VEText 1 Year Later—Still Growing

Article Type
Changed
Wed, 03/27/2019 - 11:39
One year later, VEText shows an improvement in No Show rates and eases the appointment process for veterans at the VA.

Nearly 6 million veterans get health care scheduling reminders via VEText, an interactive mobile program launched a year ago. More than 70 million text messages later, how is VEText doing? Apparently, well. The VA says an “overwhelming majority” of veterans like the enhanced access. Only 4% have opted out.

The VA has worked to improve the user experience along the way. The latest enhancement allows the VA to send facility and clinic location in the unsecured text message appointment reminders. One user, James Preston, interviewed for a VA article, says at the Loma Linda VA Medical Center veterans still had to use the information desk to find out exactly where they needed to go. “Now it’s almost perfect,” he says, “because it provides all the necessary information.” Deanna Callahan, innovation specialist and National Program Manager for VEText, says before VEText, the VA was relying on phone calls, robocalls, and mail. “We wanted to modernize our efforts to not only bring text message appointment reminders but go above and beyond and positively affect the No Show rate.” It worked—the No Show rate has dropped from 13.7% to 11.7% in the year the program has been active.

The system automatically enrolls veterans based on phone information already on file, but they can opt out by replying STOP to a reminder. Accidentally opting out is easily reversed by replying START to a previous reminder. Reminders are sent for clinical appointments at local medical centers and outpatient clinics, but not for Lab, Community Care, Research, Telephone Clinics, or Home-based Primary Care. (The reminders are additional—they do not replace letters, postcards, or automated phone call reminders.) VEText itself does not cost the veteran anything, but text messaging rates may apply, depending on individual cell phone plans. For more information, go to www.va.gov/HEALTH/vetext_faqs.asp.

Publications
Topics
Sections
One year later, VEText shows an improvement in No Show rates and eases the appointment process for veterans at the VA.
One year later, VEText shows an improvement in No Show rates and eases the appointment process for veterans at the VA.

Nearly 6 million veterans get health care scheduling reminders via VEText, an interactive mobile program launched a year ago. More than 70 million text messages later, how is VEText doing? Apparently, well. The VA says an “overwhelming majority” of veterans like the enhanced access. Only 4% have opted out.

The VA has worked to improve the user experience along the way. The latest enhancement allows the VA to send facility and clinic location in the unsecured text message appointment reminders. One user, James Preston, interviewed for a VA article, says at the Loma Linda VA Medical Center veterans still had to use the information desk to find out exactly where they needed to go. “Now it’s almost perfect,” he says, “because it provides all the necessary information.” Deanna Callahan, innovation specialist and National Program Manager for VEText, says before VEText, the VA was relying on phone calls, robocalls, and mail. “We wanted to modernize our efforts to not only bring text message appointment reminders but go above and beyond and positively affect the No Show rate.” It worked—the No Show rate has dropped from 13.7% to 11.7% in the year the program has been active.

The system automatically enrolls veterans based on phone information already on file, but they can opt out by replying STOP to a reminder. Accidentally opting out is easily reversed by replying START to a previous reminder. Reminders are sent for clinical appointments at local medical centers and outpatient clinics, but not for Lab, Community Care, Research, Telephone Clinics, or Home-based Primary Care. (The reminders are additional—they do not replace letters, postcards, or automated phone call reminders.) VEText itself does not cost the veteran anything, but text messaging rates may apply, depending on individual cell phone plans. For more information, go to www.va.gov/HEALTH/vetext_faqs.asp.

Nearly 6 million veterans get health care scheduling reminders via VEText, an interactive mobile program launched a year ago. More than 70 million text messages later, how is VEText doing? Apparently, well. The VA says an “overwhelming majority” of veterans like the enhanced access. Only 4% have opted out.

