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CDC provides update on vaping-related injuries

Anne Schuchat
Anne Schuchat

As of Oct. 8, 1,299 confirmed and probable cases of lung injury associated with electronic cigarette use, or vaping, have been reported by 49 states, the District of Columbia and the U.S. Virgin Islands. There have also been 26 deaths confirmed and reported to CDC from 21 states, including a death in a patient aged only 17 years, Anne Schuchat, MD, CDC principal deputy director said during a telebriefing on Oct. 11.

At present, Alaska remains the only state unaffected by the outbreak, she added.

Consistent with the case definition, all reported patients have a history of using e-cigarette or vaping products. Previously reported trends also continue to persist, according to Schuchat.

Among 573 patients with available information on substances used in e-cigarettes in the 90 days before symptom onset:

  • 76% reported using tetrahydrocannabinol (THC)-containing products with or without nicotine-containing products;
  • 32% reported exclusive use of THC-containing products;
  • 58% reporting using nicotine-containing products, with or without THC-containing products; and
  • 13% reported exclusive use of nicotine-containing products.

Among 1,043 patients with data on age and sex:

  • 70% of patients are male;
  • 80% of patients are aged younger than 35 years;
  • 26% are aged 25 to 34 years; and
  • 15% are aged younger than 18 years.

Among the 26 patients who died, the median age is 49 years, ranging from ages 17 to 75 years.

 
As of Oct. 8, 1,299 confirmed and probable cases of lung injury associated with electronic cigarette use, or vaping, have been reported by 49 states, the District of Columbia and the U.S. Virgin Islands.
Source: Adobe Stock

“Although THC-containing products appear to be implicated in these injuries, the specific exposures responsible for the lung injuries have not been identified, nor have nicotine-containing products been excluded as a possible cause,” Schuchat said during the Oct. 11 briefing.

She added, though, that national findings suggest that products containing THC, particularly those obtained off the street or from unknown sources, are linked to most of the cases and play a major role in the outbreak. As such, CDC recommends against the use of e-cigarette or vaping products that contain THC and advises people to reconsider use of all e-cigarette or vaping products until the investigation into the outbreak has concluded.

Updated guidance for clinicians

CDC has also updated its interim clinical guidance to provide clinicians with a framework for the initial assessment, evaluation, management and follow-up of people with symptoms of lung injury associated with e-cigarette, or vaping, products. The guidance also contains suggested criteria for hospital admission and treatment, more specific information on timelines, including for patients who have been discharged, special considerations for high-risk groups, and clinical and public health recommendations.

The updated guidance, which was published on Oct. 11 in MMWR, also advises close follow-up of patients with what the CDC has now dubbed “e-cigarette- or vaping-associated lung injury” (EVALI), as some patients who initially had mild symptoms experienced a rapid worsening of symptoms within 48 hours.

The MMWR report also describes national surveillance data on clinical features of recently reported cases. Among 339 patients for whom data have been submitted to CDC:

  • 95% initially experienced respiratory symptoms such as cough, chest pain or shortness of breath;
  • 77% have gastrointestinal symptoms such as abdominal pain, nausea, vomiting and diarrhea;
  • 47% required transfer to ICUs; and
  • 22% required mechanical ventilation.

Of the 339 patients, 80 were aged younger than 18 years, of whom 56% were cared for in the ICU and 29% were intubated and required mechanical ventilation.

In terms of treatment, of 287 patients for whom CDC has information, 88% received treatment with corticosteroids. Follow-up information was available for only 140 patients, with 82% reporting improvement.

“We don’t know how many of these patients might have improved without corticosteroid treatment and we don’t know yet whether there are negative consequences like worsening infection risk for treatment with corticosteroids,” Schuchat said during the Oct. 11 telebriefing.

She also noted that CDC has added guidance about the importance of addressing patients’ need to avoid e-cigarette or vaping product use during and after their hospitalizations, as clinicians have alerted CDC to concern that patients treated for a lung injury who resumed the use of e-cigarette or vaping product might experience a recurrence or worsening of symptoms of lung injury.

Currently, there have been less than five recurrences reported, with the time for readmission ranging from 5 to up to 55 days after hospital discharge, according to Schuchat.

“The issue of readmissions is a relatively new consideration in the outbreak,” she said on Oct. 11. “We haven’t systematically asked about it and are just beginning to. We have updated the case report form and are trying to capture new information.”

In light of this information, CDC recommends that follow-up occur within 24 to 48 hours in the outpatient setting and within 1 to 2 weeks after hospital discharge.

Schuchat also said that the National Center for Health Statistics is working to develop ICD-10 coding so clinical episodes and fatalities that have this condition can be linked systematically.

FDA efforts

During the Oct. 11 telebriefing, Norman “Ned” E. Sharpless, MD, acting commissioner of the FDA, and Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, provided an update on the agency’s actions in investigating the outbreak.

“Our staff are using state-of-the-art methods to assess the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, metals, cutting agents and other additives, pesticides and other toxins,” Sharpless said.

