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Post Info TOPIC: FDA and CDC 3/24/2015
ed11563


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FDA and CDC 3/24/2015
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From the FDA and CDC

 

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Do You Know What 3 Questions Can Help Protect Older Adults from Falls?

 

One in three older adults falls each year, yet less than half tell their health care provider. A new CDC/Medscape video commentary with CDC’s Dr. Grant Baldwin aims to help start this important conversation.

The video, part of CDC’s STEADI initiative, highlights three questions that health care providers can integrate into routine office visits with patients 65 and older:

  1. Have you fallen in the past year?
  2. Do you feel unsteady when standing or walking?
  3. Do you worry about falling?

Using the tools in CDC’s STEADI initiative, the video then guides health care providers on screening, assessments, and proven interventions, such as:

  • Reviewing medications to ensure appropriate geriatric doses and reducing fall risk-increasing drugs.
  • Recommending Vitamin D supplements.

Watch the Medscape Video CDC Expert Commentary: Are You Asking Older Adult Patients the Right Questions? (free Medscape login required)

Why This Is Important

A fall among an older adult can lead to injuries that reduce mobility, limit social interactions, decrease physical fitness, lower quality of life, and increase the risk of early death. Through STEADI, CDC is working to educate patients and health care providers about how to help keep older adults safe from falls, so they can stay healthy, active, and independent longer.

Spread the Word

New CDC/Medscape Video highlights 3 questions that health care providers should ask every patient 65 and older. http://www.medscape.com/viewarticle/841020 #WHCoA

Learn More

 

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Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems

AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient

ISSUE: FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) did a review of mammograms performed by the Richard D. Adelman, M.D., Family Medicine practice between August 25, 2012, and August 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility's accreditation on November 5, 2014. On November 18, 2014, the FDA required the facility to notify all patients who received mammograms at its facility any time after August 24, 2012 about these problems, and to stop performing mammography.

This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at an Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up. Patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D, Family Medicine practice.

BACKGROUND: Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States.  This facility did not meet standards for mammography quality under the Act. The facility may not perform mammography due to the revocation of its accreditation by the ACR and its MQSA certification being no longer in effect until the accreditation is reinstated.

RECOMMENDATION: The FDA recommends the following for patients who had a mammogram at Richard D. Adelman M.D., Family Medicine practice any time after August 24, 2012:

  • If you have had a more recent mammogram at an MQSA-certified facility since then, you should follow the recommendations from that facility.
  • If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines:
  • Consider requesting your mammogram and copies of your medical reports from Richard D. Adelman, M.D, Family Medicine practice and have your mammogram reviewed at an MQSA-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed. A database of MQSA-certified facilities in your area is available online or by calling the National Cancer Institute's (NCI) information number at 1-800-422-6237.
  • If you need a repeat mammogram and your health insurance will not pay for it, you can call the NCI information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that provide free or low-cost mammograms.
  • If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439723.htm

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Supervalu Inc. Issues Allergy Alert on Undeclared Peanuts in Product

03/24/2015 01:30 PM EDT

 

Supervalu Inc. of Eden Prairie, Minn. is recalling Essential Everyday Chocolate Covered Raisins because the product may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

 

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Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

 

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Giant Eagle Voluntarily Recalls Little Italy Paninis Due to an Undeclared Egg Allergen

03/24/2015 12:46 PM EDT

 

All lots of Giant Eagle brand Little Italy Paninis, prepared and sold individually from the Prepared Foods department inside Giant Eagle and Market District supermarkets through March 23, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared egg allergen. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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Giant Eagle Voluntarily Recalls Japanese Breaded Cod Fillets Due to an Undeclared Soy Allergen

03/24/2015 12:49 PM EDT

 

All lots of Giant Eagle brand Japanese Breaded Cod Fillets, prepared and sold individually from the Seafood department inside Giant Eagle and Market District supermarkets through March 23, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared soy allergen. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

 

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Carmel Food Group Recalls Rising Moon Organics Frozen Ravioli Due to Possible Health Risk

03/24/2015 10:15 AM EDT

 

Hayward, CA. Carmel Food Group today issued a voluntary recall of certain Rising Moon Organics frozen Ravioli items, because of possible presence of Listeria monocytogenes.

