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The following articles are presented for informational purposes only. The views and opinions expressed within these articles do not necessarily state or represent those of Cerner Multum, our management, or our associates.

U.S. FDA Recalls

January 31 2012 -Linagliptin-metformin (Jentadueto by Lilly), has been approved by the FDA for the treatment of adult patients with type 2 diabetes. Prescribing Information

January 31 2012 -Axitinib (Inlyta by Pfizer), has been approved by the FDA for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.  Prescribing Information

January 31 2012 -Vismodegib (Erivedge by Genentech), has been approved by the FDA for the treatment of adults with basal cell carcinoma.  Prescribing Information

January 31 2012 -Ingenol topical (Picato by Leo Pharma), has been approved by the FDA for the topical treatment of actinic keratosis. Prescribing Information

January 31 2012 -Exenatide (Bydureon by Amylin Pharmaceuticals, Inc. and Alkermes), has been approved by the FDA in an extended release form as a once-weekly treatment for type 2 diabetes.  Prescribing Information

January 23 2012 - Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease.

A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.

BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008.

RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to tht eFDA Drug Safety Communication and News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm

 

January 20 2012 - Glucarpidase (Voraxaze by BTG), has been approved by the FDA to treat patients with toxic levels of methotrexate in their blood due to kidney failure.  Prescribing Information

January 20 2012 - Tenofovir (Viread by Gilead), has been approved by the FDA for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12. The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. The agency also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children ages 2-5. Prescribing Information

January 13 2012 - Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287710.htm

 

January 13 2012 - The MedWatch December 2011 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm284231.htm


The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:   

Multaq (dronedarone hydrochloride) tablets
Dilantin-125 (phenytoin) Oral Suspension
Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets
Relenza (zanamivir) inhalation powder
Tyzeka (telbivudine) tablets and oral solution
Capoten (captopril) Tablets   
Danocrine brand of Danazol capsules
Desferal (deferoxamine mesylate) for injection
Edarbi (azilsartan medoxomil) Tablets
Eloxatin (oxaliplatin)  for intravenous use
Heparin Sodium Injection
Isentress (raltegravir) scored, chewable tablets, film-coated tablet
Keppra (levetiracetam) Tablets and oral solution   
Onglyza (saxagliptin) tablets
Ovide (malathion) 0.5% lotion1  
PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
Plavix (clopidogrel bisulfate) tablets
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating    
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules

 

January 4 2012 - Pneumococcal 13-valent conjugate vaccine (Prevnar 13 by Wyeth), has been approved by the FDA for use in adults 50 years and older. Prescribing Information

January 4 2012 - Oxybutynin (Anturol by Antares), has been approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Prescribing Information

December 27 2011 - Azilsartan-chlorthalidone (Edarbyclor by Takeda), has been approved by the FDA for the treatment of hypertension. Prescribing Information

December 22 2011 - Raltegravir (Isentress by Merck), has been approved by the FDA to include children and adolescents from 2 to 18 years of age. Prescribing Information

December 22 2011 - Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors

ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available.  This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

BACKGROUND:  Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers,  Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen. In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

RECOMMENDATION: Read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use. 

Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Healthcare professionals should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284807.htm

 

December 20 2011 - Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.

RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

December 19 2011 - Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events

FDA completed a safety review of Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, PALLAS and ATHENA. FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.

The Multaq drug label has been revised with the following changes and recommendations:

  • Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
  • Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm

December 14 2011 - Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn

Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) 

ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as  P persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. 

FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.

BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.

RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information.
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm283696.htm

 

December 14 2011 - The MedWatch November 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.  The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm282966.htm

 

December 7 2011 - Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

ISSUE: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm

 

November 30 2011 - Zolpidem (Intermezzo by Transcept Pharmaceuticals Inc.), has been approved by the FDA for use as needed for insomnia characterized by middle-of-the-night wakening followed by difficulty returning to sleep.  Prescribing Information

November 23 2011 - Ruxolitinib (Jakafi by Incyte), has been approved by the FDA to treat patients with the bone marrow disease myelofibrosis. Prescribing Information

November 23 2011 - Asparaginase Erwinia chrysanthemi  (Erwinaze by EUSA Pharma), has been approved by the FDA as a treatment for patients with acute lymphoblastic leukemia. Prescribing Information

November 23 2011 - Aflibercept (Eylea by Regeneron), has been approved by the FDA to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older. Prescribing Information

November 23 2011 - Bupivacaine liposome (Exparel by Pacira Pharmaceuticals), has been approved by the FDA for administration into the surgical site to produce postsurgical analgesia. Prescribing Information

November 21 2011 - The MedWatch October 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm279222.htm

 

November 9 2011 - Trilipix (fenofibric acid): Drug Safety Communication - Label Change

ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone.

Information from the trial has been added to the Important Limitations of Use and Warnings and Precautions sections of the Trilipix physician label and to the patient Medication Guide.

BACKGROUND: Trilipix (fenofibric acid) was approved by FDA in 2008 to treat cholesterol in the blood by lowering the total amount of triglycerides and low-density lipoprotein (LDL) cholesterol, and increasing the high-density lipoprotein (HDL) cholesterol.

