Tag Archives: regulator

EU regulator places no new restrictions on AstraZeneca vaccine due to ‘possible’ blood clot link

The European Union’s drug regulator says it has found a “possible link” between the AstraZeneca-Oxford coronavirus vaccine and a rare blood-clotting disorder, but the benefits of the shot and the potential health consequences of suffering from COVID-19 still outweigh any risks.

The European Medicines Agency (EMA) said it would place no new restrictions on using the vaccine in people 18 and over, in both a statement and a subsequent news conference on Wednesday.

The EMA said most of the cases reported have occurred in women under 60 within two weeks of vaccination. The agency said based on the currently available evidence, it was not able to identify specific risk factors.

“The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side-effects of the vaccine,” said Emer Cooke, the agency’s executive director.

Experts reviewed several dozen cases that came mainly from Europe and the United Kingdom, where around 25 million people have received the AstraZeneca-Oxford vaccine.

At a news conference from Brussels, Cooke said “the risk of mortality from COVID is much greater than the risk of mortality from these side-effects.”

Britain adjusts vaccine advice

The head of Britain’s drug regulator echoed that sentiment, but said on Wednesday people under 30 will be offered another product due to a rare blood clot risk.

The Pfizer-BioNTech and Moderna vaccines should be offered to people in that age group instead, the Medicines and Healthcare Products Regulatory Agency (MHRA) advised.

Dr. June Raine, the head of the MHRA, said the risk “remains extremely low” at “about four people in a million” who receive the shot.

WATCH | Britain’s Raine breaks down the number of cases:

The U.K.’s drug regulator says a rare side-effect from the AstraZeneca-Oxford COVID-19 vaccine has led to a change in its advice for what age groups should receive the shot. 1:33

Raine said that as of the end of March, there had been 79 reports, all after the first dose, out of approximately 20 million doses given within the U.K. Of the adverse reports, 51 came from women.

Raine said the British regulator had tracked 19 deaths among those reports, three of them in people under the age of 30. The regulator said the reports did not constitute proof that the inoculation had caused the clots.

Jonathan Van Tam, Britain’s deputy chief medical officer, characterized the new recommendation as a “course correction” not uncommon for the rollout of vaccines used in treating other illnesses.

“You can’t pick these kinds of things up until you’ve literally deployed tens of millions of vaccines,” he said.

According to reports in Britain, the majority of those under 30 have yet to be vaccinated.

In light of the follow up in Europe, the World Health Organization’s vaccine advisory committee said more specialized studies were needed into the blood clots.

“Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed,” the WHO committee said in a statement.

Canada already recommended shot for those 55 and over

The vaccine is one of five separate approvals so far during the pandemic from Health Canada, comprising two different sources.

Canada approved AstraZeneca-Oxford doses being manufactured in both Europe and in India, where it has been branded as Covishield. The vaccine first arrived in Canada in early March, and later that month, Ottawa announced it had received a loan from the United States of 1.5 million additional doses, as a hearing on the vaccine’s approval has yet to be held by American regulators.

Canada’s National Advisory Committee on Immunization (NACI) updated its recommendations in late March regarding the use of the AstraZeneca-Oxford vaccine in light of the blood clot reports seen in Europe. The committee recommended a pause in inoculating Canadians under 55 with that vaccine.

In its tracking of potential adverse events following vaccination, Health Canada has received no reports of the rare blood clotting in this country.

WATCH | Canada’s vaccine advisory committee adjusts AstraZeneca guidelines:

The European Medicines Agency says rare blood clots are a potential side effect of the AstraZeneca-Oxford COVID-19 vaccine, but it still says the benefits of the vaccine far outweigh the risks. 1:39

Dr. Shelley Deeks, co-chair of NACI, said at a virtual briefing on Tuesday that Canadian officials will study the updated data from their European counterparts to see if any advice needs to be updated.

She said it would be “premature” to say if the latest development in Europe will have any effect on confidence in the AstraZeneca-Oxford vaccine.

“What we’ve tried to be doing at NACI is actually being quite transparent about the evolution of the data so Canadians will have confidence that we are communicating what we know about safety, when we know it,” said Deeks.

