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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Out of an abundance of caution, SunOpta Inc’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of certain frozen organic dark sweet pitted cherry products due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.


FDA is announcing a voluntary recall of all liquid products manufactured by PharmaTech, and distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, due to possible Burkholderia cepacia contamination. These products, including various drugs and dietary supplements intended for use in infants and children, were distributed nationwide. See the recall announcement for a complete list of recalled products with photos.

Patients, pharmacies, and healthcare facilities that have the recalled product on hand should stop using and dispensing them immediately.

Consumers with questions regarding this recall can contact the companies at the numbers below:

•Leader Customer Support: at 1-800-200-6313, option #1, Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m.– 5 p.m. EST

•Rugby Laboratories/Major Pharmaceuticals Customer Support: 1-800-645-2158, Monday through Friday 8 a.m. – 8 p.m. EST

For more information, please visit: PharmaTech Recall


Saving Lives. Protecting People. TM

Zika Updates
August 11, 2017

Cases At-A-Glance

Pregnant Women with Any Lab Evidence of Zika Virus Infection*

  • US States and DC: 2,086
  • US Territories: 4,341

*Source: Pregnancy Registries as of July 25, 2017

Zika Virus Disease Cases Reported to 

  • US States and DC: 5,413
  • US Territories: 37,007

*Source: ArboNET as of August 9, 2017

Read More

What's New

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Zika can spread through sex


Take steps to protect yourself and your partner.

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FDA Approves BESPONSA (Inotuzumab Ozogamicin) for Adults with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved BESPONSA (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Hepatotoxicity, including fatal and life-threatening veno-occlusive disease (VOD) occurred in patients with relapsed or refractory ALL who received BESPONSA. The risk of VOD was greater in patients who underwent hematopoietic stem cell transplant (HSCT) after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.

There was higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate.

Administer BESPONSA with caution in patients who have a history of or predisposition for QTc prolongation, who are taking drugs that prolong QT interval, and in patients with electrolyte disturbances.

Approved Recommended Dosage


  • Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to all infusions. For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of less than or equal to 10,000/mm3 is recommended prior to the first dose.

Cycle 1:

  • The recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 is 21 days in duration, but may be extended to 28 days (i.e., 7-day treatment-free interval starting on Day 21) if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.

Subsequent Cycles:

  • In patients who achieve a CR or CRi, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 28 days in duration.
  • In patients who do not achieve a CR or CRi, the recommended total dose of BESPONSA is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 28 days in duration. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.
  • For patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for those patients who do not achieve CR or CRi and minimal residual disease negativity after 2 cycles. 
  • For patients not proceeding to HSCT, additional cycles of treatment, up to a maximum of 6 cycles, may be administered.

Dosage Modifications:

  • Clinical monitoring recommendations and dosage modifications for toxicities with BESPONSA, including hematological, hepatic and other non-hematological, and infusion-related reactions, are described in the full prescribing information linked below.

Mechanism of Action (MOA), General Pharmacokinetics (PK), and Pharmacodynamics (PD) 

  • MOA: Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate. N-acetyl-gamma-calicheamicin is a cytotoxic agent that is covalently attached to the antibody via a linker.
  • General PK: PK of inotuzumab ozogamicin was characterized by a 2-compartment model with linear and time-dependent clearance components. Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was predicted by Cycle 4 (steady-state).
  • Distribution: N-acetyl-gamma-calicheamicin dimethylhydrazide is approximately 97% bound to human plasma proteins in vitro.
  • Elimination: The clearance of inotuzumab ozogamicin at steady state was 0.03 L/h. The terminal half-life was 12.3 days.
  • Metabolism: N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolized via nonenzymatic reduction.
  • Cardiac Electrophysiology: In patients with relapsed or refractory ALL, QTcF ≥ 60 msec from baseline were observed in 3% of patients in the BESPONSA arm and 2% of patients in the Investigator’s choice of chemotherapy arm. The highest mean for QTcF was 15.3 msec and observed at the beginning of Cycle 4 in the BESPONSA arm.
Drug Interactions 

Discontinue drugs known to prolong QTc or use alternative drugs that do not prolong QTc interval or induce Torsades de Pointes. Concomitant use with BESPONSA may increase the risk of QTc interval prolongation. When it is not feasible to avoid concomitant use of drugs known to prolong QTc, monitor as described in the full prescribing information linked below.

