Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization. To date, there have been no reports of adverse events associated with this issue.

NEXTERONE is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which NEXTERONE is packaged.
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter – Anaphylaxis and Other Serious Hypersensitivity Reactions

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting—some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration.

Symptoms of anaphylaxis can include wheezing or difficulty breathing, swelling of the face or throat, hives or flushing, itching; abdominal cramping, abdominal pain or vomiting, back pain or chest pain, hypotension or shock.

BACKGROUND: Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,

  1. administration of Varubi (rolapitant) injectable emulsion should be stopped immediately.
  2. appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
  3. Varubi (rolapitant) injectable emulsion should be permanently discontinued.

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:

  1. Complete and submit the report Online: www.fda.gov/MedWatch/report
  2. 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

See the Health Care Provider Letter for important prescribing information to reflect the new safety information.

Hantavirus confirmed in recent traveler to northern Arizona

FLAGSTAFF – Coconino County Public Health Services District (CCPHSD) officials have announced a confirmed case of Hantavirus Pulmonary Syndrome (HPS) in a recent traveler to the County from outside Arizona. The individual traveled to multiple areas in northern Arizona and it is unknown where the current case contracted the virus.

The disease is transmitted to people who come into contact or breathe infected urine, droppings and/or saliva of wild mice (primarily deer mice). People who come into contact with rodents that carry hantavirus are at risk of contracting the disease. The illness has not been found to spread from person to person.

HPS is not limited to one geographic location. It can be present in many areas in the southwestern region of the United States where there is rodent activity, even if mice are never seen.

This is the first confirmed HPS case in Coconino County this year and the sixth case of HPS in Coconino County since 2007. Two cases resulted in death from complications caused by the illness. Symptoms of the illness could include fever, headache and muscle aches progressing rapidly to severe difficulty in breathing. Individuals experiencing these symptoms should see their physician immediately and mention their potential rodent exposure.

To prevent HPS, public health officials recommend the following clean-up methods for areas that may have rodent activity:

  1. Prior to starting cleanup, open all door and windows, especially in areas that have been closed for an extended period such as a garage, storage shed or second homes that are not used year-round. Leave open for 30 minutes before cleaning and if possible, allow direct sunlight on the area.
  2. Do not stir up dust in the infested area by vacuuming, sweeping, or any other means. This will allow virus particles to go into the air, where they can be breathed in, and potentially causing infection.
  3. When rodent droppings or nests are found in and around the home, spray them liberally with a household disinfectant (such as one-part bleach to nine parts water) and allow them to soak for at least 15 minutes. Any rodent droppings and rodent nests should be sprayed with a pesticide to kill fleas before disinfecting or disposing the carcasses.
  4. After disinfecting, wear rubber gloves and clean up the droppings with disposable materials such as paper towels, rags or disposable mop heads.
  5. Seal all materials, droppings or nests in double plastic bags and dispose of them in the trash.

Rodent-proof your home:

  1. Prevent rodents from entering the home by plugging or sealing all holes and gaps to the outside greater than 1/4-inch in diameter. Use steel wool, thick wire screen, metal flashing or cement to seal holes.
  2. Eliminate or reduce rodent shelter around the home by removing outdoor junk and clutter, and by moving woodpiles, lumber, hay bales etc., as far away from the house as possible.
  3. Do not make food easily available to rodents. Do not leave pet food in dishes and dispose of garbage in trash cans with tight-fitting lids.
  4. Prevent mice infestation inside your home with the use of traps and proper removal.

For more information regarding HPS, call the Coconino County Public Health Services District at 928-679-8750, toll-free at 877-679-7272 or visit www.cdc.gov/hantavirus/hps.

CCPHSD offers appointments for Seasonal Flu Shot

FLAGSTAFF – The Coconino County Public Health Services District (CCPHSD) is offering seasonal flu shots at the CCPHSD Clinic in Flagstaff. To schedule an appointment, call the Clinic at 928-679-7222 or toll-free at 1-877-679-7272.

The Centers for Disease Control and Prevention (CDC) recommends a yearly flu vaccination as the first and most important step in protecting against flu viruses. It is strongly recommended that everyone 6 months old and over get a flu shot each year.

The cost for a flu vaccination at a CCPHSD Clinic is $30 for adults and children. As a courtesy, the CCPHSD will bill an insurance company, but individuals seeking a flu shot should check with their insurance provider to determine whether they are covered. For people without insurance, the Vaccines For Adults/Children (VFA and VFC) programs are available to assist those that are unable to pay.

