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Government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters.

The US researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning.

Singulair was a blockbuster product for Merck after its launch in 1998, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so benign that they were “similar to a sugar pill,” while the label said any distribution in the brain was “minimal.” Generic versions are still prescribed to millions of adults and children every year.

But by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the US Food and Drug Administrations tracking system. Such “adverse event” reports do not prove a causal link between a medicine and a side effect, but are used by the FDA to determine whether more study of a drugs risks are warranted.

After years of analysis, the reports and new scientific research led the FDA in 2020 to add a “black box” warning to the montelukast prescribing label, flagging serious mental health risks like suicidal thinking or actions.

The agency also convened a group of internal experts around the same time to look into why the drug might trigger neuropsychiatric side effects.

The results of the group’s work, which are preliminary and have not been previously reported or released publicly, were presented to a limited audience at the American College of Toxicology meeting in Austin, Texas on Wednesday.

The FDA said it does not plan to update the drug label based on data from the presentation.

The behavior of montelukast appears similar to other drugs known to have neuropsychiatric effects, such as the antipsychotic risperidone, according to FDA slides reviewed by Reuters. The FDA has cautioned that its studies are ongoing, and results have not been finalized.

When the FDA added the black box, it cited research from Julia Marschallinger and Ludwig Aigner at Austria’s Institute of Molecular Regenerative Medicine.

The two scientists told Reuters on Thursday the new data showed significant quantities of montelukast present in the brain. The receptors involved play a role in governing mood, impulse control, cognition and sleep, among other functions, they said.

The research does not show whether that binding mechanism leads directly to harmful effects in individual patients, or who is particularly at risk, the two scientists said. However, Marschallinger said the new data bolsters reports from people who reported suffering side effects.

“It’s definitely doing something that’s concerning,” she said.

A Merck representative did not respond to questions. Organon, a Merck spinoff that now markets Singulair, said in a statement it is confident in the drug’s safety profile.

“The product label for Singulair contains appropriate information regarding Singulair benefits, risks and reported adverse reactions,” the company said.

Reuters reported last year that the FDA had received thousands of reports of patients, including many children, experiencing depression, suicidal thoughts and behaviors, or other psychiatric problems after they began using montelukast.

By 2019, the FDA tallied 82 suicides linked to Singulair and its generic versions reported to its adverse-event database since 1998. At least 31 of those reports involved someone 19 or younger.

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Robert England’s 22-year-old son Nick killed himself in 2017 less than two weeks after starting montelukast. England recalls that his son had trouble sleeping before he died, and said he was completely healthy and had no mental health problems prior to taking the drug.

“He was on that medication for just days, literally just days,” England said. “It completely changed the trajectory of our lives.”

The Reuters report also detailed lawsuits alleging that Merck knew from its early research that the drug could impact the brain and minimized the potential for psychiatric problems in statements to regulators. Many of those lawsuits are still pending.

If you are struggling with suicidal thoughts or are experiencing a mental health crisis and live in New York City, you can call 1-888-NYC-WELL for free and confidential crisis counseling. If you live outside the five boroughs, you can dial the 24/7 National Suicide Prevention hotline at 988 or go to SuicidePreventionLifeline.org.

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Oilers forward Hyman injured in 1st, exits Game 4

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Oilers forward Hyman injured in 1st, exits Game 4

EDMONTON, Alberta — Edmonton Oilers‘ top-line forward Zach Hyman was ruled out for the rest of Game 4 of the Western Conference finals Tuesday against the Dallas Stars after taking a hit from forward Mason Marchment, ESPN’s Emily Kaplan reported on the game broadcast.

The first-period collision appeared to immediately rattle Hyman, who dropped his stick and seemed to favor his right arm or wrist. Hyman went directly to the Oilers’ dressing room and did not return.

Hyman has been a key member of the Oilers’ postseason success, registering a league-leading 119 hits in 14 playoff games and scoring five goals and 11 points. He’s a fixture on the team’s top forward unit with Connor McDavid and is part of both the Oilers’ power play and penalty kill.