Use in Specific Populations

Body surface area was found to significantly affect inotuzumab ozogamicin disposition.

Age (18-92 years), sex, race, or renal impairment (15-89 mL/min) do not have a clinically significant effect on the pharmacokinetics of inotuzumab ozogamicin. The pharmacokinetics in patients with end stage renal disease with or without hemodialysis is unknown.

Hepatic impairment: 
No adjustment to the BESPONSA starting dose is required in patients with total bilirubin ≤ 1.5 × ULN and AST/ALT ≤ 2.5 × ULN. There is limited safety information available in patients with total bilirubin > 1.5 × ULN and/or AST/ALT > 2.5 × ULN prior to dosing. Interrupt dosing until recovery of total bilirubin to ≤ 1.5 × ULN and AST/ALT ≤ 2.5 × ULN prior to each dose unless due to Gilbert’s syndrome or hemolysis. Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN.

Efficacy and Safety

The efficacy and safety of BESPONSA were demonstrated in a randomized, open label, international, multicenter study in patients with relapsed or refractory ALL. Efficacy of BESPONSA was established on the basis of achieving CR, the duration of CR, and attainment of minimal residual disease negativity. Additional information regarding the efficacy trial can be found in the full prescribing information linked below. The most common (≥ 20%) adverse reactions are thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.

Full prescribing information is available at

Visit Drugs@FDA at for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

We always welcome your thoughts regarding the format, content, and utility of the communication. Comments may be sent via email to

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.


August 21, 2017

New This Week

Guideline Summaries

American Society for Radiation Oncology

American Society of Clinical Oncology


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Personalize NGC to accommodate your specific interests by Creating a Free Account. You can save and compare your favorite guideline summaries, and receive e-mail alerts on new and updated content. Learn more.

Coming Soon

New & Updated American College of Radiology (ACR) Appropriateness Criteria Guidelines.

Health Awareness Topics: August 2017

How to Participate

Submit Guidelines: Visit our Submit Guidelines page for information on how to submit your organization's guidelines.

Suggest a Guideline for Possible Inclusion: Submit your suggestions for evidence-based clinical practice guidelines that you would like to see included in NGC.

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Look for Quality Measures in AHRQ's National Quality Measures Clearinghouse (NQMC).


FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA Reauthorization Act (FDARA) signed into law

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which revises and extends FDA’s user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar products. Reauthorization of these user-fee programs allows the agency to continue fulfilling its mission of protecting and promoting public health. It also provides FDA with the necessary resources to increase regulatory efficiency and speed the availability of innovative, safe and effective medical products.

To learn more, please visit: Food and Drug Administration Reauthorization Act (FDARA).


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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

FDA today announced an upcoming meeting of the Pediatric Advisory Committee that will focus on the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients, including current treatment practices and benefit-risk considerations. The panel of independent experts will provide valuable input to help inform the agency’s decision-making processes related to these medications.

It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions. This is an area that the agency is continuing to evaluate. As part of these efforts, the FDA announced required changes in April 2017 to the labeling of prescription codeine products in order to help better protect children from serious risks associated with these opioid medications, including life-threatening respiratory depression and death. Those changes include adding a contraindication to drug labels alerting that codeine should not be used for any reason, including treatment of cough, in children younger than 12 years. 

The FDA has also provided tips for consumers on how to safely treat a child’s cold as most young children do not need medicines to treat a cough or cold. Caregivers should read labels on non-prescription cough and cold products that may be sold over the counter as these products may contain codeine or may not be appropriate for young children. The FDA is also funding research to develop comprehensive, consumer-centered approaches on best practices for the safe use of pediatric cough and cold medications generally – not just those that contain an opioid.

