https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

Summary

Company Announcement

Three Recalls Designated as Class I by FDA; One Designated as Class II

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System.

Three of the recalls, which BD announced on Aug. 4, 2020External Link Disclaimer,External Link Disclaimer have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Click here to read more on this story.

Adapted from a press release by Takeda Pharmaceuticals USA.

 
This May, the U.S. Food and Drug Administration (FDA) approved extending the indication of Gattex® (teduglutide) for injection to pediatric patients 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous feeding (parenteral support).

In a 24-week pediatric study, Gattex helped reduce the volume of daily parenteral support (PS) required and time spent administering PS. Some children even achieved complete freedom from PS. Fifty-nine pediatric patients with SBS aged 1 year through 17 years chose whether to receive Gattex or standard of care (SOC). Patients who chose to receive Gattex treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm. The recommended dosage of Gattex is 0.05 mg/kg/day. Randomization to the Gattex dose groups was stratified by age.

At the end of the 24-week study, 69% of patients (18/26) who took Gattex 0.05 mg/kg each day reduced PS volume by 20% or more. Based on patient-diary data, patients who received Gattex 0.05 mg/kg/day experienced a 42% mean reduction in PS volume (mL/kg/day) from baseline (-23 mL/kg/day from baseline). At week 24, 38% of patients (10/26) were able to reduce PS infusion by at least 1 day per week. Patients reduced their PS infusion time by 3 hours per day on average compared to baseline. In addition, during this study 3 out of 26 (12%) children who received Gattex 0.05 mg/kg/day completely weaned off PS.

Gattex has a demonstrated safety profile that is similar overall in pediatric and adult patients. The most common adverse reactions (≥10%) seen in adult patients treated with Gattex in clinical trials were abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity. For more information go to www.gattex.com.

Gattex has been shown to reduce parenteral support volume and to help some children with SBS wean off of intravenous nutrition over time during clinical studies.

www.fredhutch.org, 4/10/19

Dr. Robert O. Hickman, a pediatric nephrologist and inventor of a catheter that revolutionized care for cancer patients, died on April 4. He was 92.

In the 1970s, Hickman was a founding member of the transplant team at Fred Hutchinson Cancer Research Center that pioneered the Nobel-Prize winning treatment. His contribution to that effort: The lifesaving device that bears his name and is still used worldwide to deliver IV nutrition, draw blood and deliver chemotherapy.

The Hickman catheter “was a gift to the world,” said Dr. Fred Appelbaum, executive vice president and deputy director of Fred Hutch, who worked with Hickman.

“People make contributions in lots of ways,” he said. “Some have deep scientific insights that uncover DNA or how viruses work. Bob’s contribution, from a scientific standpoint, was relatively simple. But his invention saved more suffering, anxiety and pain than almost anyone I can imagine.”

Click here to read more on Dr. Hickman.

            New treatment/therapy options are available that may be helpful for some Oley members. If you think these might be helpful for you, mention them to your physician.

Motility Treatment Approved (Motegrity™)

            The U.S. Food and Drug Administration (FDA) has approved Motegrity (prucalopride), a once-daily, oral treatment option for adults with chronic idiopathic constipation (CIC).According to the manufacturer, Shire PLC, “Motegrity, a selective serotonin-4 (5-HT₄) receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility.” Shire expects to launch Motegrity in the U.S. in 2019. The company explains, “While not all patients may be right for treatment, Motegrity represents an important new option.”

Click here to read Shire’s press release.

Pediatric Parenteral Nutrition Lipid Available (Omegaven®)

            Fresenius Kabi has announced that Omegaven (fish oil triglycerides) injectable emulsion is now commercially available in the United States. Omegaven was approved by the FDA in July 2018. Previously the lipid had been available in the U.S. for compassionate use only. Omegaven is an intravenous lipid emulsion that provides calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis, or PNAC. The company says, “Omegaven is the first and only FDA-approved fish oil lipid emulsion for this condition.”

Dr. Carol Smith at the University of Kansas, who cooperating with Oley consumers, has made many important research contributions to the HPN field, has NIH funds to study factors influencing HPN outcome in teenagers. We all know the HPN handoff from parents to a teenager is complicated. Dr. Smith’s current project attempts to identify critical components for a smooth transition.