The following groups should get a flu vaccination because they are at high risk of having serious flu-related complications or because they live with or care for people at high risk for developing flu-related complications, including:

  • Pregnant women
  • Children younger than 5, but especially children younger than 2 years old
  • Children with special healthcare needs
  • People 50 years of age and older
  • People of any age with certain chronic medical conditions
  • People who live in nursing homes and other long-term care facilities
  • People who live with or care for those at high risk for complications from flu, including:
    Health care workers
    Household contacts of persons at high risk for complications from the flu
    Household contacts and out of home caregivers of children less than 6 months of age (these children are too young to be vaccinated)

Flu symptoms include fever, chills, muscle aches, cough, congestion, runny nose, headaches and fatigue. Complications of flu can include bacterial pneumonia, ear infections, sinus infections, dehydration and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes and can cause death.

In addition to getting a seasonal flu shot, good health habits will help you stay well. These simple actions can stop the spread of germs and help protect you and others from getting sick:

  • Wash your hands frequently during the flu season.
  • Avoid touching your eyes, nose or mouth.
  • Avoid contact with people who are sick.
  • Cover your mouth with your upper sleeve or with a tissue when coughing or sneezing.
  • Don’t share eating utensils, cups, and straws.
  • Stay home when you are sick.

Additional information is available at www.coconino.az.gov/health. Contact your health care provider or call the Coconino County Public Health Services District Clinic at 928-679-7222 or toll-free at 1-877-679-7272.

Page area birth certificate services expanded

PAGE – The Coconino County Public Health Services District (CCPHSD) has expanded birth certificate services at the Northern Region Office located at 467 Vista Ave., Page, AZ.

Beginning in July, birth certificate services will be available:

Second Tuesday of each month from 12 p.m. – 4:30 p.m.
Second Wednesday of each month from 8 a.m. – 1 p.m.

“Many people never think about whether they have an official copy of their birth certificate until they need it. Birth certificate may be required to obtain a driver’s license, a marriage license, to get a passport, to enroll in school,” said CCPHSD Chief Health Officer Marie Peoples. “Getting a birth certificate now may save valuable time when it’s needed.”

CCPHSD offers certified birth certificates only for births that occurred in Arizona. The cost is $20 each. To obtain a certified copy of a birth certificate from another state, contact that state’s vital records office.

CCPHSD can only correct or amend records for births that occurred after 1997. For births that occurred prior to 1997, correction paperwork must be sent to the State Office of Vital Records. The cost is $30 and includes a birth certificate.

Birth certificate services are also available by mail and at other locations throughout the County. For more information, call the Coconino County Public Health Services District at 928-679-7272 or toll-free at 1-877-679-7272 or visit www.coconino.az.gov/birthcertificates.

Back to School and Community Health Fair in Flagstaff

FLAGSTAFF – The Coconino County Public Health Services District is holding a Back to School and Community Health Fair on Saturday, from 9 a.m. to 12 p.m. on Saturday, July 29. The event will be held at the Health and Community Services Building, 2625 N. King St., Flagstaff, Az.

Students grades K – 12 will receive free backpacks and school supplies, while supplies last. Students must be present and complete an event passport to receive a backpack.

Students can receive vaccinations required for Arizona school entry and vaccinations recommended by Centers for Disease Control and Prevention (CDC). Insurance will be billed with no insurance copay or office visit fee regardless of insurance status. Please bring insurance card and immunization records.

Other services and activities available at the Health Fair include:

  1. Free sports physicals ~ Limited number available. Inquire at Check-in tent.
  2. Oral health information ~ Free toothbrushes (limited supply), meet Tootsie the Tooth.
  3. WIC, nutrition and injury prevention information.
  4. Review of children and adult immunization records.
  5. Fun activity stations.
  6. Prizes, giveaways, music.
  7. Learn more about the Health District and other community resources.

For more information visit www.coconino.az.gov/health.

Increase in pertussis (whooping cough) reported in Coconino County

FLAGSTAFF – The Coconino County Public Health Services District (CCPHSD) has confirmed an increase in pertussis (whooping cough) illness in Coconino County. CCPHSD is reminding individuals of the importance of vaccinations for both children and adults.

