FDA MedWatch – Ampyra (dalfampridine): Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients
Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients
AUDIENCE: Neurology, Internal Medicine
ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations.
BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.
RECOMMENDATION: FDA reminds health care professionals that there are age-related decreases in renal function, and mild renal impairment is common after age 50, even when serum creatinine is normal. Renal function should be assessed by estimating creatinine clearance. Ampyra should not be used in patients with a history of seizures or who have moderate to severe renal (kidney) impairment (measured as creatinine clearance [CrCl] less than or equal to 50 mL/min).
Additional information for Patients includes:
Tell your health care professional if you have kidney problems.
Your health care professional should order blood tests periodically to evaluate your kidney function.
Do not take Ampyra if you have ever had a seizure.
Ampyra tablets should be taken whole and not divided, crushed, chewed, or dissolved.
Do not take double or extra doses of Ampyra if a dose is missed. Side effects, including seizures, are more frequent at higher doses.
Additional information for Health Care Professionals includes:
Ampyra is contraindicated in patients with a history of seizures or with moderate to severe renal impairment (CrCl < 50 mL/min).
The potential benefits of Ampyra treatment should be carefully considered against the risk of seizures before using Ampyra in patients with mild renal impairment (CrCl 51-80 mL/min).
A patient’s CrCl (calculated using the Cockroft-Gault equation) should be known before initiating Ampyra treatment and monitored at least annually whileAmpyra treatment continues, even when serum creatinine levels appear to be normal.
Tell patients they should not take double or extra doses of Ampyra if a dose is missed. Adverse effects, including seizures, are more frequent at higherdoses.
Ampyra should be discontinued permanently if a seizure occurs.
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.htm1
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 at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm313055.htm
FDA MedWatch – CareFusion EnVe Ventilators
CareFusion EnVe Ventilators: Class I Recall – Leak In Patient Breathing Circuit or System
AUDIENCE: Critical Care Medicine, Risk Manager
ISSUE: FDA notified healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators manufactured from December, 2010 through January, 2012 and distributed from December, 2010 through May, 2012. A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. This product may cause serious adverse health consequences, including death.
BACKGROUND: The CareFusion EnVe ventilator is intended for continuous breathing support for the care of newborns through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care facilities. The firm sent an Urgent Product Recall letter to their customers.
RECOMMENDATION: If ventilation resumes after an intermittent leak and the audible alarm stops, the firm directs users to clear the alarm indicator on the ventilator display by entering the Alarm Messages tab and pushing the alarm reset to clear the display. If the ventilator has a continuous leak and normal ventilation does not resume, the firm directs users to provide an alternate method of ventilation to the patient. The firm instructs users to constantly monitor ventilator-dependent patients to ensure that if a malfunction occurs, alternate ventilation can be provided.
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 Recall Notice, at:
FDA MedWatch – Hospira Injectable Drug Products
Hospira Injectable Drug Products: Recall – Visible Particulates from Defective Glass Vials
Including certain lots of the following products:
carboplatin
cytarabine
paclitaxel
methotrexate
AUDIENCE: Risk Manager
ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of certain injectable drug products, due to visible particles embedded in the glass located at the neck of the vial. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.
See the Press Release for a listing of affected product lot numbers and expiration dates.
BACKGROUND: These products were distributed nationwide to wholesalers and direct customers. Hospira completed an investigation and attributed the root cause to a supplier glass defect. Hospira is arranging for return/replacement etc. of all recalled products. Formal recall letters have been distributed within the US along with notification to safety organizations.
RECOMMENDATION: Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-628-0734 between the hours of 8am to 5pm EDT, Monday through Friday, to arrange for the return of the product.
Read the MedWatch safety alert, including a link to the Press Release, at:
FDA MedWatch – Manquet Medical Systems USA FLOW-i Anesthesia System
Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall – Device Field Correction
AUDIENCE: Risk Manager
ISSUE: FDA notified healthcare professionals of a Class I Recall of the Maquet Medical Systems USA FLOW-i Anesthesia System (software). A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the “on” or “off” position but remains in between the two positions. Use of this product may cause serious adverse health consequences, including death.
The FLOW-i Anesthesia System was distributed from May 9, 2010 through December 29, 2011. See the Recall Notice for a listing of affected Model and Serial Numbers.
BACKGROUND: The FLOW-i Anesthesia System is intended to administer anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as supporting patients with a limited ability to breathe.
RECOMMENDATION: On February 20, 2012, the firm sent its customers an Urgent Device Field Correction notice. The firm informed their customers that their Maquet Service Representative will upgrade the software in their FLOW-i Anesthesia System to the current version and also provide them with the corresponding user manual.
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 Recall Notice, at:
FDA MedWatch – Alere Triage Diagnostic Tests (Multiple Tests)
Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall – Potential for Significantly Decreased Precision
Including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer
AUDIENCE: Laboratory, Cardiology, Pulmonology, Risk Manager
ISSUE: FDA notified healthcare professionals of a Class I Recall of Alere Triage products. Identified lots may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. Certain lots affected have an increased frequency of Troponin I results >0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing.
There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results. This product may cause serious adverse health consequences, including death.
These products were manufactured from 06/12/2011 to 04/08/2012. Distributed from 09/08/2011 to 06/05/2012. 98,100 test kits have the potential to be defective. See the Recall Notice for listings of identified Lot Numbers.
BACKGROUND: Alere Triage is a rapid diagnostic test system comprised of a meter and various test devices that aid in the diagnosis of diseases and health conditions including heart failure and myocardial infarction as well as aid in assessing patients for pulmonary embolism.