The VA has worked to improve the user experience along the way. The latest enhancement allows the VA to send facility and clinic location in the unsecured text message appointment reminders. One user, James Preston, interviewed for a VA article, says at the Loma Linda VA Medical Center veterans still had to use the information desk to find out exactly where they needed to go. “Now it’s almost perfect,” he says, “because it provides all the necessary information.” Deanna Callahan, innovation specialist and National Program Manager for VEText, says before VEText, the VA was relying on phone calls, robocalls, and mail. “We wanted to modernize our efforts to not only bring text message appointment reminders but go above and beyond and positively affect the No Show rate.” It worked—the No Show rate has dropped from 13.7% to 11.7% in the year the program has been active.

The system automatically enrolls veterans based on phone information already on file, but they can opt out by replying STOP to a reminder. Accidentally opting out is easily reversed by replying START to a previous reminder. Reminders are sent for clinical appointments at local medical centers and outpatient clinics, but not for Lab, Community Care, Research, Telephone Clinics, or Home-based Primary Care. (The reminders are additional—they do not replace letters, postcards, or automated phone call reminders.) VEText itself does not cost the veteran anything, but text messaging rates may apply, depending on individual cell phone plans. For more information, go to www.va.gov/HEALTH/vetext_faqs.asp.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 03/13/2019 - 14:45
Un-Gate On Date
Wed, 03/13/2019 - 14:45
Use ProPublica
CFC Schedule Remove Status
Wed, 03/13/2019 - 14:45
Hide sidebar & use full width
render the right sidebar.

When a Public Health Alert Goes Wrong

Article Type
Changed
Wed, 03/27/2019 - 11:39
After a mishap with the Hawaii emergency alert system in 2018, an analysis was done on the efficacy of government alerts vs social media in times of crisis.

At 8:07 am on January 13, 2018, people in Hawaii received an emergency alert advising them to seek shelter from an incoming ballistic missile.

A very long 38 minutes later, the message was retracted via the same systems that had sent it—the Wireless Emergency Alert system, which sends location-based warnings to wireless carrier systems, and the Emergency Alert System, which sends television and radio alerts.

The Federal Communications Commission report that covered the debacle noted that, among other errors, the employee responsible for triggering the false alert believed the missile threat was real. Moreover, the exercise plans did not document a process for disseminating an all-clear message. And on top of that, the established ballistic missile alert checklist did not include a step to notify the Hawaii Emergency Management Agency’s public information officer responsible for communicating with the public, media, other agencies, and other stakeholders during an incident.

Researchers from the CDC and Hawaii Department of Health analyzed tweets sent during 2 periods: early (8:07-8:45 am), the 38 minutes during which the alert circulated; and the late period (8:46-9:24 am), the same amount of elapsed time after the correction had been issued.

They found 4 themes dominated the early period: information processing, information sharing, authentication, and emotional reaction (shock, fear, panic, terror). Information processing was defined as any indication of initial mental processing of the alert. Many of the tweets dealt with coming to terms with the threat.

During the late period, information sharing and emotional reaction persisted, but they were joined by new themes that, according to the researchers, were “fundamentally different” from the early-period themes and reflected reactions to misinformation: denunciation, insufficient knowledge to act, and mistrust of authority. “Insufficient knowledge to act” involved reacting to the lack of a response plan, particularly not knowing how to properly take shelter. Denunciations blamed the emergency warning and response, especially the time it took to correct the mistake. Mistrust of authority involved doubting the emergency alert system or governmental response.

How can a situation like this be better handled? The researchers say public health messaging during an emergency is complicated. For instance, it is influenced by how messages are perceived and interpreted by different people, and by the fact that messages need to be sent over multiple platforms to ensure that the information is disseminated accurately and quickly.

Which is why social media is both a handicap and a boon in public health emergencies. Tweets spread misinformation as fast as information (if not faster), so the first messages are critical. In addition to conveying timely messages, the researchers advise, public health authorities need to address the reactions during each phase of a crisis. They also need to establish credibility to prevent the public from mistrusting the public health message and its issuers.

