs
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2011 Drug Safety Communications
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- Acetaminophen - Addition of another concentration of liquid acetaminophen marketed for infants
12/22/2011 - Gilenya - Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)
12/20/2011 - Multaq - Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events
12/19/2011 - Zocor (simvastatin) - Revised dose limitation for Zocor (simvastatin) when taken with amiodarone
12/15/2011 - SSRI - Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies
12/14/2011 - ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults
12/12/2011 - Pradaxa - Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
12/7/2011 - Nplate and Promacta - Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)
12/6/2011 - Trilipix - Review update of Trilipix (fenofibric acid) and the ACCORD Lipid Trial
11/9/2011 - Avandia (rosiglitazone) - Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program
11/4/2011 - TNF Blockers - UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
11/3/2011 - ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
11/1/2011 - Drospirenone - Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone
10/27/2011 - Xigris [drotrecogin alfa (activated)] - Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit
10/25/2011 - Chantix (varenicline) - Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events
10/24/2011 - Linezolid (Zyvox) - Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications
10/20/2011 - Methylene Blue - Updated information about the drug interaction between methylene blue (methylthioninium chloride) and serotonergic psychiatric medications
10/20/2011 - Sprycel - Sprycel (dasatinib) and risk of pulmonary arterial hypertension
10/11/2011 - Drospirenone - Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone
9/26/2011 - Zofran (ondansetron) - Abnormal heart rhythms may be associated with use of Zofran (ondansetron)
9/15/2011 - Tumor Necrosis Factor-alpha - Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria
9/7/2011 - Saphris (asenapine maleate) - Serious allergic reactions reported with the use of Saphris (asenapine maleate)
9/1/2011 - Reclast (zoledronic acid) - New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)
9/1/2011 - Celexa (citalopram hydrobromide)- Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)
8/24/2011 - Actos (pioglitazone) - Updated drug labels for pioglitazone-containing medicines
8/4/2011 - Somatropin - Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
8/4/2011 - Diflucan - Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants
8/3/2011 - Linezolid (Zyvox®) - Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications
7/26/2011 - Methylene Blue - Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications
7/26/2011 - CardioGen-82 - FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients
7/26/2011 - Chantix (varenicline) drug label now contains updated efficacy and safety information
7/22/2011 - Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events
7/21/2011 - Bisphosphonates - Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer
7/21/2011 - CardioGen-82 - Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans
7/15/2011 - Tamiflu - Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension
7/11/2011 - Valproate - Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
6/30/2011 - ESAs - New dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
6/24/2011 - Chantix - Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease
6/16/2011 - Actos - Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
6/15/2011 - Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
6/13/2011 - 5-ARIs - 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
6/9/2011 - Simvastatin - New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
6/8/2011 - Angiotensin Receptor Blockers - No increase in risk of cancer with certain blood pressure drugs
6/2/2011 - Drospirenone - Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone
5/31/2011 - Rosiglitazone - Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
5/18/2011 - Glass Syringe - Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
5/6/2011 - Tysabri - Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
4/22/2011 - LABA - FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)
4/15/2011 - TNF Blockers - Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
4/14/2011 - Olmesartan - Safety Review Update of Benicar (olmesartan) and cardiovascular events
4/14/2011 - Revlimid - Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies
4/8/2011 - Benzocaine sprays - FDA continues to receive reports of serious and potentially fatal adverse effects with the use of benzocaine sprays for medical procedures
4/7/2011 - Benzocaine gels and liquids - Reports of serious and potentially fatal adverse effects with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
4/7/2011 - Pradaxa (dabigatran etexilate mesylate) - Patients and healthcare professionals must follow special storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules
3/29/2011 - PPI Update - Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
3/24/2011 - Kaletra - Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution
3/8/2011 - Letairis - Liver injury warning to be removed from Letairis (ambrisentan) tablets
3/4/2011 - Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate)
3/4/2011 - PPIs - Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)
3/2/2011 - Abacavir - Safety Review update of Abacavir and possible increased risk of heart attack
3/1/2011 - Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
2/22/2011 - Terbutaline - New warnings against use of terbutaline to treat preterm labor
2/17/2011 - Avandia - Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
2/3/2011 - Multaq (dronedarone) - Severe liver injury associated with the use of dronedarone (marketed as Multaq)
1/14/2011 - Acetaminophen - Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
1/13/2011 - Lantus - Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
1/12/2011
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