The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It also evaluated reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding.

Raine said 14 of the 19 fatalities noted were cases where cerebral venous sinus thrombosis with low platelets was present, while the other cases were associated with other kinds of thrombosis in major veins.

As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected.

In March, more than a dozen countries, mostly in Europe, suspended their use of the AstraZeneca-Oxford vaccine over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.

WATCH | European Union regulator says blood clot risk extremely rare:

Canada’s vaccine advisory committee has changed its advice and now says the AstraZeneca COVID-19 vaccine should only be given to people aged 55 and up following concerns it could be linked to a rare blood clot. 2:21

The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people.

Cooke characterized the reports as evidence that caution and transparency have been guiding decisions.

“These very rare and unusual events were picked up, identified, analyzed and we have made a clear science-based recommendation to allow the safe and effective use of the vaccine,” she said.

Dr. Peter English, who formerly chaired the British Medical Association’s public health medicine committee, said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.

“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.

That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the United Nations-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

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EU’s health regulator approves 3 new vaccine manufacturing sites

The European Union’s medicines regulator on Friday said it has approved new manufacturing sites for coronavirus vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca-Oxford, in a move that could significantly boost Europe’s supply of the shots and speed vaccination efforts across the continent.

The European Medicines Agency said in a statement that it had approved sites in the Netherlands, Germany and Switzerland for the COVID-19 vaccines made by the companies.

The new approvals come amid the 27-nation bloc’s struggles to ramp up COVID-19 vaccination and repeated delivery delays and manufacturing problems.

The EMA said it had approved a factory in Leiden, the Netherlands, to make the active substance for AstraZeneca’s vaccine, bringing the number of such licensed sites to four.

The EU regulator said it was also giving the green light to a site in Marburg, Germany, to make both the active substance and completed vaccine developed by BioNTech and Pfizer.

In addition, the EMA said it was granting “more flexible storage conditions” to the Pfizer-BioNTech vaccine — which was cleared on the basis that it needed ultra-cold freezer temperatures for storage and delivery.

BioNTech said in a release that it expects the first batches of vaccines manufactured at the Marburg site will be delivered in the second half of April.

“Currently, 400 BioNTech employees work in Marburg, 200 of them in 24/7 shifts in order to maximize the production’s output,” the company said.

Supply, distribution remain vexing issues

The approval “is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain,” the regulator said.

Last week, an expert committee at the EMA recommended new manufacturing lines at a facility in Visp, Switzerland for the Moderna Inc. vaccine.

WATCH | Ottawa watching EU situation on vaccines carefully:

The federal government says it is ‘concerned,’ but does not expect Canada’s COVID-19 vaccine supply to be affected by a proposed export restriction by the European Union. It’s less clear if there’d be any impact from a temporary pause on exports of the AstraZeneca vaccine from the Serum Institute of India. 2:41

These changes are “intended to scale up production capacity and increase supply of the vaccine for the EU market,” the regulator said.

All COVID-19 vaccines meant for use in the EU must have their manufacturing sites approved by the EMA after a regulatory evaluation.

On Thursday, EU leaders failed to settle a fight about the distribution of COVID-19 shots among member states but pledged to strengthen vaccine export controls and production on EU soil amid a shortage of doses and spikes in new cases.

At the end of the summit, the bloc’s 27 nations were still locked in a dispute over how an upcoming batch of 10 million doses could be allocated to narrow the vaccine gap between member states, and the leaders decided to push the talks to a future meeting of their ambassadors.

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EU drug regulator backs AstraZeneca-Oxford COVID-19 vaccine after safety investigation

The EU’s drug watchdog said on Thursday it is still convinced the benefits of the AstraZeneca-Oxford COVID-19 vaccine outweigh the risks following an investigation into reports of blood clotting disorders that prompted more than a dozen nations to suspend its use.

The European Medicines Agency (EMA) director Emer Cooke said the watchdog could not definitively rule out a link between blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

But she said in a briefing that the “clear” conclusion of the review was that the vaccine’s benefits outweigh the possible risks.

“This is a safe and effective vaccine,” Cooke said.

‘I would be vaccinated tomorrow’

However, she said the agency will update its guidance for patients and health-care professionals to include an explanation about potential risks.