Most important, perhaps: Alerts should carry clear instructions for persons in the affected area to carry out during an emergency.

Publications
Topics
Sections
After a mishap with the Hawaii emergency alert system in 2018, an analysis was done on the efficacy of government alerts vs social media in times of crisis.
After a mishap with the Hawaii emergency alert system in 2018, an analysis was done on the efficacy of government alerts vs social media in times of crisis.

At 8:07 am on January 13, 2018, people in Hawaii received an emergency alert advising them to seek shelter from an incoming ballistic missile.

A very long 38 minutes later, the message was retracted via the same systems that had sent it—the Wireless Emergency Alert system, which sends location-based warnings to wireless carrier systems, and the Emergency Alert System, which sends television and radio alerts.

The Federal Communications Commission report that covered the debacle noted that, among other errors, the employee responsible for triggering the false alert believed the missile threat was real. Moreover, the exercise plans did not document a process for disseminating an all-clear message. And on top of that, the established ballistic missile alert checklist did not include a step to notify the Hawaii Emergency Management Agency’s public information officer responsible for communicating with the public, media, other agencies, and other stakeholders during an incident.

Researchers from the CDC and Hawaii Department of Health analyzed tweets sent during 2 periods: early (8:07-8:45 am), the 38 minutes during which the alert circulated; and the late period (8:46-9:24 am), the same amount of elapsed time after the correction had been issued.

They found 4 themes dominated the early period: information processing, information sharing, authentication, and emotional reaction (shock, fear, panic, terror). Information processing was defined as any indication of initial mental processing of the alert. Many of the tweets dealt with coming to terms with the threat.

During the late period, information sharing and emotional reaction persisted, but they were joined by new themes that, according to the researchers, were “fundamentally different” from the early-period themes and reflected reactions to misinformation: denunciation, insufficient knowledge to act, and mistrust of authority. “Insufficient knowledge to act” involved reacting to the lack of a response plan, particularly not knowing how to properly take shelter. Denunciations blamed the emergency warning and response, especially the time it took to correct the mistake. Mistrust of authority involved doubting the emergency alert system or governmental response.

How can a situation like this be better handled? The researchers say public health messaging during an emergency is complicated. For instance, it is influenced by how messages are perceived and interpreted by different people, and by the fact that messages need to be sent over multiple platforms to ensure that the information is disseminated accurately and quickly.

Which is why social media is both a handicap and a boon in public health emergencies. Tweets spread misinformation as fast as information (if not faster), so the first messages are critical. In addition to conveying timely messages, the researchers advise, public health authorities need to address the reactions during each phase of a crisis. They also need to establish credibility to prevent the public from mistrusting the public health message and its issuers.

Most important, perhaps: Alerts should carry clear instructions for persons in the affected area to carry out during an emergency.

At 8:07 am on January 13, 2018, people in Hawaii received an emergency alert advising them to seek shelter from an incoming ballistic missile.

A very long 38 minutes later, the message was retracted via the same systems that had sent it—the Wireless Emergency Alert system, which sends location-based warnings to wireless carrier systems, and the Emergency Alert System, which sends television and radio alerts.

The Federal Communications Commission report that covered the debacle noted that, among other errors, the employee responsible for triggering the false alert believed the missile threat was real. Moreover, the exercise plans did not document a process for disseminating an all-clear message. And on top of that, the established ballistic missile alert checklist did not include a step to notify the Hawaii Emergency Management Agency’s public information officer responsible for communicating with the public, media, other agencies, and other stakeholders during an incident.

Researchers from the CDC and Hawaii Department of Health analyzed tweets sent during 2 periods: early (8:07-8:45 am), the 38 minutes during which the alert circulated; and the late period (8:46-9:24 am), the same amount of elapsed time after the correction had been issued.

