FDA warns of potential contamination in multiple brands of drugs, dietary supplements
PRESS RELEASE ISSUED 8/ 11/ 17
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.
The drug and dietary supplement products made by PharmaTech include liquid docusate sodium drugs (stool softeners), as well as various dietary supplements including liquid vitamin D drops and liquid multivitamins marketed for infants and children.
“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems,” said FDA Commissioner Scott Gottlieb, M.D. “These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online – making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.”
According to the Centers for Disease Control and Prevention (CDC), B. cepacia poses the greatest threat to hospitalized patients, critically ill patients and people with health problems such as weakened immune systems and chronic lung diseases. The symptoms of B. cepacia infections vary widely from none at all to serious respiratory infections. It can spread from person-to-person by direct contact and is often resistant to common antibiotics.
Consumers, pharmacies and health care facilities should immediately stop using and dispensing all liquid drug and dietary supplement products manufactured by PharmaTech and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands. These distributors voluntarily recalled the following products:
LEADER BRAND
Liquid Multivitamin Supplement for Infants and Toddlers 50 mL, UPC: 096295128611 ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL, UPC: 096295128628 ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid 236ML 00904-5023-09 ALL LOTS
Poly-Vita Drops 50ML 00904-5099-50 ALL LOTS
Poly-Vita Drops W/Iron 50ML 00904-5100-50 ALL LOTS
Ferrous Drops Iron Supplement 50ML 00904-6060-50 ALL LOTS
D-Vita Drops 50ML 00904-6273-50 ALL LOTS
Tri-Vita Drops 50ML 00904-6274-50 ALL LOTS
Senna Syrup 237ML 00904-6289-09 ALL LOTS
RUGBY LABORATORIES
C Liquid 500mg 118ML 00536-0160-97 ALL LOTS
Diocto Liquid 50mg/5ml 473ML 00536-0590-85 ALL LOTS
Ferrous Sulfate Elixir 473ML 00536-0650-85 ALL LOTS
Fer Iron Liquid 50ML 50ML 00536-0710-80 ALL LOTS
Senexon Liquid 237ML 00536-1000-59 ALL LOTS
Diocto Syrup 60MG/15ML 473ML 00536-1001-85 ALL LOTS
Aller Chlor Syrup 120ML 00536-1025-47 ALL LOTS
Calcionate Syrup 16OZ 00536-2770-85 ALL LOTS
Cerovite Liquid 236ML 00536-2790-59 ALL LOTS
D3 400iu Liquid 50ML 00536-8400-80 ALL LOTS
Poly-Vitamin Liquid 50ML 00536-8450-80 ALL LOTS
Tri-Vitamin Liquid 50ML 00536-8501-80 ALL LOTS
Poly-Vitamin W/Iron Liquid 50ML 00536-8530-80 ALL LOTS
On Aug. 8, 2017, the FDA advised health care professionals and patients not to use any liquid drug products manufactured by PharmaTech, following CDC’s laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia linked to recent patient infections.
In 2016, the FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech’s Davie, Florida, facility after the products were implicated in CDC’s public health investigation into a multistate outbreak of B. cepacia infections.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drugs and dietary supplements products to the FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA to expand public education campaign to focus on prevention of youth e-cigarette use
PRESS RELEASE ISSUED 8/ 8/ 17
Today, the U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.
“While we pursue a policy that focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes, and to help move those who cannot quit nicotine altogether onto less harmful products, we will also continue to work vigorously to keep all tobacco products out of the hands of kids,” said FDA Commissioner Scott Gottlieb, M.D. “Educating youth about the dangers of tobacco products has been a cornerstone of our efforts to reduce the harms caused by these products. Including e-cigarettes and other ENDS products in our prevention work not only makes sense, it reflects the troubling reality that they are the most commonly-used tobacco product among youth.”
More than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016. Data also show about half of all middle and high school students who were current tobacco users also used two or more tobacco products last year. This use by children and teens is especially concerning because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future.
The FDA’s recently announced plan puts nicotine and the issue of addiction at the center of the agency’s efforts. This policy aims to strike a careful balance between the regulation of all tobacco products, and the opportunity to encourage development of innovative tobacco products that may be less dangerous than combustible cigarettes. But, importantly, the approach also continues to focus on the need to reduce the access and appeal of all tobacco products to youth, including e-cigarettes and other ENDS, and maintains all of the existing regulations that currently apply to these products.