RECOMMENDATION: The firm requests customers to immediately discontinue all use and discard any remaining product and to use unaffected lots or alternative methods for measuring these analytes. There may not currently be sufficient unaffected product to supply the product demand for all laboratories. The duration of supply disruptions are not known.
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 Recall Notice, at:
FDA MedWatch – June 2012 Safety Labeling Changes includes 35 products with revisions to Prescribing Information
The MedWatch June 2012 Safety Labeling Changes posting includes 35 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/ucm309380.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:
Avodart (dutasteride)
Bepreve (bepotastine besilate) 1.5% ophthalmic
CellCept (mycophenolate mofetil)
CellCept (mycophenolate mofetil hydrochloride)
Estraderm (estradiol) transdermal
Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
Incivek (telaprevir)
Jalyn (dutasteride and tamsulosin HCL)
Methergine (methylergonovine maleate)
Myfortic (mycophenolic acid)
Noxafil (posaconazole)
Prezista (darunavir)
Prinivil (lisinopril) tablets and
Prinzide(lisinopril/hydrochlorothiazide)
Privigen Immune Globulin Intravenous (Human) 10%
Stelara (ustekinumab)
Strattera (atomoxetine hydrochloride)
Sustiva (efavirenz)
Vesicare (solifenacin succinate)
Zithromax (azithromycin)
FDA MedWatch – iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements
iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder Dietary Supplements: Recall – Possible Salmonella Contamination
AUDIENCE: Consumer
ISSUE: Sedona Labs today announced that its supplier of Galactooligosaccharide (GOS) has recalled this ingredient due to a possible Salmonella contamination. As a result,Sedona Labs is now voluntarily recalling certain lots of iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder distributed between 3/16/2011 and 5/3/2012. See the firm press release for the lots with their corresponding UPC codes that are included in the recall.
BACKGROUND: Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
RECOMMENDATION: Consumers possessing these products should immediately discontinue their use. To date, no illnesses have been reported in connection with the iFlora Kids Multi-Probiotic or iFlora 4-Kids Powder.
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 firm Press Release at:
FDA MedWatch – CareFusion Airlife Infant Breathing Circuit
CareFusion Airlife Infant Breathing Circuit: Class I Recall – Potential for Leak in Closed Ventilation System
AUDIENCE: Anesthesiology, Risk Manager
ISSUE: FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk that the Y-adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. These products may cause serious adverse health consequences, including death. The recalled products were distributed from July 1, 2010 through May 7, 2012.
See the Recall Notice for a listing of affected lot numbers.
BACKGROUND: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
RECOMMENDATION: On May 29, 2012, the firm sent an Urgent Recall Notice to customers and distributors. The distributors were requested to immediately destroy any affected product in-stock at their facilities and to cease distributing these products. They were also requested to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk. CareFusion is requesting that customers destroy all affected product or return any unused product to the distributor.
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
FDA MedWatch – Leucovorin Calcium Injection (Bedford Laboratories)
Leucovorin Calcium Injection (Bedford Laboratories): Recall – Visible Particulate Matter
AUDIENCE: Pharmacy, Risk Manager, Oncology
ISSUE: Bedford Laboratories issued a nationwide recall of three lots of Leucovorin Calcium Injection, due to the discovery of visible crystalline particulate matter in a small number of vials. To date, there have been no reports of any adverse events for the lots being recalled. The particulate matter has been identified as active drug substance and not foreign material or contamination. Particulate matter has been recognized as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death.
See the Press Release for a listing of lot numbers affected. The shipping dates for these recalled lots were between January 2011 and June 2011.
BACKGROUND: Leucovorin Calcium rescue is indicated after high‐dose methotrexate therapy in osteosarcoma. Leucovorin Calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists; the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible; and for use in combination with 5‐fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.
RECOMMENDATION: Healthcare practitioners who had received the lot were instructed not to use the product and immediately quarantine it for return. As stated in the Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”
Read the MedWatch safety alert, including a link to the Press Release, at:
FDA MedWatch – Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator
Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection
AUDIENCE: Risk Manager, Surgery, Infectious Disease
ISSUE: An FDA review of ASP data showed that the Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout the indicated 15-month shelf life. After reviewing additional ASP data, the FDA believes that the product may be used with a 6-month shelf life.
BACKGROUND: The Sterrad Cyclesure 24 Biological Indicator is a product used periodically to monitor and confirm the microbicidal effectiveness of the sterilization process in Sterrad sterilizers. A biological indicator is used, in conjunction with other methods, to monitor sterilization systems.
Sterrad sterilizers are used for devices that must be sterilized at low temperatures, such as multiple single-channel flexible endoscopes, cameras, some rigid scopes, light cords, batteries, and power drills.
ASP’s Sterrad Cyclesure 24 Biological Indicator is the only biological indicator that can be used with the Sterrad sterilizer. Biological indicators from other manufacturers are not designed for this use and have not been cleared by the Food and Drug Administration (FDA) for use in Sterrad sterilizers.
RECOMMENDATIONS:
If your facility has purchased Sterrad Cyclesure 24 Biological Indicators and product remains on hand, a new expiration date can be calculated as follows: [Printed Expiration date (minus) 9 months = new expiration date].
Manually re-label the non-expired product cases with the newly calculated expiration date.
Use an alternative low-temperature sterilizer, if available. In order to conserve the amount of non-expired product available in your facility, only use low-temperature sterilization for those items that cannot be sterilized using other methods.
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.
Please include the following information in your reports, if available:
Adverse event details (date adverse event occurred, nature of the event)
Expiration date and/or lot number listed on the Sterrad Cyclesure 24 Biological Indicators
Read the FDA Safety Communication at:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310549.htm
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