For more information, please visit: Children’s Prescription Opioid Cough Medications.

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Pregnancy Research

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By: Pamela E. Scott, Ph.D.
When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what to do about prescription drugs is a more complicated topic.
There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical practice must prescribe needed medicines to pregnant women to treat a variety of illnesses and conditions such as diabetes, high blood pressure or even something as simple as a dental infection. 

Indeed, about half of the 6.3 million women who are pregnant every year take at least one medication, and prescription use is on the rise, up by more than 60 percent from 1976 through 2008.

More information is clearly needed. The 21st Century Cures Act, which was enacted in 2016, established a task force to consider what is being done to identify and address gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. Within 18 months after it is established, the task force will develop a report to Congress with specific recommendations for addressing the issues identified. The Office of Women’s Health (OWH) is leading FDA’s activities for the task force. My colleagues at OWH will be working with FDA’s Centers to promote dialogue and research collaboration. We look forward to hearing from our public and private partners at the Task Force's two-day public meeting, which begins today. Continue reading 

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Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumpsmanufactured before June 30, 2013 due to the risk of a valve failure which prevents the balloon from inflating and deflating properly. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.

On June 30, 2013, Datascope Corp./MAQUET implemented a design change to prevent this problem, but not all devices manufactured prior to June 13, 2013 have been serviced and upgraded.





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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.

The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.

Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.

For more information, please visit: Mavyret.


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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions. The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx, located in Irvine, California. Hypersensitivity reactions to intravenous (IV) products containing polyethylene glycol castor oil have been reported in the literature and are the subject of warnings for a number of FDA-approved drugs.

FDA’s investigation into the adverse events associated with ImprimisRx’s curcumin emulsion product for injection highlights some of the risks associated with compounded drugs, particularly those that use non-pharmaceutical grade components and ingredients lacking a USP monograph.

Stay up-to-date via our new webpage on Compounding Risk Alerts.


Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

AUDIENCE: Consumers, Health Care Professionals

ISSUE: The U.S. Food and Drug Administration is warning parents and caregivers not to use “Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine” due to the risk of lead poisoning.

FDA has not reviewed this product for safety or effectiveness. Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system. In children, chronic exposure to lead—even at low levels—is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

BACKGROUND: This product is sold online and manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. Individuals have also mailed or brought the product into the United States. “Balguti Kesaria Ayurvedic Medicine” is used with infants and children for a variety of conditions including rickets, cough and cold, worms and dentition (teething).

FDA initially learned of this risk from the North Carolina Division of Public Health after the product was tested and found to contain high levels of lead. FDA was also notified by the Michigan Department of Health and Human Services of high levels of lead in two children who were given this product. Michigan’s testing also found high levels of lead in the product. To date, FDA has received one adverse event report of high levels of lead and developmental delays in a child who was given this product.

RECOMMENDATION: Anyone who is using this product or giving it to a child should stop immediately and consult a health care professional.

Health care professionals and consumers are encouraged to report any adverse events potentially related to “Balguti Kesaria Ayurvedic Medicine”or any other alternative medicines to FDA’s MedWatch Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • 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.
Link to MedWatch Safety Alert and CDER Statement:



Commonwealth Dairy of Brattleboro, VT is recalling Friendly Farms Key Lime Crunch Tilts because it may contain undeclared almond pieces. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.



The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). AMPT Coffee also contains undeclared milk.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.


ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.



Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

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Oscor Inc. is recalling specific lots of the ATAR Extension Cables due to a risk of the extension cables separating from the connectors during use.

Detachment of the extension cable and connectors can result in a delay and/or failure of cardiac pacing therapy for the patient. As the failure occurs without warning, it is possible that pacing-dependent patients may suddenly be left unpaced without adequate warning to their caregivers to quickly exchange the defective cable. Sudden pacing delay and/or failure may result in immediate and serious adverse health consequences, including death.


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"My people are destroyed for lack of knowledge...."  Hosea 4:6-7