 

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Everyone Has a Role in Stopping Youth Violence

National Youth Violence Prevention Week (March 23-27, 2015) is a time to show youth, parents, educators, and community leaders that youth violence is not an inevitable part of growing up. Youth violence can be prevented.

Help others be a positive influence on young people while stopping youth violence before it starts.

What You Need to Know

  • More than 547,000 young people, ages 10 to 24, are treated in emergency departments each year for injuries from violence-related physical assaults. On average, 12 young people are victims of homicide each day in the United States.
  • Prevention strategies that are proving effective include school programs designed to benefit all youth by changing how they think about violence and by building skills to resolve problems.
  • Preventing Youth Violence: Opportunities for Action provides action steps for everyone to be part of the solution.

 

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Blue Bell Ice Cream Recalls 3 oz. Institutional/Food Service Ice Cream Cups – Chocolate, Strawberry, Vanilla (Tab Lid) – Because of Possible Health Risk

03/23/2015 09:51 PM EDT

 

Blue Bell Ice Cream of Brenham, Texas, is recalling three 3 oz. institutional/food service ice cream cups- chocolate, strawberry and vanilla with tab lids because they have 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.

 

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more to follow ...

 

 

 

 

 

 

 

 

 

 

 

 



__________________

The Principle of Least Interest: He who cares least about a relationship, controls it.

Always misinterpret when you can.
ed11563


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Part two for today:

 

 

Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

AUDIENCE: Psychiatry, Pharmacy, Patient

ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.

BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.

RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.

Health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy (REMS) requirements and current label recommendations. Notable requirements of the REMS include:

  • For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program.
  • Zyprexa Relprevv injections must be administered at a REMS-certified health care facility with ready access to emergency response services.
  • Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours following an intramuscular injection.
  • Patients receiving Zyprexa Relprevv must be accompanied to their destination from the health care facility.

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
  • 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/ucm439472.htm

 

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Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug

AUDIENCE: Psychiatry, Pharmacy, Patient

ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.

BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.

RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.

Health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy (REMS) requirements and current label recommendations. Notable requirements of the REMS include:

  • For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program.
  • Zyprexa Relprevv injections must be administered at a REMS-certified health care facility with ready access to emergency response services.
  • Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours following an intramuscular injection.
  • Patients receiving Zyprexa Relprevv must be accompanied to their destination from the health care facility.

Read the MedWatch safety alert, including links to the Drug Safety Communication at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439472.htm

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Wegmans Announces Recall of (Frozen) Wegmans Organic Food You Feel Good About Just Picked Spinach, 12 Oz. Which May Be Contaminated With Listeria Monocytogenes

03/23/2015 01:08 PM EDT

 

Wegmans Food Markets, Inc. is recalling approximately 12,540 packages of Wegmans Organic Food You Feel Good About Just Picked Frozen Spinach, 12 oz. (UPC 77890-32932) due to possible contamination with Listeria monocytogenes. The product was sold in the frozen food department of the company’s 85 stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts between January 27 and March 21, 2015.

 

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Wegmans Announces Recall of (Frozen) Wegmans Organic Food You Feel Good About Just Picked Spinach, 12 Oz. Which May Be Contaminated With Listeria Monocytogenes

03/23/2015 01:08 PM EDT

 

Wegmans Food Markets, Inc. is recalling approximately 12,540 packages of Wegmans Organic Food You Feel Good About Just Picked Frozen Spinach, 12 oz. (UPC 77890-32932) due to possible contamination with Listeria monocytogenes. The product was sold in the frozen food department of the company’s 85 stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts between January 27 and March 21, 2015.

 

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Are Some Cosmetics Promising Too Much?

03/23/2015 1:45 PM EDT

 

Getting what you expected from your cosmetics?

 

Sometimes spending money in vain?

 

How to tell when some cosmetics claims promise more than they can deliver.

Read the Consumer Update to learn more.