“If it were me, I would be vaccinated tomorrow,” Cooke said.

But the EMA wants “to raise awareness among people who have been vaccinated or are going to be vaccinated about things they should look out for,” she said.

The agency has been under growing pressure to clear up safety concerns after a small number of recent reports about bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering five million people included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

Cooke said the EMA is in touch with regulators around the world to keep tabs on possible side-effects of all COVID vaccines.

The EMA’s focus and primary concern has been on cases of blood clots in the brain, a rare, difficult to treat condition called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST). 

Countries suspended shots

More than 45 million doses of the AstraZeneca vaccine have been administered across the EEA.

At least 13 European countries, including France, Germany and Italy, have stopped administering the shot pending the review, the latest blow to the bloc’s faltering inoculation campaign.

The vaccination centre at the Erfurt, Germany exhibition centre was deserted on Tuesday. After the suspension of the AstraZeneca COVID-19 vaccine, thousands of appointments were cancelled. (Martin Schutt/dpa/The Associated Press)

Britain’s medicines regulator said on Thursday it was investigating five cases of CVST among people given AstraZeneca’s vaccine but it reaffirmed that the benefits of the shot far outweighed any possible risks.

The World Health Organization also this week reaffirmed its support for the shot.

AstraZeneca has said a review covering more than 17 million people who had received the shots in the EU and Britain had found no evidence of an increased risk of blood clots.

Many governments have said the decision to pause inoculations was made out of an abundance of caution, but experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants.

The bloc’s vaccine rollout has lagged behind campaigns by the United States and former EU member Britain.

WATCH | Inside the race to get COVID-19 vaccines to Canadians:

CBC’s David Cochrane goes inside the processes of vaccine delivery and distribution as well as the challenges to deliver on the promise of at least one shot for every Canadian who wants it by July 1. 4:08

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Regulator investigating 2 Ont. nurses who travelled to D.C. rally promoting ‘COVID fraud’ conspiracy

Ontario’s nursing regulator says it is investigating two nurses who travelled to Washington, D.C., last week to attend a rally by a group of their peers that has made unsubstantiated, conspiratorial claims about “COVID fraud” and hospitals’ alleged role in misrepresenting the coronavirus pandemic. 

Kristen Nagle, a neonatal ICU nurse from London, Ont., and Sarah Choujounian, a registered practical nurse from Toronto, travelled to the United States last week despite current public health directives to avoid all non-essential travel in order to help mitigate the spread of the novel coronavirus.

The College of Nurses of Ontario confirmed the two nurses, who have participated in events protesting COVID-19 public health measures in Canada, were already under investigation and said it is aware of their recent trip to D.C. to attend an event organized by Global Frontline Nurses (GFN).

The group’s members claim hospitals around the world are misreporting cases of the virus and needlessly placing patients on ventilators and diagnosing people with COVID-19 in order to make money off the crisis. 

“I can advise that CNO is investigating these members and that we are aware of the information indicated,” said spokesperson Angela Smith in response to CBC News questions about the investigation.

Smith said regulations prevent the college from providing details on the status of the investigation.

‘It’s shocking’

Doris Grinspun, CEO of the Registered Nurses’ Association of Ontario, calls the views promoted by Global Frontline Nurses “pure conspiracy theory.” 

“It’s damaging because what people need is factual information,” Grinspun, who has filed a complaint against Nagle with the college over her past activities, said in an interview. 

“When you hear this from one of your own, and in this case, two of our own, one RN and one RPN, it’s shocking.”

GFN’s members gathered on the steps of Capitol Hill in Washington, D.C., on Jan. 6 hours before thousands of supporters of U.S. President Donald Trump descended on the Capitol to try to stop the certification the presidential election results by violently overwhelming police and storming into the building.

According to a press release issued ahead of the GFN event, the intent was to “share insight about COVID fraud and corruption inside hospitals.”

Attended past anti-mask events

Nagle and Choujounian have attracted the attention of American media for attending the GFN event at a time when the U.S.-Canada border is supposed to be shut to all non-essential travel.

