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Drug News
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 2 3
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 1 1 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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