They found 4 themes dominated the early period: information processing, information sharing, authentication, and emotional reaction (shock, fear, panic, terror). Information processing was defined as any indication of initial mental processing of the alert. Many of the tweets dealt with coming to terms with the threat.

During the late period, information sharing and emotional reaction persisted, but they were joined by new themes that, according to the researchers, were “fundamentally different” from the early-period themes and reflected reactions to misinformation: denunciation, insufficient knowledge to act, and mistrust of authority. “Insufficient knowledge to act” involved reacting to the lack of a response plan, particularly not knowing how to properly take shelter. Denunciations blamed the emergency warning and response, especially the time it took to correct the mistake. Mistrust of authority involved doubting the emergency alert system or governmental response.

How can a situation like this be better handled? The researchers say public health messaging during an emergency is complicated. For instance, it is influenced by how messages are perceived and interpreted by different people, and by the fact that messages need to be sent over multiple platforms to ensure that the information is disseminated accurately and quickly.

Which is why social media is both a handicap and a boon in public health emergencies. Tweets spread misinformation as fast as information (if not faster), so the first messages are critical. In addition to conveying timely messages, the researchers advise, public health authorities need to address the reactions during each phase of a crisis. They also need to establish credibility to prevent the public from mistrusting the public health message and its issuers.

Most important, perhaps: Alerts should carry clear instructions for persons in the affected area to carry out during an emergency.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Thu, 03/07/2019 - 08:45
Un-Gate On Date
Thu, 03/07/2019 - 08:45
Use ProPublica
CFC Schedule Remove Status
Thu, 03/07/2019 - 08:45
Hide sidebar & use full width
render the right sidebar.

PTSD and Emotional Eating

Article Type
Changed
Tue, 04/02/2019 - 12:02
Could emotional eating caused by PTSD be connected with the high obesity rate among veterans?

Nearly 80% of veterans are overweight or obese. According to researchers from Walter Reed National Military Medical Center in Maryland and Yale School of Medicine in Connecticut, obesity is more common among veterans with posttraumatic stress disorder (PTSD) compared with that in other veterans in the VHA (47% vs 41%). Moreover, they say, veterans with PTSD lose less weight during weight-loss treatment than do those without comorbid mental health conditions. PTSD also has been associated with night eating, food addiction, binge eating, and eating as a coping strategy. In a national survey, veterans who self-reported a diagnosis of PTSD were more likely to endorse eating because of emotions or stress.

The researchers conducted a study of 126 veterans referred to the MOVE! Weight Management Program at VA Connecticut Healthcare System. Although it replicates and extends findings from other studies, they believe theirs is the first study examining emotional eating among veterans seeking obesity treatment.

The veterans were given the Yale Emotional Overeating Questionnaire (YEOQ), which assesses how often the respondent has eaten an unusually large amount of food in response to anxiety, sadness, loneliness, tiredness, anger, happiness, boredom, guilt, and physical pain. The researchers also used the Primary Care PTSD Screen to test for PTSD.

A positive PTSD screen was associated with significantly higher scores on the YEOQ overall as well as higher scores on each individual item. Higher scores on the PTSD screen also were associated with more frequent emotional eating for all emotions.

The researchers note that findings about the predictive validity of emotional eating questionnaires have been mixed. Although emotions may influence eating patterns, other mechanisms could be at work, such as general concern about, or lack of control over, eating.

However, the researchers suggest that veterans with PTSD may need specific attention given to alternative coping strategies when facing difficult emotions as part of weight loss treatment.

 

Publications
Topics
Sections
Could emotional eating caused by PTSD be connected with the high obesity rate among veterans?
Could emotional eating caused by PTSD be connected with the high obesity rate among veterans?

Nearly 80% of veterans are overweight or obese. According to researchers from Walter Reed National Military Medical Center in Maryland and Yale School of Medicine in Connecticut, obesity is more common among veterans with posttraumatic stress disorder (PTSD) compared with that in other veterans in the VHA (47% vs 41%). Moreover, they say, veterans with PTSD lose less weight during weight-loss treatment than do those without comorbid mental health conditions. PTSD also has been associated with night eating, food addiction, binge eating, and eating as a coping strategy. In a national survey, veterans who self-reported a diagnosis of PTSD were more likely to endorse eating because of emotions or stress.