Currently, the FDA has collected 725 samples of e-cigarette or vaping products, including product labels, devices, products containing liquid and used containers, for lab testing from 23 states and the U.S. Virgin Islands. The FDA has been able to initiate testing for more than 300 samples from 18 states and the U.S. Virgin Islands. Of these samples, analysis has begun for 79 nicotine-containing products and 225 THC-containing products, according to Zeller.

For the first 28 samples in which researchers have been able to assess THC, THC concentrations have ranged from 13% to 77%, with a mean concentration of 41%. They have also found the presence of vitamin E acetate, which is thought to be some type of cutting or diluting agent, in the first 37 samples where they have been able to assess the concentration of vitamin E acetate, with concentrations ranging from 23% to 88% and a mean concentration of 50%. So far, vitamin E acetate has been detected in 47% of THC products for which analysis has begun.

“Based on our testing of samples to date, there does not appear to be one product or substance involved in all of the cases, and it may be that there is more than one cause to this outbreak,” Sharpless said. “We do know that THC is present in most of the samples tested to date, which is why the FDA issued an updated consumer safety alert [in early October] warning consumers not to use vaping products that contain THC and not to modify or add any substances including THC or other oils to vaping products. However, the investigation is not limited to THC.”

As Healio Pulmonology previously reported, CDC and the FDA have scaled up their efforts, which includes involvement of the FDA’s Office of Criminal Investigations. During today’s telebriefing, Sharpless also said that the agency is working with the Drug Enforcement Agency as well as customs and border patrol agents regarding potentially illicit vaping products at potential entry locations.

“I want to stress that the FDA is focused on identifying the products that are making people ill and following the supply chain to its source. FDA is focused on identifying the products that are making people ill and following the supply chain to its source,” Sharpless said during the Oct. 11 telebriefing. “FDA is not pursuing any enforcement actions associated with personal use of any vaping products. Our interest is in the supply chain. As I said before, if we determine that someone is manufacturing or distributing illicit adulterated vaping products that cause illness or death for personal profit, we would consider that to be a criminal act. Getting to the bottom of these respiratory illnesses is a top priority for all the state and federal agencies involved and we’re committed to taking appropriate action as the facts emerge.”by Melissa Foster

Reference:

Siegel DA, et al. MMWR Morb Mortal Wkly Rep. 2019;doi:http://dx.doi.org/10.15585/mmwr.mm6841e3.

Editor’s note: This article was updated on Oct. 10 to include new information from CDC on the number of reported cases and deaths. This article was updated on Oct. 11 to reflect comments made during a CDC telebriefing.

Anne Schuchat
Anne Schuchat

As of Oct. 8, 1,299 confirmed and probable cases of lung injury associated with electronic cigarette use, or vaping, have been reported by 49 states, the District of Columbia and the U.S. Virgin Islands. There have also been 26 deaths confirmed and reported to CDC from 21 states, including a death in a patient aged only 17 years, Anne Schuchat, MD, CDC principal deputy director said during a telebriefing on Oct. 11.

At present, Alaska remains the only state unaffected by the outbreak, she added.

Consistent with the case definition, all reported patients have a history of using e-cigarette or vaping products. Previously reported trends also continue to persist, according to Schuchat.

Among 573 patients with available information on substances used in e-cigarettes in the 90 days before symptom onset:

  • 76% reported using tetrahydrocannabinol (THC)-containing products with or without nicotine-containing products;
  • 32% reported exclusive use of THC-containing products;
  • 58% reporting using nicotine-containing products, with or without THC-containing products; and
  • 13% reported exclusive use of nicotine-containing products.

Among 1,043 patients with data on age and sex:

  • 70% of patients are male;
  • 80% of patients are aged younger than 35 years;
  • 26% are aged 25 to 34 years; and
  • 15% are aged younger than 18 years.

Among the 26 patients who died, the median age is 49 years, ranging from ages 17 to 75 years.

 
As of Oct. 8, 1,299 confirmed and probable cases of lung injury associated with electronic cigarette use, or vaping, have been reported by 49 states, the District of Columbia and the U.S. Virgin Islands.
Source: Adobe Stock

“Although THC-containing products appear to be implicated in these injuries, the specific exposures responsible for the lung injuries have not been identified, nor have nicotine-containing products been excluded as a possible cause,” Schuchat said during the Oct. 11 briefing.

She added, though, that national findings suggest that products containing THC, particularly those obtained off the street or from unknown sources, are linked to most of the cases and play a major role in the outbreak. As such, CDC recommends against the use of e-cigarette or vaping products that contain THC and advises people to reconsider use of all e-cigarette or vaping products until the investigation into the outbreak has concluded.

Updated guidance for clinicians

CDC has also updated its interim clinical guidance to provide clinicians with a framework for the initial assessment, evaluation, management and follow-up of people with symptoms of lung injury associated with e-cigarette, or vaping, products. The guidance also contains suggested criteria for hospital admission and treatment, more specific information on timelines, including for patients who have been discharged, special considerations for high-risk groups, and clinical and public health recommendations.