Early symptoms of pertussis are mild and cold-like, including runny nose, sneezing and coughing that becomes more persistent. Pertussis is easily spread when an infected person coughs. It can cause spells of violent coughing and gasping for breath in young children and can last weeks. Children often make a “whooping” noise when they breathe. This disease is most serious for babies under one year old, immunocompromised individuals and pregnant women.

Adults who get pertussis often have a cough, but don’t “whoop”. Unfortunately, many adults with pertussis are not treated and pass this disease on to others, possibly young children. Pertussis is easily spread from person to person. Transmission usually occurs by sharing close breathing space with an infected individual that is coughing or sneezing.

Any adults or children who have a cough that has lasted for over 14 days should be evaluated by their health care provider, especially if the illness includes coughing fits, vomiting after coughing, or whooping. Antibiotics are available to treat the infection and prevent further spreads of the disease.

Immunization is extremely important for the prevention and control of pertussis. The Centers for Disease Control and Prevention (CDC) recommend the DTaP (diphtheria, tetanus, and acellular pertussis) vaccine for infants and children through age 6. Tdap vaccinations, which contain protection against tetanus, diphtheria and pertussis, are recommended for preteens, teens and adults and should be given to 7 – 10 year olds who are not fully vaccinated against the illness. Pertussis vaccinations are required by the State of Arizona for school attendance. Please visit https://www.cdc.gov/pertussis/about/ for more information.

Pregnant women are encouraged to get Tdap with every pregnancy during weeks 27-36 regardless of previous vaccinations to provide optimal protection to the infant.

Adults who have close contact with infants (parents, grandparents, childcare providers and healthcare providers) should get a dose of Tdap. Getting vaccinated with Tdap – at least two weeks before coming into close contact with an infant – is especially important for families with, and caregivers of, new infants.

Vaccinations are available from healthcare providers or the Coconino County Public Health Services District Clinic, 2625 N. King Street, Flagstaff. Call the CCPHSD Clinic at 928.679.7222 for an appointment or for more information.

Pet services in Williams

clinic-15-05-22-3WILLIAMS — If you are coming to Williams for this long weekend (or pretty much any time), you probably wonder what pet services are available in town. Apart from the Chinese made toys and treats stocked in the general stores.

Veterinary services are available at the Williams Veterinary Clinic open from 8 a.m. to 5 p.m. Tuesday to Friday. The clinic is located at 122 3rd Street. They provide a full range of pet health care services. They also sell Science Diet dog food products at their store. On certain weekends, they hold a vaccine clinic at the Spoiled Rotten Pet Boutique. Their phone number is 928-635-5392.

200-Pets-02They do not, however, have emergency care. There are two locations in Flagstaff that provide emergency pet care. You might want to call ahead to make sure they know that you are coming.

  1. Canyon Pet Hospital, 1054 E. Old Canyon Court, Flagstaff, AZ 928-433-3970
  2. Westside Veterinary Clinic 963 W. Route 66, Flagstaff, AZ, 928-779-0148

Another emergency veterinary clinic is trying to get started in Flagstaff. According to the latest on their web site, the Veterinary Emergency & Specialty Center of Northern Arizona plans to open on May 29. They plan to be open all weekend long from Friday at 5 p.m. to Monday at 8:30 a.m. to provide emergency medical services for pets. The pet hospital will be open 24 hours on holidays when other veterinary clinics are closed.

200-dog-02As an aside to the Williams clinic, Traci started Spoiled Rotten Pet Boutique & Supplies (Facebook) located at 517 E. Historic Route 66 on the east end of town. They sell cat and dog toys and clothing, bedding and the like. They stock Science Diet foods and treats. They include a selection of treats from the Bubba Rose Biscuit Company that are baked treats iced with yogurt.
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On the grooming front, just down the street from Spoiled Rotten at 402 E. Route 66 is Manytails Pet Grooming. They have pet sitting and daycare services. They open Tuesday through Saturday at 9 a.m. You can call 928-635-8897 for appointments.
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If you are traveling from Kingman, Seligman—and all points west—to Williams, you might have a pet that just needs to be groomed. Or, perhaps, Manytails is too busy to get your pet groomed on time for that formal activity. You can call Aunty Abby’s Pet Services and Doggie Day Spa at 928-380-5123. Aunty Abby’s is located at 47125 N. 5th Street in Ash Fork. She provides bathing, grooming, nail clipping and pet sitting.

Stand Down a success despite the weather

Arizona Veterans Standdown Alliance photo.

Arizona Veterans Standdown Alliance photo.