Research often has tedious aspects but eventually it’s the key to improving HPN outcome and ensuring HPN funding, so please, please get involved.

Lyn Howard, MD
Oley grandmother and with the Oldenburg family “Oley”, co-founder of the Foundation”

To take part in this research study or for more information, please call or email Cathy Harrington, phone (518)262-5079, email harrinc@mail.amc.edu OR complete the contact form HERE.

Click here for the Fresenius Kabi press release

By: Kelsey Stein

AL.com, January 29, 2016

The former head pharmacist and the president of an Alabama compounding pharmacy have agreed to plead guilty for distributing contaminated drugs linked to nine deaths in Birmingham-area hospitals.

Advanced Specialty Pharmacy, which conducted business as Meds IV, is no longer in operation.

Click here to read the full story at AL.com, 1/26/2016

Click here to read full report (10/6/15)

     New York State Governor Andrew Cuomo has signed into law a bill (S7893, A10140) that requires all commercial major medical insurances to cover the provision of ostomy supplies. The bill takes effect on January 1, 2015.             

     The United Ostomy Associations of America (UOAA) notes that New York and Connecticut are the only states to have such legislation in place. They also note that New York’s Child Health Plus plan does not cover ostomy supplies. Hoping to change that, the UOAA is looking for examples of problems or hardship resulting from non-coverage by this program. If anyone has a child with an ostomy who is covered by Child Health Plus, please contact the UOAA at (800) 826-0826 or visit www.ostomy.org.

LifelineLetter, January/February 2015

529 ABLE Beneficiaries Will Still Qualify for Supplemental Security Income

By ANNE TERGESEN

January 11, 2015

A new type of savings vehicle for the first time offers the disabled and their families the benefits of tax-free growth.

Click here to read the full article in The Wall Street Journal 1/11/15

Susan Agrawal               

Complex Child E-Magazine, a parent-written online magazine for families dealing with medical complexity, has created a new resource to help families obtain Medicaid waiver coverage for their children. A new Web site, www.KidsWaivers.org, will provide information on Medicaid waivers, including a comprehensive list of waiver programs available for children in each state.

Waivers               

Children who live at home but whose disability or medical condition would require them to otherwise live in an institution (including a hospital, nursing facility, or intermediate care facility) are eligible for Medicaid waivers. Most children on home parenteral nutrition (HPN), and some on home enteral nutrition (HEN), will qualify.               

Children who receive HPN or HEN often have huge medical expenses and unmet needs. Even if they have insurance, their policies may not cover critical needs, such as HEN formula or private duty nursing. Medicaid waivers help provide children with more comprehensive coverage, including full primary or secondary Medicaid coverage, and in some cases, additional "Waiver Services” that vary by program. Most of these programs waive family income limits, allowing children of all incomes to access Medicaid.               

 

Each state is allowed to create its own programs for children, typically following four different pathways, including 1915(c) Home and Community Based Waivers; TEFRA/Katie Beckett Waivers; 1115 Demonstration Waivers; and state-based programs. The eligibility requirements and benefits of each program vary considerably from state to state. Because each program is unique, it can be challenging to find information on many of them. We hope to simplify the process by compiling as much information about each program as possible onto one site.

KidsWaivers.org     

We’ve completed Phase I of three intended phases for the site: creating a comprehensive list of programs in each state, including their target population, level of care, and number of spots. We’ve obtained this information from state and federal government Web sites. Phase II will involve creating individual pages for each state, with families and advocates providing inside information on each program. Phase III will include an advocacy component, connecting families to help preserve these critical programs.               

 

To learn more, visit www.KidsWaivers.org. If you have corrections or additional information to add to the resource, please use the contact form on the Web site or e-mail info@kidswaivers.org.              

 

 "Medicaid Waiver programs help provide services to people who would otherwise be in a...nursing home or hospital to receive long-term care in the community.”— www.en.wikipedia.org 

 

LifelineLetter, May/June 2014

Click here to read 'Hannah's Law' signed by Cuomo article (10/22/13)

Click here to read Bill S5034-2011 - Enacts "Hannah's law"; requires certain insurance policies to include coverage for the cost of enteral formulas for the treatment of eosinophilic disorders.