The two nurses are no strangers to public controversy. Both have participated in rallies against wearing masks and government-mandated lockdowns during the COVID-19 pandemic. 

Nagle, who works as a neonatal nurse at London Health Sciences Centre (LHSC), was one of the organizers of an anti-mask rally in Victoria Park in November that resulted in a number of charges being laid under the Reopening Ontario Act

Since that rally, Nagle has been placed under investigation by the college and her employer. A spokesperson for LHSC said she will remain on unpaid leave pending the results of the hospital network’s probe.

Erinor Jacob-Levine told CBC News in an email that LHSC is aware of Nagle’s trip south of the border. 

“We want to assure our community that we take this situation and the new events that have come to light very seriously,” Jacob-Levine said.

“While we are not able to address the specifics of an internal investigation due to privacy, safeguarding the health of our patients and their families, staff and physicians is of the utmost importance and remains our top priority.”

Nagle, left, and Choujounian, far right, seen with another member of Global Frontline Nurses in January 2021, have both participated in past events in Canada that have opposed COVID-19 public health measures such as mask wearing and lockdowns. (Sarah Choujounian/Instagram)

Toronto nurse says she was fired from nursing home

Choujounian currently works for S.R.T. MedStaff, according to the Ontario College of Nurses. The company describes itself as “a leading provider of nursing and personal support services to over 30 hospitals in the Greater Toronto Area.” 

Carolyn Acton, vice-president of patient services and operations at S.R.T. MedStaff, said in an email that the company could not discuss Choujounian’s travels because of privacy considerations.

However, she said policies are in place to prevent staff who have travelled outside the country from coming in contact with patients. 

“Currently, any staff who has travelled outside of Canada is required to self-isolate for 14 days and to contact Public Health,” Acton wrote. “At the end of the 14 day isolation period, we re-screen staff and also require that they are cleared by Public Health prior to being reinstated for work.”

A YouTube video shows Choujounian telling a crowd at an anti-lockdown rally in Toronto in November that she was fired from her job at Norfinch Care Community, a nursing home in the North York neighbourhood of Toronto, for “speaking the truth” and sharing her opinion about the pandemic online. 

Sienna Senior Living, the company that owns Norfinch Care Community, confirmed to CBC News on Monday that Choujounian is “no longer an employee” at the nursing home but wouldn’t provide further details, citing privacy reasons. 

Nurses facing ‘death threats and harassment’: GFN

Jeff Louderback, a spokesman for Global Frontline Nurses, confirmed the two Canadian nurses attended the Jan. 6 event but told CBC News via text message that Nagle and Choujounian were “not available for interviews” because they have been subject to “death threats and harassment.” 

CBC News attempted to contact Choujounian on social media and received no reply.

Attempts were also made to reach Nagle through her social media accounts and through her brother on social media but were unsuccessful.

The nurses documented their trip and the GFN event on social media.

A group of nurses, including two who are now under investigation by Ontario’s nursing regulator, gathered in Washington D.C. last week. Video captured from the Instagram account of Kristen Nagle of London, Ont. 1:58

They were seen together with other GFN members in one video posted on Nagle’s Instagram account last week. The video was made private following media reports about the trip but was seen by CBC News while it was still public. 

In the video, Nagle and Choujounian are seen with at least five other people, none of whom are wearing masks, inside what appears to be a hotel room.

They recount attending a Trump rally that was held last Wednesday south of the White House before some of the supporters moved to the Capitol.  

“I keep getting messages wondering if we’re OK. We are all safe,” Nagle says in the video before passing her phone to Choujounian, who talks about carrying a pro-Trump flag for fear of being mistaken for a supporter of the far-left group Antifa because she was dressed all in black.

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Chiropractors making misleading claims about pregnancy and birth targeted by B.C. regulator

B.C. chiropractors who make misleading claims about helping pregnant women give birth more comfortably or avoid postpartum depression have a little more than a month to scrub their websites.

The College of Chiropractors of B.C. said Monday it’s giving all practitioners until Jan. 30 to clean up their marketing to keep it in line with updated policies about pregnancy-related conditions and labour, or face investigation and possible discipline.