To re-double efforts to address the concerning youth use of these products, the FDA will capitalize on its already well-known “The Real Cost” campaign this fall by releasing new digital materials that are targeted to youth and focused on ENDS. This will include online videos to educate kids about the dangers of using e-cigarettes or other ENDS. Among the messages that will be part of the campaign is the potential for nicotine to rewire a teen’s brain and create cravings that can lead to addiction. At the same time, the agency also is undertaking an effort to shape a new, full-scale campaign that is exclusively focused on youth use of ENDS. The FDA plans to launch this new, more extensive content in 2018.
Since its launch in February 2014, the FDA’s “The Real Cost” campaign has proven to be successful, with a recent evaluation concluding that the campaign prevented nearly 350,000 youth aged 11 to 18 nationwide from initiating smoking from 2014 to 2016. With nearly 2,500 youth under the age of 18 in the United States trying their first cigarette each day, youth tobacco prevention campaigns remain essential to protecting public health.
The campaign is just one component of the agency’s efforts to restrict youth access, limit youth appeal and reduce toxic exposure to youth from all tobacco products. The FDA continues to enforce important existing regulations specifically aimed at addressing youth access to ENDS and other newly-regulated products, including banning the sale of tobacco products to youth under age 18, requiring age verification by photo ID, and prohibiting free samples. Since August 2016, the FDA has issued over 6,400 warning letters to brick and mortar and online retailers for selling newly-regulated tobacco products such as e-cigarettes to minors.
As previously announced, the FDA also is exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth. In particular, the agency is pursuing product standards for ENDS that would address known risks. This could include measures on battery safety, flavors/designs that appeal to youth, child-resistant packaging, and product labeling to prevent accidental child exposure to liquid nicotine. The FDA also intends to seek public comment on the role that flavors in tobacco products play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS, including restrictions on how products may be sold and advertised, to further reduce youth exposure and access to these products.
“The FDA has a multi-pronged effort to protect kids from using any nicotine-containing product, including e-cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “As we continue to learn more about these products and their relationship to youth, the agency will be better prepared to help address the issue of youth use through science-based educational efforts and regulatory policies that will ultimately pay the greatest dividends in reducing tobacco-related disease and death.”
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
CDC: More Americans have epilepsy than ever before
PRESS RELEASE ISSUED 8/ 10/ 17
The number of U.S. adults and children with epilepsy is increasing, with at least 3.4 million people living with the disorder, according to data released today in CDC’s Morbidity and Mortality Weekly Report. It’s the first time epilepsy estimates have been available for every state.
The data show the disorder is widespread. In 2015, about 3 million U.S. adults and 470,000 children had active epilepsy (under treatment or with recent seizures). The number of adults with active epilepsy rose from 2.3 million in 2010 to 3 million in 2015. The number of children with the condition increased from 450,000 in 2007 to 470,000 in 2015. These increases are likely due to population growth.
“Millions of Americans are impacted by epilepsy, and unfortunately, this study shows cases are on the rise,” said CDC Director Brenda Fitzgerald, M.D. “Proper diagnosis is key to finding an effective treatment – and at CDC we are committed to researching, testing, and sharing strategies that will improve the lives of people with epilepsy.”
Epilepsy is a disorder of the brain that causes seizures. Different conditions can cause epilepsy, such as stroke, brain tumor, head injury, central nervous system infections, or genetic risks. Although epilepsy is widely recognized by the public, few people understand it, even among those who know someone with the disorder.
Key findings from analysis of epilepsy rates
The CDC study provides national and state-specific estimates of epilepsy prevalence based on the 2015 National Health Interview Survey, and the National Survey of Children’s Health, and the 2014 Current Population Survey.
Overall, 1.2 percent of the U.S. population (3.4 million people) reported active epilepsy in 2015.
The number of cases of active epilepsy among adults ranged from 5,100 in Wyoming to 367,900 in California.
The number of epilepsy cases among children ranged from 800 in Wyoming to 59,800 in California.
Eleven states had more than an estimated 92,000 people with epilepsy.
Data from 2010-2015 indicate increases in the number of persons with active epilepsy, probably because of population growth.
CDC researchers and others have previously reported that many adults with epilepsy face challenges including work limitations, difficulty finding transportation, and difficulty affording medical care. Students with epilepsy are more likely to fall behind in school and to need special education services. Children with epilepsy are more likely to live in low-income households.