The updated guidance, which was published on Oct. 11 in MMWR, also advises close follow-up of patients with what the CDC has now dubbed “e-cigarette- or vaping-associated lung injury” (EVALI), as some patients who initially had mild symptoms experienced a rapid worsening of symptoms within 48 hours.

The MMWR report also describes national surveillance data on clinical features of recently reported cases. Among 339 patients for whom data have been submitted to CDC:

  • 95% initially experienced respiratory symptoms such as cough, chest pain or shortness of breath;
  • 77% have gastrointestinal symptoms such as abdominal pain, nausea, vomiting and diarrhea;
  • 47% required transfer to ICUs; and
  • 22% required mechanical ventilation.

Of the 339 patients, 80 were aged younger than 18 years, of whom 56% were cared for in the ICU and 29% were intubated and required mechanical ventilation.

In terms of treatment, of 287 patients for whom CDC has information, 88% received treatment with corticosteroids. Follow-up information was available for only 140 patients, with 82% reporting improvement.

“We don’t know how many of these patients might have improved without corticosteroid treatment and we don’t know yet whether there are negative consequences like worsening infection risk for treatment with corticosteroids,” Schuchat said during the Oct. 11 telebriefing.

She also noted that CDC has added guidance about the importance of addressing patients’ need to avoid e-cigarette or vaping product use during and after their hospitalizations, as clinicians have alerted CDC to concern that patients treated for a lung injury who resumed the use of e-cigarette or vaping product might experience a recurrence or worsening of symptoms of lung injury.

Currently, there have been less than five recurrences reported, with the time for readmission ranging from 5 to up to 55 days after hospital discharge, according to Schuchat.

“The issue of readmissions is a relatively new consideration in the outbreak,” she said on Oct. 11. “We haven’t systematically asked about it and are just beginning to. We have updated the case report form and are trying to capture new information.”

In light of this information, CDC recommends that follow-up occur within 24 to 48 hours in the outpatient setting and within 1 to 2 weeks after hospital discharge.

Schuchat also said that the National Center for Health Statistics is working to develop ICD-10 coding so clinical episodes and fatalities that have this condition can be linked systematically.

FDA efforts

During the Oct. 11 telebriefing, Norman “Ned” E. Sharpless, MD, acting commissioner of the FDA, and Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, provided an update on the agency’s actions in investigating the outbreak.

“Our staff are using state-of-the-art methods to assess the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, metals, cutting agents and other additives, pesticides and other toxins,” Sharpless said.

Currently, the FDA has collected 725 samples of e-cigarette or vaping products, including product labels, devices, products containing liquid and used containers, for lab testing from 23 states and the U.S. Virgin Islands. The FDA has been able to initiate testing for more than 300 samples from 18 states and the U.S. Virgin Islands. Of these samples, analysis has begun for 79 nicotine-containing products and 225 THC-containing products, according to Zeller.

For the first 28 samples in which researchers have been able to assess THC, THC concentrations have ranged from 13% to 77%, with a mean concentration of 41%. They have also found the presence of vitamin E acetate, which is thought to be some type of cutting or diluting agent, in the first 37 samples where they have been able to assess the concentration of vitamin E acetate, with concentrations ranging from 23% to 88% and a mean concentration of 50%. So far, vitamin E acetate has been detected in 47% of THC products for which analysis has begun.

“Based on our testing of samples to date, there does not appear to be one product or substance involved in all of the cases, and it may be that there is more than one cause to this outbreak,” Sharpless said. “We do know that THC is present in most of the samples tested to date, which is why the FDA issued an updated consumer safety alert [in early October] warning consumers not to use vaping products that contain THC and not to modify or add any substances including THC or other oils to vaping products. However, the investigation is not limited to THC.”

As Healio Pulmonology previously reported, CDC and the FDA have scaled up their efforts, which includes involvement of the FDA’s Office of Criminal Investigations. During today’s telebriefing, Sharpless also said that the agency is working with the Drug Enforcement Agency as well as customs and border patrol agents regarding potentially illicit vaping products at potential entry locations.

“I want to stress that the FDA is focused on identifying the products that are making people ill and following the supply chain to its source. FDA is focused on identifying the products that are making people ill and following the supply chain to its source,” Sharpless said during the Oct. 11 telebriefing. “FDA is not pursuing any enforcement actions associated with personal use of any vaping products. Our interest is in the supply chain. As I said before, if we determine that someone is manufacturing or distributing illicit adulterated vaping products that cause illness or death for personal profit, we would consider that to be a criminal act. Getting to the bottom of these respiratory illnesses is a top priority for all the state and federal agencies involved and we’re committed to taking appropriate action as the facts emerge.”by Melissa Foster

Reference:

Siegel DA, et al. MMWR Morb Mortal Wkly Rep. 2019;doi:http://dx.doi.org/10.15585/mmwr.mm6841e3.

Editor’s note: This article was updated on Oct. 10 to include new information from CDC on the number of reported cases and deaths. This article was updated on Oct. 11 to reflect comments made during a CDC telebriefing.