The researchers conducted a study of 126 veterans referred to the MOVE! Weight Management Program at VA Connecticut Healthcare System. Although it replicates and extends findings from other studies, they believe theirs is the first study examining emotional eating among veterans seeking obesity treatment.

The veterans were given the Yale Emotional Overeating Questionnaire (YEOQ), which assesses how often the respondent has eaten an unusually large amount of food in response to anxiety, sadness, loneliness, tiredness, anger, happiness, boredom, guilt, and physical pain. The researchers also used the Primary Care PTSD Screen to test for PTSD.

A positive PTSD screen was associated with significantly higher scores on the YEOQ overall as well as higher scores on each individual item. Higher scores on the PTSD screen also were associated with more frequent emotional eating for all emotions.

The researchers note that findings about the predictive validity of emotional eating questionnaires have been mixed. Although emotions may influence eating patterns, other mechanisms could be at work, such as general concern about, or lack of control over, eating.

However, the researchers suggest that veterans with PTSD may need specific attention given to alternative coping strategies when facing difficult emotions as part of weight loss treatment.

 

Nearly 80% of veterans are overweight or obese. According to researchers from Walter Reed National Military Medical Center in Maryland and Yale School of Medicine in Connecticut, obesity is more common among veterans with posttraumatic stress disorder (PTSD) compared with that in other veterans in the VHA (47% vs 41%). Moreover, they say, veterans with PTSD lose less weight during weight-loss treatment than do those without comorbid mental health conditions. PTSD also has been associated with night eating, food addiction, binge eating, and eating as a coping strategy. In a national survey, veterans who self-reported a diagnosis of PTSD were more likely to endorse eating because of emotions or stress.

The researchers conducted a study of 126 veterans referred to the MOVE! Weight Management Program at VA Connecticut Healthcare System. Although it replicates and extends findings from other studies, they believe theirs is the first study examining emotional eating among veterans seeking obesity treatment.

The veterans were given the Yale Emotional Overeating Questionnaire (YEOQ), which assesses how often the respondent has eaten an unusually large amount of food in response to anxiety, sadness, loneliness, tiredness, anger, happiness, boredom, guilt, and physical pain. The researchers also used the Primary Care PTSD Screen to test for PTSD.

A positive PTSD screen was associated with significantly higher scores on the YEOQ overall as well as higher scores on each individual item. Higher scores on the PTSD screen also were associated with more frequent emotional eating for all emotions.

The researchers note that findings about the predictive validity of emotional eating questionnaires have been mixed. Although emotions may influence eating patterns, other mechanisms could be at work, such as general concern about, or lack of control over, eating.

However, the researchers suggest that veterans with PTSD may need specific attention given to alternative coping strategies when facing difficult emotions as part of weight loss treatment.

 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Fri, 02/01/2019 - 12:30
Un-Gate On Date
Fri, 02/01/2019 - 12:30
Use ProPublica
CFC Schedule Remove Status
Fri, 02/01/2019 - 12:30
Hide sidebar & use full width
render the right sidebar.

FDA Approves Rescue Drug for Chemotherapy Overdose

Article Type
Changed
Thu, 12/15/2022 - 14:59
Display Headline
FDA Approves Rescue Drug for Chemotherapy Overdose
Uridine triacetate helps protect against cell damage and cell death associated with chemotherapy.

The FDA has approved uridine triacetate (Vistogard), a first-of-its-kind rescue drug for overdose toxicity of the chemotherapy drugs 5-fluorouracil or capecitabine.