“Epilepsy is common, complex to live with, and costly. It can lead to early death if not appropriately treated,” said Rosemarie Kobau, M.P.H, head of CDC’s Epilepsy Program. “Everyone should know how to recognize a seizure and how to give appropriate first aid.”
Recognizing seizures
There are at least 30 different types of seizures. Sometimes it is hard to tell that a person is having a seizure. People having some types of seizures may seem confused or look like they are staring at something that isn’t there. Other seizures can cause people to fall, shake, and become unaware of what’s going on around them.
First aid for seizures involves keeping the person safe until the seizure stops on its own and knowing when to call 911 for emergency assistance.
People should share concerns about their seizure symptoms with their doctors. A person with epilepsy who has uncontrolled seizures may want to see a neurologist specifically trained to treat epilepsy. Health care providers should learn more about how to classify seizures and treat epilepsy appropriately.
CDC’s Partnership efforts to address epilepsy
CDC’s Epilepsy Program collects data to monitor epilepsy trends, mortality, costs, and impact on families. CDC also collaborates with partners such as the Epilepsy Foundation, the American Epilepsy Society, and other researchers to:
Keep children and adults with epilepsy safe in their communities by conducting seizure recognition and first aid training programs for school nurses, school staff, law enforcement, first responders, child care providers, and older adult caregivers.
Reach rural and underserved populations with proven epilepsy self-management programs that can reduce health care costs and improve quality of life.
CDC: First Fungal Disease Awareness Week Encourages Patients, Doctors To “Think Fungus”
PRESS RELEASE ISSUED 8/ 9/ 17
What
CDC organized the first Fungal Disease Awareness Week to highlight the importance of recognizing serious fungal diseases early enough to provide life-saving treatment. Fungal diseases are often caused by breathing in very small fungi from the environment or by touching fungi on surfaces. Considering fungal diseases when diagnosing an infection is one of the most important ways to reduce delays in diagnosis and treatment of potentially life-threatening infections, which can save lives.
The week is an opportunity for partners to get people with infections to “Think Fungus” if their symptoms are not getting better with treatment and to talk to their doctor about the possibility of a fungal infection. Doctors are encouraged to “Think Fungus” if patients have symptoms that are not improving with treatment, particularly patients with weakened immune systems.
When
August 14–18, 2017. Join us in spreading the word by signing up for the #FungalWeek Thunderclap on Monday, August 14, at 10 a.m. ET: http://thndr.me/r38Aq4
Why
Fungal diseases can cause serious illnesses and death, yet often go undiagnosed because their symptoms look like those of other diseases. For instance, Valley fever is an inhaled fungal disease that is often misdiagnosed as bacterial pneumonia, resulting in the wrong treatment and putting patients at risk of antibiotic-resistant infections.
Concerning facts about fungal disease:
About 46,000 cases of healthcare-associated invasive Candida infection occur each year in the United States.
Candidemia – a type of invasive Candida infection – is one of the most common causes of healthcare-associated bloodstream infections in the United States. Nearly 1 in 3 people with this infection die.
Some types of Candida and Aspergillus infections are becoming harder to treat with the most commonly used antifungal medicines due to increasing antimicrobial resistance.
About 150,000 Valley fever infections occur in the United States each year, yet only about 10,000 cases are diagnosed and
The fungus that causes Valley fever mainly lives in Arizona, California, Nevada, New Mexico, Texas, and Utah. California reported 5,372 cases in 2016, the highest annual number ever reported in that state.
Globally, fungal diseases like Cryptococcus infection are a big problem for people with weakened immune systems, particularly those with HIV/AIDS. Often, the people live in lower-income areas where diagnosis and treatment can be challenging.
Worldwide, an estimated 220,000 new cases of cryptococcal meningitis occur each year, resulting in about 180,000 deaths.
People most commonly affected by serious fungal diseases include those with cancer, HIV/AIDS, organ or stem cell transplants, people in hospitals, and people taking medicines that weaken the immune system. People with weakened immune systems are more likely to get serious fungal infections in the lungs, blood, and brain.
Where:
Information and resources about Fungal Disease Awareness Week can be found at https://www.cdc.gov/fungal/awareness-week.html.
CONGRESSIONAL WATCH
Sen. Cantwell Announces Grant to Bolster Economic Development in Tri-Cities
PRESS RELEASE ISSUED 8/ 11/ 17
WASHINGTON, D.C. – Today, U.S. Senator Maria Cantwell (D-WA) announced that the Benton-Franklin Council of Governments had been awarded an Economic Development Administration (EDA) grant to implement a comprehensive economic development strategy (CEDS) for the Tri-Cities region.