A public notice posted on the college website says it “has become concerned with statements made by some registrants which suggest that chiropractic care has the ability to turn a breech baby in utero and promote easier birth experiences. These claims are not well supported by evidence and are therefore misleading to the public.”

In a handful of websites reviewed by CBC, some chiropractors make claims about helping “decrease pain in pregnancy and labour” or providing treatment that “allows the baby to get in the best possible position in utero.”

Under the college’s revised efficacy claims policy, B.C. chiropractors will no longer be permitted to say:

  • They can help move a fetus out of the breech position.
  • They can give a fetus more room to develop in the uterus.
  • Chiropractic treatment during pregnancy will produce a healthier baby.
  • They can help pregnant women avoid birth by caesarean section or extraction using forceps or suction.
  • The chiropractic treatment can prevent a difficult labour or traumatic birth experience.
  • Birth is inherently traumatic to babies and/or requires chiropractic treatment to correct.
  • Chiropractic treatment can help regulate a woman’s hormones or reduce her risk of postpartum depression.

College trying to be ‘more proactive’

College registrar Michelle Da Roza told CBC the updated policy was not prompted by complaints from the public.

“The [college] is working to be a more proactive regulator and wanted to address its own concerns,” Da Roza said in an email.

The college’s notice specifically targets marketing of the Webster Technique, a treatment of the pelvis and lower spine that is often promoted to pregnant women as a method of ensuring a more comfortable birth.

The college says it has updated the chiropractors’ professional conduct handbook to make it clear the Webster Technique can only be advertised as “a specific chiropractic sacral analysis and diversified adjustment for all weight-bearing individuals.”

Last year, the college brought in a new policy that bars chiropractors from claiming to treat conditions like autism and cancer. (Konstantin Shadrin/Shutterstock)

The changes come a little more than a year after the college first introduced the efficacy claims policy, which set out a long list of conditions that chiropractors cannot claim to treat, including autism spectrum disorder, ADHD, infections, cancer and Alzheimer’s disease.

As part of the effort to crack down on those misleading claims, the college developed software that can scan chiropractors’ websites and social media for false advertising. A total of 65 B.C. chiropractors were found to be in violation of the policy after it was fully implemented in November 2018, according to the college’s annual report for 2018-19.

Da Roza said the college will use the same software to search for misleading claims about pregnancy and birth. Chiropractors have been told to look over all of their marketing materials to make sure they’re up to snuff before the Jan. 30 deadline.

Anyone who practises contrary to the rules will face an investigation, the college’s public notice says.

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World’s 1st Ebola vaccine gets green light from EU regulator

The European Medicines Agency has recommended that the world’s first Ebola vaccine be approved, after it was administered to hundreds of thousands of people in Africa.

The agency on Friday described licensing the vaccine as “an important step toward relieving the burden of this deadly disease.”

The Ebola vaccine was originally developed in Canada and is now marketed by Merck as Ervebo. More than 270,000 people in Africa have received it under emergency guidelines as officials try to stop Congo’s ongoing outbreak.

Merck said in a statement its priority now was to get regulatory approval of its Ervebo manufacturing site in Germany so that licensed supply of the vaccine “can be used to support global public health preparedness.”

A second vaccine made by Johnson & Johnson, which is not yet licensed, will soon be used in parts of Congo where Ebola is not actively spreading.

Also Friday, the World Health Organization is convening a meeting to consider whether the epidemic in Congo should still be designated a global emergency.

Ebola virus causes haemorrhagic fever and spreads from person to person through direct contact with body fluids.

There are currently no licensed treatments for the deadly infection, but scientists said in August they were a step closer to being able to cure it after two experimental drugs showed survival rates of as much as 90 per cent in a clinical trial in Congo. 

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Facebook recording of user audio prompts probe from EU privacy regulator

Facebook’s lead regulator in the European Union is seeking information over how it handled data during the manual transcription of users’ audio recordings, Ireland’s Data Protection Commision said on Wednesday.

Bloomberg reported on Tuesday that Facebook had been paying outside contractors to transcribe audio clips from users of its messenger service.

According to the report, the audio in question came from users who chose the option in Facebook Messenger to have their chats transcribed for them. The chats were transcribed by artificial intelligence and the contractors were brought in to check the accuracy, the report said.