Edmonton was already down a forward going into Game 4 with Connor Brown sidelined after a hit from Dallas defenseman Alexander Petrovic in Sunday’s Game 3. Viktor Arvidsson returned to the lineup as Brown’s replacement on the fourth line.

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Referee Rooney returns, 11 days after high stick

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Referee Rooney returns, 11 days after high stick

EDMONTON, Alberta — NHL official Chris Rooney was back on the ice Tuesday night for Game 4 of the Western Conference finals between the Edmonton Oilers and Dallas Stars.

It was the veteran referee’s conference finals debut, and a fitting return for Rooney given the circumstances. It was Rooney’s first game since he took a high stick to the face on May 17 during Game 7 of the Eastern Conference second-round series between the Toronto Maple Leafs and Florida Panthers.

Rooney was injured 13 seconds into the second period when Panthers’ defenseman Niko Mikkola caught him with the end of his stick while fighting for a puck. Rooney fell to the ice and was tended to by trainers from both teams.

While bloodied, he was able to leave under his own power. Rooney sustained a black eye and received stitches for his injury but had no lasting damage. He was replaced at the time by Garrett Rank, in the building on standby in case on injury.

It was clear even the day after his injury that Rooney, 50, hoped to resume duties at some point in the playoffs. The Boston native was finally able to step in for Game 4 with fellow referee Dan O’Rourke.

The pair was joined by linesmen Ryan Gibbons and Matt MacPherson. Referee Graham Skilliter and linesman Ryan Daisy were in the building as alternates.

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Hintz (leg) back in action, joins Stars’ top line

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Hintz (leg) back in action, joins Stars' top line

EDMONTON, Alberta — Dallas Stars forward Roope Hintz is back in the lineup for Game 4 of the Western Conference finals Tuesday.

The club’s top skater, sidelined since Game 2, when he took a slash to the left leg from Edmonton Oilers defenseman Darnell Nurse, was placed on the top line, alongside Jason Robertson and Mikko Rantanen after taking warmups and line rushes prior to puck drop.

Hintz also took part in warmups before Game 3 on Sunday but exited early and was ruled out. He was back on the ice for Dallas’ optional practice Monday and told reporters he was “feeling good” and “trying to do everything I can” to get back in for Game 4.

It was early in the third period of Game 2 when Hintz — parked in front of the Oilers’ net — shoved Nurse from behind, and the Oilers’ blueliner responded by swinging his stick at Hintz’s leg. Hintz went down to the ice for several minutes before being helped off by Lian Bichsel and Mikael Granlund.

Nurse received a two-minute penalty for the slash but no supplementary discipline from the league. The blueliner addressed the incident publicly for the first time Tuesday, saying it didn’t come with malicious intent.

“I was backing up to net and I got shot in the back. And I think it was just a natural reaction [to respond],” Nurse said. “It’s probably a play that everyone in this room, whether you’re a net-front guy or D man, probably happens a dozen, two dozen times in a year. It’s unfortunate that I must have got [Hintz] in a bad spot. You don’t want to go out there and hurt anyone. But it was just one of those plays that happens so often.”

Having Hintz unavailable hurt the Stars in Game 3, a 6-1 drubbing by the Oilers that put Dallas in a 2-1 hole in the best-of-seven series. Hintz is the Stars’ second-leading scorer in the postseason, with 11 goals and 15 points through 15 games. He was hopeful when taking warmups Sunday that he’d feel good enough to get back in, but a quick discussion with the training staff made it clear he wasn’t ready.

Before Tuesday night, coach Peter DeBoer had since classified Hintz’s status as day-to-day.

“Of course you want to go every night, but sometimes you just can’t,” Hintz said. “I don’t know how close I [was to playing]. But I have played many years [and I] know when it’s good and when it’s not. I should be good to know that [when] it comes to that decision.”

The Oilers will have some lineup changes of their own to sort through in Game 4. Connor Brown, who is out after taking a hit from Alexander Petrovic in Game 3, will be replaced by Viktor Arvidsson. Calvin Pickard, injured in Edmonton’s second-round series against Vegas, will return to back up Stuart Skinner. And Edmonton continues to wait on defenseman Mattias Ekholm, who is getting closer to returning from a lower-body injury.

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