FLAGSTAFF — The third High Country Stand Down at the Flagstaff National Guard Armory seems to have been a success. Despite the weather, District 4 Supervisor Mandy Metzger said that about 125 veterans came through the door just after opening. The event is organized by Philan Tree, assistant to Mandy.

The High Country Stand Down is a branch of the larger Arizona Veterans StandDown Alliance (Facebook). For the last three years the High Country Stand Down has been growing.

The event this year is dedicated to Flagstaff Marine Lance Davison, who suffered from PTSD and traumatic brain injury and took his own life in February 2014. Davison is one of the roughly 22 veterans who commit suicide in this country each day, or one every 65 minutes, according to a 2013 study by the U.S. Department of Veterans Affairs.

The Stand Down is a collection of services and gifts for homeless veterans and veterans in need. The tables and services all reflect the services available to veterans all year around.

Some of the services, such as the pet care provided at the event, are not just for veterans. Aspen Veterinary Clinic provided check-ups and medical services for pets. The Low Cost Spay/Neuter Clinic of Flagstaff gave free vaccines. Many of the local veterans seemed to be taking advantage of this service. One family brought in two dogs and about five cats to be vaccinated.

Another service that anyone who resided in Coconino County should be aware of, and take advantage of, is the Downwinder’s Program. The North Count Healthcare system presented their radiation exposure screening and education (RESEP) program. If you lived in Coconino County—and other certain areas of Nevada, Utah or Arizona—from 1959 to 1962, you may be eligible for compensation due to the nuclear weapons testing in Nevada. The Northern Arizona Health Care system provides free screening for people who lived in those regions during that period for cancer and other anomalies that might have been a result of those tests. They even help you file the paperwork.

Northern Arizona University provided dental technicians for dental screening and to assist veterans in filing paperwork for dental work needed.
StandDown-15-05-15-04
The Salvation Army provided hamburgers, hotdogs and chips for the event. They also gave out sack lunches.

One important feature of the event for the last two-years was the Veterans Court. The Veterans Court is called a therapeutic court in the legal system and is available to veterans all year round. This special court was set up at the event solely to quash pending warrants and allow veterans to get their cases moving in the Veterans Court system. This is not the way the normal court works.

Judge Cathleen Nichols, of Coconino Superior Court Division 5, is the coordinator for the Veterans Court. There are two other therapeutic courts for DUIs and mental health issues which work in similar fashion.

Judge Nichols explained that in the normal course of an arrest, the fact that a defendant is a veteran may enter into the paperwork. If it does not, the veteran may identify himself. Self-identification does require the veteran to prove service, such as a DD-214 or retired identification card. This is particularly useful in misdemeanor cases where a defendant is usually not represented by a lawyer.

Once a veteran is identified, the case is reviewed by the office of the County Attorney to see if they can allow it to be referred to the Veterans Court. The attorney of the defendant is also consulted if he has one. It is up to the defendant to decide if they choose to take this course. It does not allow the veteran to “get away” with anything. The veteran will have to agree to probation with all that entails. They may also be required to attend certain classes or programs and report their progress to the court.

Judge Nichols pointed out two unusual features of this therapeutic court in the Coconino County Superior Court system. First is that the veteran does not necessarily have to have an honorable discharge. A person with a convenience of the government or other type discharge may be considered for the Veterans Court. The second feature is that this is the only court system in the State that currently considers felony cases.

The High Country Stand Down also provided back packs stocked with sleeping bags and hygiene kits. They also provided new shoes and the Goodwill Industries provided free clothing for the homeless veterans.

Any organization or corporation which may be able to provide services or products to veterans may participate in the program. To be involved in the Fourth Annual High Country Stand Down, contact Philan Tree at the office of Mandy Metzger at 928-679-7154. For other areas you can consult the Arizona Stand Down Alliance web site.

High Country Stand Down for Veterans next Friday

stand-down-logoFLAGSTAFF — The 3rd Annual High Country Stand Down for Veterans will be held Friday, May 15, from 10 a.m. to 3 p.m. The event provides services to homeless and at-risk veterans and their families.

Along with a hot meal, the volunteers of the event will provide hygiene kits, Haircuts, clothing and survival gear. For pets they will provide pet food and pet care. Legal assistance, notary services will also be available along with dental, vision and medical care.

The High Country Stand Down will be held at the Flagstaff Armory, 320 N. Thorpe Road in Flagstaff next to Thorpe Park.