RECOMMENDATION: Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in patients in two large randomized controlled trials of patients with type 2 diabetes mellitus; healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm279185.htm

 

November 9 2011 - Cetuximab (Erbitux by Bristol-Myers Squibb), has been approved by the FDA for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer. Prescribing Information

November 4 2011 - Rivaroxaban (Xarelto by Johnson & Johnson), has been approved by the FDA for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. Prescribing Information

November 4 2011 - Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

[UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include:

  • patient characteristics (age, gender, no patient identifiers)
  • risk factors for malignancy
  • exposure to other immune suppressing products or products with risk of malignancy
  • indication for TNF blocker treatment
  • TNF blocker exposure (duration, dose)
  • cancer diagnosis (date of diagnosis, stage)
  • biopsy results
  • outcomes of malignancy (treatments, event outcome)

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251443.htm

 

October 26 2011 - Clobazam (Onfi by Catalent Pharma Solutions and Lundbeck), has been approved by the FDA as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older.  Prescribing Information

October 25 2011 - Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit

ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

BACKGROUND: Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

RECOMMENDATION: Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. All remaining Xigris product should be returned to the supplier from whom it was purchased.

[10/25/2011 - Drug Safety Communication1 - FDA]

 

October 24 2011 - Chantix (varenicline)

[UPDATE 10/24/2011] FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; e.g., NicoDerm patches). However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events (see the 10/24/2011 Drug Safety Communication below for more information).

Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events, and results from this study are expected in 2017.

[UPDATE 05/16/2008] FDA informed healthcare professionals and patients that as the Agency’s review of Chantix safety data has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. Prescribing information for Chantix was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available. If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking Chantix and contact their healthcare professional.

[Posted 11/20/2007] FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

[10/24/2011 – Drug Safety Communication1 - FDA]
[May 2008 - Label2 - Pfizer]
[May 16, 2008 - Drug Information Page3 - FDA]
[May 16, 2008 - Medication Guide4 - Pfizer]
[May 16, 2008 - Information for Healthcare Professionals sheet5 - FDA]
[November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix)6 - FDA]

 

October 21 2011 - Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

[UPDATED 10/21/2011] FDA updated healthcare professionals and the public on the potential drug interaction between methylene blue and serotonergic psychiatric medications. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome in patients given serotonergic psychiatric medications and methylene blue occurred in the context of parathyroid surgery, which involved the intravenous administration of methylene blue as a visualizing agent. Methylene blue doses ranged from 1 mg/kg to 8 mg/kg.

Because methylene blue is not an FDA-approved drug at this time, and limited data exist regarding its use in various settings, it is not known whether there is a risk of serotonin syndrome in patients taking serotonergic psychiatric medications who are given methylene blue by other routes (e.g., orally or by local tissue injection) or at intravenous doses lower than 1 mg/kg.

In addition, not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with methylene blue. The cases of serotonin syndrome with methylene blue occurred in patients taking specific serotonergic psychiatric drugs, namely a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), or clomipramine. It is unclear at this time whether intravenous methylene blue administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk.

FDA will update the public when new information is available.

October 21 2011 - Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

[UPDATED 10/21/2011] The FDA updated information on the potential drug interaction between linezolid and serotonergic psychiatric medications. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome with linezolid occurred in patients taking specific serotonergic psychiatric drugs, namely a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). It is unclear at this time whether linezolid administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk.

FDA will update the public when new information is available.

 

October 20 2011 - Exenatide (Byetta by Lilly) has been approved by the FDA for use with insulin glargine.  Prescribing Information

October 20 2011 - Deferiprone (Ferriprox by ApoPharma USA) has been approved by the FDA to treat patients with iron overload due to blood transfusions in patients with thalassemia who had an inadequate response to prior chelation therapy. Prescribing Information

October 18 2011 - Atazanavir (Reyataz by Bristol–Myers Squibb) has new dosage and administration approved by the FDA.  Prescribing Information

October 14 2011 - The MedWatch September 2011 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm274280.htm
 

October 11 2011 - Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

BACKGROUND: Sprycel (dasatinib) is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

RECOMMENDATION: Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.

Read the Drug Safety Communication for additional information including a data summary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm275176.htm

 

October 10 2011 - Simvastatin-sitagliptin (Juvisync by Merck), has been approved by the FDA to treat diabetes and high cholesterol.  Prescribing Information

October 10 2011 - Tadalafil (Cialis by Lilly) has been approved by the FDA to treat the signs and symptoms of benign prostatic hyperplasia (BPH)and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously.  Prescribing Information

September 27 2011 - Eculizumab (Soliris by Alexion), has been approved by the FDA to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke. Prescribing Information

September 27 2011 - Infliximab (Remicade by Janssen Biotech), Inc. has been approved by the FDA for the treatment of moderately to severely active ulcerative colitis, or UC, in pediatric patients who have had an inadequate response to conventional therapy. Prescribing Information

September 22 2011 - Laureth-9 (Acelera by BioForm Medical) has been approved by the FDA to sclerose uncomplicated spider veins (varicose veins less than 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Prescribing Information

September 19 2011 - Denosumab (Prolia by Amgen) has been approved by the FDA as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer. Prescribing Information

September 15 2011 - Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.

BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which Zofran (ondansetron) may cause QT interval prolongation.

RECOMMENDATION: The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272041.htm

September 13 2011 - The MedWatch August 2011 Safety Labeling Changes posting includes 45 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

 

September 7 2011 - Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)

ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

BACKGROUND: The class of TNFα blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

RECOMMENDATION: The risks and the benefits of TNFα blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htm

 

September 1 2011 - Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. The revised label states that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.

The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

BACKGROUND: Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label. Dose reductions for Zometa are provided for patients with renal impairment.

RECOMMENDATIONS: Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Drug Safety Communication, including a Data Summary, and prescribing information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270464.htm

 

September 1 2011 - Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

ISSUE: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections have been revised to include information about type I hypersensitivity reactions which may include anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. In several cases, these reactions occurred after the first dose.

BACKGROUND: Saphris (asenapine maleate) is used to treat symptoms of schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Drug Safety Communication with Data Summary,  and prescribing information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270600.htm

 

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