Archive
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 – Ondansetron (Zofran) IV
Ondansetron (Zofran) IV: Drug Safety Communication – QT prolongation
AUDIENCE: Oncology, Surgery, Gastroenterology
ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.
GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should exceed 16 mg. Information from the new clinical study will be included in the updated drug label.
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 will evaluate the final study results when available, and will work with GSK to explore an alternative single dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting in adults.
RECOMMENDATION: The new information on QT prolongation does not change any of the recommended oral dosing regimens for ondansetron. It also does not change the recommended lower dose intravenous dosing of ondansetron to prevent post-operative nausea and vomiting.
The use of a single 32 mg intravenous dose of ondansetron should be avoided. New information indicates that QT prolongation occurs in a dose-dependent manner, and specifically at a single intravenous dose of 32 mg.
Patients who may be at particular risk for QT prolongation with ondansentron are those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval
Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia) should be corrected prior to the infusion of ondansetron.
The lower dose intravenous regimen of 0.15 mg/kg every 4 hours for three doses may be used in adults with chemotherapy-induced nausea and vomiting. However, no single intravenous dose of ondansetron should exceed 16 mg due to the risk of QT prolongation.
The new information does not change any of the recommended oral dosing regimens for ondansetron, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product 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:
FDA MedWatch – ev3 Onyx Liquid Embolic System
ev3 Onyx Liquid Embolic System: Safety Communication – Risk of Catheter Entrapment
AUDIENCE: Neurology, Surgery
ISSUE: FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. The most serious complications include hemorrhage and death. Other complications include migration of the Onyx plug or catheter fragment to other parts of the body. Patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and Onyx plug, increasing their exposure to radiation.
The FDA approved changes to the physician and patient labeling that reflect the risks related to catheter entrapment. The labeling also includes recommendations to help minimize the risk of entrapment. Physicians should expect to see this labeling in new orders of Onyx.
BACKGROUND: The Onyx Liquid Embolic System (“Onyx”), manufactured by ev3, is a liquid material used to block blood flow in abnormally formed blood vessels in the brain, also know as brain arteriovenous malformations or brain AVMs, before their surgical removal. A catheter is used to deliver the Onyx liquid to blood vessels in the brain.
RECOMMENDATIONS: Catheter entrapment is unlikely to affect the physician’s ability to surgically remove the patient’s AVM. However, neither Onyx nor the catheter is intended to be long-term implants, and patients may need additional medical interventions to have the catheter removed if it becomes entrapped.
Neuro interventionalists should select patients carefully, after reviewing the most recent device labeling and instructions.
Onyx is only approved for use in patients who will undergo surgical removal of the treated brain AVM.
Onyx has not been tested or approved as a long-term implant.
Healthcare professionals should be prepared to treat serious complications associated with the use of Onyx and ensure that your facility is staffed and equipped to address these complications should they arise.
Read the FDA Safety Communication for additional information.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Onyx Liquid Embolic System, including a difficult to remove or entrapped (retained) catheter while using Onyx, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Please include the following information in your reports, if available:
Adverse event details (date adverse event occurred; complications that occurred, e.g. retained or plugged catheter, migration of Onyx plug, hemorrhage of the brain AVM; and the medical intervention required)
Type of Onyx used (e.g. Onyx 18 or Onyx 34)
Expiration dates of Onyx, delivery catheter and all accessories used
Model and size of catheter used with Onyx
Location in the anatomy where Onyx was used
Amount (distance) of reflux
Whether vessel was in vasospasm
Whether surgical resection is planned
Location in the pedicle being embolized where the catheter got stuck. For example, proximity to the origin of the pedicle vessel and proximity to the Onyx plug.
Whether additional medical therapies (e.g. antithrombotics) were needed
To report adverse events or side effects related to the use of this product:
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 safety communication, at:
FDA MedWatch – November 2009 Drug Safety Labeling Changes
The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug products with safety labeling changes to the following sections: BOXED WARNING, 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/ucm191946.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
• Actiq (fentanyl citrate)
• Adenocard (adenosine)
• Adenoscan (adenosine)
• Avandaryl (rosiglitazone maleate and glimepiride)
• Byetta (exenatide)
• Cimzia (certolizumab pegol)
• Cleocin HCL (clindamycin hydrochloride)
• Enbrel (etanercept)
• Humira (adalimumab)
• Lotensin (benazepril hydrochloride)
• Lotensin HCT (benazepril/hydrochlorothiazide)
• Lopressor (metoprolol tartrate)
• Norvir (ritonavir) capsule and solution
• Parnate (tranylcypromine sulfate)
• Plavix (clopidogrel bisulfate)
• Qualaquin (quinine sulfate)
• Rebetol (ribavirin), Soma (carisoprodol)
• Remicade (infliximab)
• Simponi (golimumab)
• Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
• Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
• Tekturna (aliskiren)
FDA MedWatch – July 2009 Drug Safety Labeling Changes
The MedWatch July 2009 Drug Safety Labeling Changes posting includes 38 drug products with safety labeling changes to the following sections: BOXED WARNING, 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.
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Chantix (varenicline), Wellbutrin (bupropion hydrochloride), Zyban (bupropion hydrochloride), Diabeta (glyburide), Lopid (gemfibrozil), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), Soliris (eculizumab)
FDA MedWatch – June 2009 Labeling Changes
The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections: BOXED WARNING, 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.
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections: Prometrium (progesterone), Reglan (metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR (carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (ceftriaxone sodium), Strattera (atomoxetine hydrochloride)
Vanderbilt HRPP News 