Facebook, which has been facing broad criticism from lawmakers and regulators over its privacy practices, said in response to the Bloomberg story: “Much like Apple and Google, we paused human review of audio more than a week ago.”

Ireland’s Data Protection Commission (DPC), Facebook’s lead regulator in the European Union, already has eight individual probes into the U.S. social media giant, plus two into its WhatsApp subsidiary and one into Facebook-owned Instagram.

“Further to our ongoing engagement with Google, Apple and Microsoft in relation to the processing of personal data in the context of the manual transcription of audio recordings, we are now seeking detailed information from Facebook on the processing in question and how Facebook believes that such processing of data is compliant with their GDPR obligations,” the commission said in an emailed statement, referring to EU data privacy rules.

Bloomberg, citing the company, reported that the users who were affected chose the option in the Messenger app to have their voice chats transcribed. The contractors were checking whether Facebook’s artificial intelligence correctly interpreted the messages.

Under the EU’s General Data Protection Regulation (GDPR), regulators have the power to impose fines for violations of up to four per cent of a company’s global revenue or $ 22 million US, whichever is higher.

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DNA test to spot cancer genes gets OK from U.S. regulator, but with warnings

U.S. regulators have approved the first direct-to-consumer breast cancer gene test.

But the U.S. Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe.

The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations. It cannot determine a person’s overall risk of developing cancer.

The FDA says the test is not a substitute for regular medical checkups and should not be used to make any medical decisions. Most cancers are not caused by genetic mutations, and the ones tracked by the test aren’t the most common BRCA mutations.

Donald St. Pierre of the FDA’s Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that “it has a lot of caveats.”
Only a small percentage of Americans carry one of the three mutations, and most of the 1,000 known BRCA mutations that increase an individual’s cancer risk are not included in the test. The test should not be used as a substitute for regular cancer screenings, he said.
The FDA also cautioned against using the results to make treatment decisions, such as anti-hormone therapies or the surgical removal of the breast or ovaries. Those decisions should be based on confirmatory tests and genetic counselling.
And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor.
The regulator said it reviewed data for the company’s test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. The agency also outlined special controls designed to assure test’s accuracy and reliability.
To win approval, the company submitted data showing its instructions and reports are easy to understand. They provide information on what the results might mean and where to get additional information.

The FDA blocked 23andMe from offering genetic health information in 2013. The company has gradually won clearance to reintroduce some testing services.

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Herbal supplement kratom contains opioids, U.S. regulator says

Kratom powder

Kratom, a coffee-like plant native to southeast Asia which has similar properties to heroin and morphine is readily available in Canada. (Earth Kratom)

U.S. health authorities say an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids, the addictive family of drugs at the centre of a national addiction crisis.

The U.S. Food and Drug Administration analysis, published Tuesday, makes it more likely that the supplement, kratom, could be banned by the federal government.

The FDA also said it has identified 44 reports of death involving kratom since 2011, up from 36 reported in November.

Sold in various capsules and powders, kratom has gained popularity in the U.S. as a treatment for pain, anxiety and drug dependence. Proponents argue that the substance is safer than opioid painkillers like OxyContin and Vicodin, which have contributed to an epidemic of drug abuse. More than 63,000 Americans died in 2016 from drug overdoses, mostly from opioids.

‘Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous.’– FDA Commissioner Scott Gottlieb

FDA Commissioner Scott Gottlieb reiterated that there are no FDA-approved medical uses for kratom, which is derived from a plant native to Southeast Asia.

“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” Gottlieb said in a statement. “It’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally.”

FDA scientists analyzed the 25 most common chemical compounds in kratom and concluded that they behave like those found in opioids including morphine.


Kratom remains legal under federal law. But FDA inspectors have been seizing and destroying shipments at international mail facilities for months.

The FDA has submitted its review to the Drug Enforcement Administration, which is considering whether to place kratom in the same category of illegal drugs as heroin and LSD. The agency was poised to take that step in the summer of 2016, but delayed a decision after a flood of public complaints, including a letter signed by 62 members of Congress and a protest at the White House by kratom supporters.

There is no timeframe for the DEA’s final decision. 

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