 

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Join Facebook Forum on Youth Violence Prevention

When: March 28 – 27, 2015
Where: CDC’s VetoViolence Facebook Page

You’re invited to join this week’s “Ask the Expert” Facebook Forum on Youth Violence Prevention with CDC and Students Against Violence Everywhere during National Youth Violence Prevention Week.

Ask questions, share ideas, and discuss solutions on CDC’s VetoViolence Facebook page and get feedback from experts! 

If you have questions about risks, prevention strategies, and related issues, CDC and Students Against Violence Everywhere have answers. Participate by posting questions, comments, and resources

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Join Facebook Forum on Youth Violence Prevention

When: March 28 – 27, 2015
Where: CDC’s VetoViolence Facebook Page

You’re invited to join this week’s “Ask the Expert” Facebook Forum on Youth Violence Prevention with CDC and Students Against Violence Everywhere during National Youth Violence Prevention Week.

Ask questions, share ideas, and discuss solutions on CDC’s VetoViolence Facebook page and get feedback from experts! 

If you have questions about risks, prevention strategies, and related issues, CDC and Students Against Violence Everywhere have answers. Participate by posting questions, comments, and resources

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Giant Eagle Voluntarily Recalls Raisin Filled and Apricot Filled Cookies Due to an Undeclared Milk Allergen

03/20/2015 08:52 PM EDT

 

All lots of Giant Eagle brand Raisin Filled and Apricot Filled cookies, baked and sold individually from the Bakery department service counters inside Giant Eagle and Market District supermarkets through March 20, have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

 

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Texas Star Nut and Food Co. Inc. Natural Macadamia Nuts Are Being Voluntarily Recalled Due To Possible Salmonella Contamination

03/21/2015 08:41 AM EDT

 

Texas Star Nut and Food Co., Inc. of Boerne, Texas is voluntarily recalling Nature’s Eats Natural Macadamia Nuts, Lot Code #31435001, because it has the potential to be contaminated with Salmonella, 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

 

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Taylor Farms Florida Issues Allergen Alert on Undeclared Soy in Kale and Quinoa Salad

03/20/2015 05:50 PM EDT

 

Taylor Farms Florida Inc., of Orlando, FL is voluntarily recalling a limited quantity of Kale and Quinoa Salad because they have the potential of containing an undeclared soy allergen within the dressing packet in the salad. The recall was initiated after it was discovered that the ingredient label on the bottom of the packaging did not indicate the presence of soy.

 

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Aurora Products, Inc. Voluntarily Recalls Certain Aurora Natural Brand and Certain Private Label Brand Walnuts and Trail Mixes Due to Possible Health Risk

03/21/2015 03:59 PM EDT

 

Aurora Products, Inc. is conducting a voluntary nationwide recall of certain lots of NATURAL WALNUTS and TRAIL MIXES CONTAINING WALNUTS because they have the potential to contain Salmonella 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.

 

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La Terra Fina Recalls Organic Spinach Dip Sold in Bay Area Costco Clubs

03/21/2015 08:20 AM EDT

 

La Terra Fina is issuing a voluntary recall of its Organic Spinach Dip due to a potential health risk from Listeria exposure. The recall of product available in Bay Area Costco stores is a precaution.

 

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__________________

The Principle of Least Interest: He who cares least about a relationship, controls it.

Always misinterpret when you can.
ed11563


Guru

Status: Offline
Posts: 9186
Date:
Permalink  
 

Part 3 ...

 

 

Voluntary Recall for Potential Health Risk O’Coconut ™

03/22/2015 10:36 AM EDT

 

Nutiva, an Organic Superfoods company, has initiated a voluntary product recall of the following O’Coconut™ products after being notified by supplier that samples of a raw material in this product have the potential to be contaminated with Salmonella. “We are choosing to voluntarily recall three of our O’Coconut items as a precautionary measure to provide the safest products for our customers,” states John Roulac, Nutiva’s CEO.

 

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 That's all, I hope you found something worth knowing about.

 

Ed

 



__________________

The Principle of Least Interest: He who cares least about a relationship, controls it.

Always misinterpret when you can.
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