The grant contributes $75,000 to the $150,000 CEDS project, which establishes a roadmap for private and public sector collaboration to create economic development that strengthens and diversifies the regional economy, supports private investments, and creates jobs in the region.
“This grant is critical to helping provide the vision Tri-Cities needs to continue to create sustainable jobs and spur diverse economic development,” said Cantwell, a member of the Senate Small Business Committee. “Creating strong private and public partnerships will help the Tri-Cities find new and innovative ways to increase job growth and economic opportunity.”
Senator Cantwell has been an ardent supporter of EDA grants during her career in the Senate. She consistently supports the program during the appropriations process, ensuring that strong economic development projects throughout the country receive the necessary funding.
FROM OLYMPIA HEALTH WATCH
DOH: State revokes, suspends licenses, certifications, registrations of health care providers
PRESS RELEASE ISSUED 8/ 9/ 17
OLYMPIA -- The Washington State Department of Health has revoked or suspended the licenses, certifications, or registrations of health care providers in our state. The department has also immediately suspended the credentials of people who have been prohibited from practicing in other states.
The department’s Health Systems Quality Assurance Division works with boards, commissions and advisory committees to set licensing standards for more than 80 health care professions (e.g., medical doctors, nurses, counselors).
Information about health care providers is on the agency’s website. Click on “Look up a health care provider license” in the “How Do I?” section of the Department of Health home page (doh.wa.gov). The site includes information about a health care provider’s license status, the expiration and renewal date of their credential, disciplinary actions and copies of legal documents issued after July 1998. This information is also available by calling 360-236-4700. Consumers who think a health care provider acted unprofessionally are also encouraged to call and report their complaint.
Franklin County
In July 2017 the Nursing Assistant Program charged registered nursing assistant Shelby Rose Waddell (NA60733211) with unprofessional conduct and immediately suspended her credential. In 2017 Waddell’s Oregon registered nursing assistant credential was revoked for financial exploitation.
Island County
In July 2017 the Dental Commission entered an agreement with dental assistant Lindsey Anita McCollum (D160384167) that indefinitely suspends her credential. McCollum worked at a community health center where she diverted controlled substances for her own use. McCollum used the Drug Enforcement Administration number of a former dentist at the center to issue at least 20 controlled substance prescriptions to herself and two patients, and fraudulently filled the prescriptions without informing the dentist or the patients.
King County
In July 2017 the secretary of health indefinitely suspended the registered nursing assistant credential of Bradley Curtis Holt (NA60210341), who fell asleep while caring for a vulnerable adult and didn’t follow a physician’s orders to administer the vulnerable adult’s medications in a timely manner. The state Department of Social and Health Services found that Holt neglected a vulnerable adult, and will not allow him to be employed in caring for or having unsupervised access to vulnerable adults.
Kitsap County
In July 2017 the Nursing Commission indefinitely suspended the licensed practical nurse credential of Irene Enriquez Cessor (LP00043227), who didn’t abide by probationary requirements for performance evaluations and continuing education.
Pierce County
In July 2017 the Home Care Aide and Nursing Assistant programs charged home care aide and certified nursing assistant Orlando Earl Sawyer (HM60630009, NC60754645) with unprofessional conduct and immediately suspended his credentials. Sawyer’s California nurse assistant and home health aide licenses were revoked in connection with locking his grandmother in an apartment.
On POVERTY
HUD REPORTS "WORST CASE HOUSING NEEDS" INCREASED IN 2015
8.3 million households paid more than half their income for rent or lived in substandard housing
PRESS RELEASE ISSUED 8/ 9/ 17 (source link)
WASHINGTON – The number of very poor unsubsidized families struggling to pay their monthly rent and who may also be living in substandard housing increased between 2013 and 2015, according to a new report released today by the U.S. Department of Housing and Urban Development. HUD reports that in 2015, 8.3 million very low-income unassisted families paid more than half their monthly income for rent, lived in severely substandard housing, or both. Read HUD’s latest estimate of Worst Case Housing Needs.
