Recalls and Safety Alerts from the FDA
ForeCYTE Breast Health Test and Mammary Aspiration Cytol- ogy Test (MASCT)
Atossa Genetics Inc. initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address U.S. Food and Drug Administration (FDA) concerns about the current instructions for use (IFU), certain promotional claims used to market these devices, and the need for FDA clearance for certain changes made to the nipple aspirate fluid specimen collection process identified in the current IFU. To date, Atossa is unaware of any adverse incidents or injuries associated with the use of the ForeCYTE Breast Health Test, the MASCT device, or the processing method currently identified in the IFU.
Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall—Particulate Matter Found in Vials
Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013. No products were distributed out of state. For a detailed list of affected products visit
MedStream Programmable Infusion Pump and Refill Kits by Codman & Shurtleff: Class 1 Recall—Drug Over Infusion
FDA and Codman & Shurtleff, Inc., notified healthcare professionals of the class 1 recall of MedStream Programmable Pump and MedStream Refill Kit due to air in the pump reservoir, which may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and death.
Nature’s Pharmacy and Compounding Center Sterile Com- pounded Products: Recall—Lack of Sterility Assurance
Nature’s Pharmacy and Compounding Center of Asheville, NC, is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the consumer level. The product will be in the form of an injectable drug or an eye drop. The recall is being initiated due to concerns associated with quality control procedures that were observed during a recent FDA inspection and present a potential risk to sterility assurance.
Hematology/Oncology Approvals and Safety Notifications
Inclusig (Ponatinib): Drug Safety Communication—Increased Reports of Serious Blood Clots in Arteries and Veins
The FDA is investigating an increased frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) in patients taking the leukemia chemotherapy drug Iclusig (ponatinib). Data from clinical trials and postmarket adverse event reports show that serious adverse events have occurred in patients treated with Iclusig, including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and urgent surgical procedures to restore blood flow. The FDA is actively working to further evaluate these adverse events and will notify the public when more information is available.
ISMP Medication Safety Alert!
• November 14, 2013 (Volume 18, Issue 23): Management of overfill volume for chemotherapy is critical to ensure patients receive full doses of their medications. Healthcare organizations should develop standardized preparation methods for consistency.
• December 12, 2013 (Volume 18, Issue 25): There is confusion regarding the need to use 10-ml syringes for flushing and locking via vascular access devices, including implanted ports and peripherally inserted central catheter lines. Bard Access Systems is updating their information to state that, with the exception of a 1-ml prefilled syringe, and once patency is assured, medication administration with smaller diameter syringes can occur.
Changes in Safety Labeling
Arzerra (Ofatumumab) Injection
Changes to ofatumumab labeling include the following:
• Reactivation of hepatitis B virus (HBV) with some reports of fulminant hepatitis, hepatic failure, and death; all patients should be screened for HBV before starting treatment with ofatumumab.
• Tumor lysis syndrome can occur with ofatumumab.
• Progressive multifocal leukoencephalopathy (PML) resulting in death has occurred with ofatumumab. PML should be considered in patients with new onset of or changes in pre- existing neurological signs or symptoms.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm372685.htm
Tasigna (Nilotinib) Capsules
The following changes to nilotinib labeling have occurred:
• Avoid food 2 hours before and 1 hour after taking a dose of nilotinib.
• Electrolyte, calcium, and magnesium blood levels should be tested before initiating and periodically during treatment with nilotinib.
• Sudden deaths have occurred in 0.3% of chronic myeloid leukemia patients treated with nilotinib.
• Nilotinib can cause increases in serum lipase, and those patients with a history of pancreatitis may be at greater risk.
• Avoid administration with agents that are strong CYP3A4 inhibitors, or antiarrhythmic medications (including, but not limited to, amiodarone, disopyamide, procainamide, quinidine, and sotolol) and other medications that may prolong the QT interval. Therapy with nilotinib should be interrupted if treatment with any of these agents is started.
• Lower doses of nilotinib should be used in patients with mild to severe hepatic impairment due to increased nilotinib exposure.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm182234.htm
Gemcitabine Injection 38 mg/mL
The following change has been made to gemcitabine labeling:
Capillary leak syndrome (CLS) with severe consequences has been reported in patients receiving gemcitabine as a single agent or in combination with other chemotherapeutic agents. Discontinue gemcitabine if CLS develops during therapy.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm371309.htm
The following changes have been made to filgrastim labeling:
• Thrombocytopenia has been reported in patients receiving NEUPOGEN. Platelet counts should be monitored closely.
• Information on Amgen’s Lactation Surveillance Program has been added.
• Splenomegaly has been added to the adverse reaction section according to postmarketing experience.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm219032.htm
Alimta (Pemetrexed for Injection)
The following change has been made to pemetrexed labeling:
Reports of immune mediated hemolytic anemia have occurred with pemetrexed used as a single agent or in combination with other agents.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm371329.htm
Gleevec (Imatinib Mesylate) Tablets
The following change has been made to imatinib mesylate labeling:
Gleevec can cause fetal harm when administered to a pregnant woman.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm255333.htm
Lupron Depot (Leuprolide Acetate for Depot Suspension) and Lupaneta Pack (Leuprolide Acetate for Depot Suspension; Nor- ethindrone Acetate Tablets)
The following labeling change has been made:
There have been postmarketing reports of convulsions in patients on leuprolide acetate therapy. These included patients with and without concurrent medications and comorbid conditions.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm374019.htm
Zaltrap (Ziv-Aflibercept) Injection
The following labeling change has been made to ziv-aflibercept:
Monitor proteinuria by urine dipstick analysis or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria during Zaltrap therapy. Patients with a dipstick of =2+ for protein or a UPCR greater than 1 should undergo a 24-hour urine collection.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm374591.htm
Abraxane Injectable Suspension (Paclitaxel Protein-Bound Particles [Albumin-Bound])
The following labeling change has been made to Abraxane:
Cardiovascular: There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with Abraxane. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm359951.htm
The following labeling changes have been made to sorafenib:
• Osteonecrosis of the jaw.
• Impairment of thyroid-stimulating hormone suppression in differentiated thyroid carcinoma; Sorafenib impairs exogenous thyroid suppression.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm280363.htm
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm319233.htm
Revlimid (Lenalidomide) Capsules
The following labeling change has been made to lenalidomide:
Lenalidomide should not be used to treat people who have chronic lymphocytic leukemia unless they are participants in a controlled clinical trial, due to increased mortality risk.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm299519.htm
Xalkori (Crizotinib) Capsules
The following labeling changes have occurred with crizotininb:
• Drug-induced hepatotoxicity with fatal outcome occurred in two (0.2%) of the 1,225 patients treated with crizotinib across three main clinical trials.
• Severe, life-threatening, or fatal interstitial lung disease/pneumonitis can occur in patients treated with crizotinib.
• QTc prolongation can occur in patients treated with crizotinib.
• Symptomatic bradycardia can occur in patients receiving crizotinib.
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm295722.htm
Votrient (Pazopanib) Tablets
The following change has been made to the adverse reactions section of pazopanib labeling:
Arthralgia, muscle spasms
www.fda.gov/ Safety/MedWatch/ SafetyInformation/ucm303649.htm