FDA RECALL/CDC

FDA RECALLS

08/31/2016 07:42 PM EDT
Bimbo Bakeries USA, Inc. has initiated a voluntary recall of Entenmann’s Little Bites Fudge Brownies (5 pack), Chocolate Chip Muffins (5 pack and 10 pack boxes)and Variety Pack (20 pack) due to the presence of small pieces of plastic caused by a manufacturing failure at a contract manufacturer’s bakery in Illinois.

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


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


A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, we are adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines.

Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Unresponsiveness means that the person doesn’t answer or react normally or you can’t wake them up. Talk with your health care professional if you have questions or concerns about taking opioids or benzodiazepines (see List of Prescription Opioid Pain and Cough Medicines, and List of Benzodiazepines and Other CNS Depressants).

For more information, please visit: opioids and benzodiazepines.


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  • Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication – FDA Requiring Boxed Warning About Serious Risks and Death

    AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice

    ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.  Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.

    FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

    FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available. 

    BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.

    RECOMMENDATION: Health care professionals should limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate.  If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect.  Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms.  Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.

    Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. 

    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:

    Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518710.htm


09/01/2016 10:45 AM EDT
Magic Gourmet Trading Inc. of Millbrae, CA is recalling all Koi Palace Mooncake products purchased in August 2016 because these items do not contain proper labeling of ingredients and possible allergens. Mooncake products manufactured by Magic Gourmet contain possible allergens such as wheat, gluten, eggs, milk, peanuts, pine nuts, almonds, walnuts, and/or sesame.

VASCU-GUARD Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers – Potential Risk of Severe Bleeding and Hematomas

AUDIENCE: Surgery, Risk Manager

ISSUE: The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery. The device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.

The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death. After CEA surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.

BACKGROUND: The Vascu-Guard patch is intended for use in peripheral vascular reconstruction including carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

RECOMMENDATION: The FDA recommends that health care providers:

  • Discuss with your patients all available treatment options, including the risks and benefits of each, before deciding the best treatment approach.
  • Until FDA completes its investigation of the adverse events reported following CEA surgery, consider the following actions if using this device:
    • Employ heightened post-operative vigilance on the part of the patient and physician for signs of early bleeding (e.g., neck swelling, difficulty breathing).
    • Follow all manufacturer instructions for patch preparation.

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:

Read the MedWatch safety alert, including a link to the Letter to Healthcare Providers, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518852.htm


Mass Spectrometers by Sciex: Safety Communication – Incorrect Assignment of Test Results

Including:

Sciex API 3200 LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500 LC/MS/MS System, and the QTRAP 4500 LC/MS/MS equipped with:

  • the Analyst Software Versions 1.6.1 and 1.6.2, and
  • the MultiQuant Software Versions 3.0, 3.0.1, and 3.0.2.

AUDIENCE: Risk Manager, Laboratory

ISSUE: The FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed. Sciex notified the FDA that, under certain conditions, the defect in the software versions identified above may lead the devices to display results that do not match the specimens tested. This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices. A potential inaccurate clinical diagnosis or treatment decision may lead patients to experience serious adverse health consequences.

The mass spectrometers manufactured by Sciex are medical devices specified either for clinical diagnostic use or for research use only (RUO). RUO devices are typically in a development stage and must be labeled “For Research Use Only. Not for use in diagnostic procedures.”

The company has sent Urgent Medical Device Correction Letters and issued two voluntary recalls for the mass spectrometers for clinical use. However, there may be customers of the RUO version of the mass spectrometers that are using them for clinical purposes. Since Sciex has not notified its customers of the RUO version about the issues associated with the software defect in the instruments, we are concerned that these customers, which include clinical laboratories, may be unaware of the issue and its potential impact on results generated by the device.

BACKGROUND: Mass spectrometers are devices used in lab settings to identify inorganic or organic compounds (e.g. lead, mercury, drugs, proteins, and peptides) in human specimens. The devices separate isotopes, molecules, and molecular fragments according to their mass through electric and magnetic fields. Health care professionals may use the results to aid in their clinical diagnosis or to help evaluate possible treatment decisions.

RECOMMENDATION: FDA recommends the following:

  • Determine if your facility owns and uses one of the mass spectrometers equipped with the software listed above;
  • Contact Sciex for necessary software corrections; and
  • If necessary, laboratories should follow CLIA requirements to investigate and take appropriate corrective action when errors have been known, or are suspected to have occurred.

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:

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518907.htm


CDC

MMWR Surveillance Summaries
Vol. 65, No. SS-11
September 2, 2016
PDF

In this report

National Estimates of Marijuana Use and Related Indicators — National Survey on Drug Use and Health, United States, 2002–2014
Alejandro Azofeifa, DDS; Margaret E. Mattson, PhD; Gillian Schauer, PhD; et al.
MMWR Surveill Summ 2016;65:1–28

Marijuana is the most commonly used illicit drug in the United States. In 2013, 7.5% (19.8 million) of the U.S. population aged =12 years reported using marijuana during the preceding month. Because of certain state-level policies that have legalized marijuana for medical or recreational use, population-based data on marijuana use and other related indicators are needed to help monitor behavioral health changes. This report describes national trends for prevalence of marijuana use; initiation; perception of harm risk, approval, and attitudes; perception of availability and mode of acquisition; dependence and abuse; and perception of legal penalty for marijuana possession.


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Revelation 19:16 On his robe and on his thigh he has this name written: KING OF KINGS AND LORD OF LORDS. This blog is to present Up To Date Prophetic News. My prayer is that this blog will bring others to know Jesus as their Savior if they do not know him the King of Kings and Lord of Lords.

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