Such overdoses, which are rare but can be fatal, may happen if a patient receives the drug at a dose or rate greater than intended or if a patient has genetic variations, impaired clearance, or other factors that increase susceptibility to the drug’s toxicities. Uridine triacetate blocks cell damage and cell death caused by the chemotherapy.

Related: Delayed Adjuvant Chemotherapy Significantly Affects Breast Cancer Recovery

Two trials examined efficacy and safety of 135 adults and pediatric cancer patients; 117 had received an overdose of fluorouracil or capecitabine by rate (1.3 to 720 times the infusion rate), by dose, or by both dose and rate. The remaining 18 had early-onset, unusually severe, or life-threatening toxicities within 96 hours of receiving fluorouracil. The toxicities involved the central nervous system (such as acute mental status change), cardiovascular system, gastrointestinal system (eg, mucositis), and bone marrow.

The studies’ main measure was survival at 30 days or resumption of chemotherapy before 30 days. Patients received a single course of 10 grams orally every 6 hours for 20 doses (dose was adjusted for patients aged 1 to 7 years).

Related: New Treatments for Chronic Lymphocytic Leukemia

Five patients died of fluorouracil or capecitabine toxicity. Of those treated for overdose, 97% were still alive at 30 days. Of those treated for early-onset toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in fewer than 30 days. By contrast, in retrospective historical reports, 84% of 25 patients who received only supportive care for 5-FU overdose (all overdosed with 1.9 to 64 times the planned infusion rate) died.

Related: Evaluating Sorafenib in Veterans With Advanced Hepatocellular Carcinoma

Uridine triacetate is not recommended for treating nonemergency adverse effects (AEs) associated with fluorouracil or capecitabine, because it could lessen their effectiveness. The most common AEs of treatment with uridine triacetate were diarrhea, vomiting, and nausea.

Sources: U.S. Food and Drug Administration. FDA approves first emergency treatment for overdose of certain types of chemotherapy [news release]. Silver Springs, MD: U.S. Food and Drug Administration Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476919.htm. Updated December 11, 2015. Accessed January 28, 2016.

Vistogard [package insert]. Gaithersburg, MD: Wellstat Therapeutics; 2015.

Publications
Topics
Legacy Keywords
Vistogard, chemotherapy overdose, pediatric cancer patients, fluorouracil, capecitabine, uridine triacetate, Wellstate Therapeutics Corporation
Sections
Related Articles
Uridine triacetate helps protect against cell damage and cell death associated with chemotherapy.
Uridine triacetate helps protect against cell damage and cell death associated with chemotherapy.

The FDA has approved uridine triacetate (Vistogard), a first-of-its-kind rescue drug for overdose toxicity of the chemotherapy drugs 5-fluorouracil or capecitabine.

Such overdoses, which are rare but can be fatal, may happen if a patient receives the drug at a dose or rate greater than intended or if a patient has genetic variations, impaired clearance, or other factors that increase susceptibility to the drug’s toxicities. Uridine triacetate blocks cell damage and cell death caused by the chemotherapy.

Related: Delayed Adjuvant Chemotherapy Significantly Affects Breast Cancer Recovery

Two trials examined efficacy and safety of 135 adults and pediatric cancer patients; 117 had received an overdose of fluorouracil or capecitabine by rate (1.3 to 720 times the infusion rate), by dose, or by both dose and rate. The remaining 18 had early-onset, unusually severe, or life-threatening toxicities within 96 hours of receiving fluorouracil. The toxicities involved the central nervous system (such as acute mental status change), cardiovascular system, gastrointestinal system (eg, mucositis), and bone marrow.

The studies’ main measure was survival at 30 days or resumption of chemotherapy before 30 days. Patients received a single course of 10 grams orally every 6 hours for 20 doses (dose was adjusted for patients aged 1 to 7 years).