“Two years ago, our nation was still feeling the aftershocks of our housing recession with rents growing faster than many families’ incomes,” said HUD Secretary Ben Carson. “After years of trying to keep up with rising rents, it’s time we take a more holistic look at how government at every level, working with the private market and others, can ease the pressure being felt by too many un-assisted renters. Today’s affordable rental housing crisis requires that we take a more business-like approach on how the public sector can reduce the regulatory barriers so the private markets can produce more housing for more families.”
Demand for affordable housing is growing faster than the construction of homes working families can afford to rent, especially in high-cost areas of the country. The Trump Administration is seeking to stimulate the production and preservation of affordable housing in a number of ways. By pursuing housing finance reform, the Administration seeks to unwind the Federal government’s role in the private mortgage market and ease the stress on rental markets.
Worst Case Housing Needs are defined as renters with very low incomes (below half the median in their area) who do not receive government housing assistance and who either paid more than half their monthly incomes for rent, lived in severely substandard conditions, or both. HUD's report finds that housing needs cut across all regions of the country and include all racial and ethnic groups, regardless of whether they live in cities, suburbs or rural areas. In addition, HUD concluded that large numbers of worst case needs were also found across various household types including families with children, senior citizens, and persons with disabilities.
HUD’s estimate is part of a long-term series of reports measuring the scale of critical housing problems facing very low-income un-assisted renters. Based on data from the 2015 American Housing Survey conducted by the U.S. Census Bureau, the number of these “Worst Case Housing Needs” increased from 2013 yet remain lower than the nearly 8.5 million households reported in 2011.
WORLD AND NATIONAL NEWS BRIEFS & COMMENTARY
UN NEWS CENTER: Youth can play 'critical role' in creating a peaceful world for generations to come – UN chief
11 August 2017 – In the lead-up to International Youth Day, marked annually on 12 August, the United Nations kicked off a commemorative event at its New York Headquarters with a message from Secretary-General António Guterres, who underscored his commitment to young people.
UN NEWS CENTER: UN rights office 'deeply concerned' about deteriorating humanitarian conditions in Gaza
11 August 2017 – The United Nations human rights office today expressed deep concern about the steadily deteriorating humanitarian and human rights conditions in Gaza, especially the restrictions on the enclave's power supply.
NATIONAL
WSJ: Rural America's Childbirth Crisis: The Fight to Save Whitney Brown
MCMINNVILLE, Tenn.—Whitney Brown was in labor with her first baby when suddenly she couldn’t breathe.
Convulsions shook her body. Ms. Brown’s blood pressure and oxygen levels dropped, and the baby’s heart rate plunged. Nurses at Saint Thomas River Park Hospital called obstetrician Dawnmarie Riley, who minutes later burst into the operating room in such a rush her hospital scrubs were inside out.
NYT: ‘We’ve Had Enough’: Conservatives Relish the ‘Fury’ in Trump’s Talk
AUGUSTA, Ga. — “Fire and fury”? Eugene Yu could not have said it better himself.
Mr. Yu, 62, who emigrated here from South Korea, is an American citizen, a United States Army veteran and a staunch supporter of President Trump. Like many conservatives in and around this midsize Southern city – home to the Masters golf tournament and an important National Security Agency cryptology center — he was not scared, but rather thrilled this week when President Trump used those exact words to threaten the North Korean government.
PJ MEDIA: Korea and the Democrats' Deep Psychological Fear that Trump Is Right
COMMENTARY
One of the unspoken 'indications' in the medical sense of the ever-metastasizing Trump Derangement Syndrome is that the sufferers have a deep conscious/unconscious fear that Trump is right. What if the man they have excoriated unremittingly as a barbarian-racist-xenophobe-homophobe -misogynist-nitwit turns out to have been on the correct side of a fair number of issues on which they have failed, sometimes miserably, for decades? Talk about personality disintegration — it would be hari-kari meets the Wicked Witch of the West. Well, emotionally anyway.
This week's Bible Study
GOSPEL WAY: Planned Parenthood?
Public school sex education is mainly pushed by groups like the Planned Parenthood Federation of America (PPFA). The name sounds innocent, but how innocent are its programs?
Nearly all PPFA clinics give abortion referrals, and from 2011-2014 Planned Parenthood actually performed over 1.3 million abortions (www.frc.org/plannedparenthoodfacts). Former PPFA head Alan Guttmacher said, "...the only avenue (we can) travel to win the battle for abortion on demand is through sex education" (via "Sex Education and Mental Health Report"). Do you want schools to educate your children to practice "abortion on demand"?
https://www.gospelway.com/topics/family/planned_parenthood.php