Related: New Treatments for Chronic Lymphocytic Leukemia

Five patients died of fluorouracil or capecitabine toxicity. Of those treated for overdose, 97% were still alive at 30 days. Of those treated for early-onset toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in fewer than 30 days. By contrast, in retrospective historical reports, 84% of 25 patients who received only supportive care for 5-FU overdose (all overdosed with 1.9 to 64 times the planned infusion rate) died.

Related: Evaluating Sorafenib in Veterans With Advanced Hepatocellular Carcinoma

Uridine triacetate is not recommended for treating nonemergency adverse effects (AEs) associated with fluorouracil or capecitabine, because it could lessen their effectiveness. The most common AEs of treatment with uridine triacetate were diarrhea, vomiting, and nausea.

Sources: U.S. Food and Drug Administration. FDA approves first emergency treatment for overdose of certain types of chemotherapy [news release]. Silver Springs, MD: U.S. Food and Drug Administration Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476919.htm. Updated December 11, 2015. Accessed January 28, 2016.

Vistogard [package insert]. Gaithersburg, MD: Wellstat Therapeutics; 2015.

The FDA has approved uridine triacetate (Vistogard), a first-of-its-kind rescue drug for overdose toxicity of the chemotherapy drugs 5-fluorouracil or capecitabine.

Such overdoses, which are rare but can be fatal, may happen if a patient receives the drug at a dose or rate greater than intended or if a patient has genetic variations, impaired clearance, or other factors that increase susceptibility to the drug’s toxicities. Uridine triacetate blocks cell damage and cell death caused by the chemotherapy.

Related: Delayed Adjuvant Chemotherapy Significantly Affects Breast Cancer Recovery

Two trials examined efficacy and safety of 135 adults and pediatric cancer patients; 117 had received an overdose of fluorouracil or capecitabine by rate (1.3 to 720 times the infusion rate), by dose, or by both dose and rate. The remaining 18 had early-onset, unusually severe, or life-threatening toxicities within 96 hours of receiving fluorouracil. The toxicities involved the central nervous system (such as acute mental status change), cardiovascular system, gastrointestinal system (eg, mucositis), and bone marrow.

The studies’ main measure was survival at 30 days or resumption of chemotherapy before 30 days. Patients received a single course of 10 grams orally every 6 hours for 20 doses (dose was adjusted for patients aged 1 to 7 years).

Related: New Treatments for Chronic Lymphocytic Leukemia

Five patients died of fluorouracil or capecitabine toxicity. Of those treated for overdose, 97% were still alive at 30 days. Of those treated for early-onset toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in fewer than 30 days. By contrast, in retrospective historical reports, 84% of 25 patients who received only supportive care for 5-FU overdose (all overdosed with 1.9 to 64 times the planned infusion rate) died.

Related: Evaluating Sorafenib in Veterans With Advanced Hepatocellular Carcinoma

Uridine triacetate is not recommended for treating nonemergency adverse effects (AEs) associated with fluorouracil or capecitabine, because it could lessen their effectiveness. The most common AEs of treatment with uridine triacetate were diarrhea, vomiting, and nausea.

Sources: U.S. Food and Drug Administration. FDA approves first emergency treatment for overdose of certain types of chemotherapy [news release]. Silver Springs, MD: U.S. Food and Drug Administration Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476919.htm. Updated December 11, 2015. Accessed January 28, 2016.

Vistogard [package insert]. Gaithersburg, MD: Wellstat Therapeutics; 2015.

Publications
Publications
Topics
Article Type
Display Headline
FDA Approves Rescue Drug for Chemotherapy Overdose
Display Headline
FDA Approves Rescue Drug for Chemotherapy Overdose
Legacy Keywords
Vistogard, chemotherapy overdose, pediatric cancer patients, fluorouracil, capecitabine, uridine triacetate, Wellstate Therapeutics Corporation
Legacy Keywords
Vistogard, chemotherapy overdose, pediatric cancer patients, fluorouracil, capecitabine, uridine triacetate, Wellstate Therapeutics Corporation
Sections
Disallow All Ads
Alternative CME
Use ProPublica