Phenylephrine, a in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration agreed Tuesday.
Phenylephrine is the main ingredient used in products like Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex.
The ingredient is considered safe to use; that was not up for debate. But many doctors have questioned phenylephrine’s effectiveness for years. These products generated nearly US$1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee on Monday during the committee’s two-day meeting.
On Tuesday, the committee voted no on the specific question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant.â€
The vote was unanimous among its 16 members, and the committee agreed that the issue doesn’t need to be studied any further.
“We really should not have products on the market that are not effective,†said committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy.
The FDA told the committee it would take its advice into consideration, although it did not give a timeline. If the agency decides to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE), stakeholders would have the opportunity to comment on the proposed change and to provide any additional data. During that process, companies would still be allowed to market products with phenylephrine. But if the FDA agrees with the committee, companies may be required to remove products with phenylephrine from store shelves or reformulate them.
The agency approved phenylephrine for over-the-counter use in the 1970s, but it became even more common after 2005, when legislation restricted access to OTC drugs that use a similar decongestant ingredient called pseudoephedrine.
In 2007, the FDA committee looked at the science available at that time and came to a different conclusion, agreeing that the phenylephrine “may be effective,†but it also called for more research.
Studies since then, including three large clinical trials, showed that the orally administered ingredient is not effective as a decongestant in its typical dosage.
The committee also looked at other research used to support its use over-the-counter. The FDA found that those study results were inconsistent and many did not meet modern scientific standards.
The committee did not take up the issue of nasal spray products that use phenylephrine, which studies seem to show are effective, at least temporarily.
Phenylephrine is considered the most common ingredient in over-the-counter oral nasal and sinus products, according to the American Academy of Allergy, Asthma and Immunology. a citizens petition to remove the drug’s over-the-counter status.
Phenylephrine works by temporarily reducing the swelling of blood vessels in the nasal passages. A respiratory infection or allergies prompt the body to send white blood cells to the nose, throat and sinuses, leading to swelling in the nasal membranes and the creation of mucus. Decongestants constrict the blood vessels in the sinuses and nose, reducing the swelling and helping fluids drain.
In pill form, some scientists say, phenylephrine gets absorbed by the gut and is metabolized so well that only a tiny bit makes it to the bloodstream, where it is needed to reach the nose, according to the that asks the FDA to pull the drug from store shelves. A is a way for industry, consumer groups or individuals to petition the FDA to change regulations or take other administrative action.
In discussing Tuesday’s vote, the committee agreed that safety wasn’t why they wanted the FDA to take action on these products. Rather, they were advising the FDA to act because the tablets were essentially a waste of money, and over-the-counter medications can help people who have colds or allergies.
“It’s amazing the amount of dollars being spent on something that has really no efficacy,†said committee member Dr. William Fig, a clinical pharmacologist and investigator at the National Cancer Institute.
Every year, many Americans seek relief with over-the-counter cold and allergy medicine. About 60 million people in the United States have allergies, and adults get two to four colds per year, according to the , for a total of 1 billion colds a year.
Colds and allergies can have a significant effect on quality of life, . In addition to a runny nose and coughs, allergies and colds can aggravate asthma and cause trouble sleeping.
A change to phenylephrine’s designation could be costly to manufacturers. The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines and dietary supplements as well as consumer medical devices, opposes a change.
The Tuesday that it was disappointed in the committee’s decision and encouraged the FDA, before it makes any regulatory changes, to “be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status.â€
It told the FDA committee that its surveys show that people prefer their decongestants in tablet form over nasal spray. If these drugs were not available anymore, it could be a real burden to consumers, the association said.
On Tuesday, the FDA committee said that if the FDA decides to reclassify phenylephrine and it goes off the market, the agency will need to educate the public about why some of popular allergy and cold drugs were no longer available.
If phenylephrine is no longer available, there are several other OTC options including nasal spray antihistamines, nasal corticosteroids and nasal saline products, as well as tablets with pseudoephedrine.
Products with pseudoephedrine are considered OTC but are kept behind the counter because in large quantities, pseudoephedrine can be used to make the illegal drug methamphetamine.
CNN’s Meg Tirrell contributed to this report.
It's been exactly three years since Canadian Michael Kovrig returned to Canada after spending 1,019 days in a Chinese prison. Now, he's publicly speaking out about his arrest and detainment for the first time.
Cineplex Inc. has been ordered to pay a record $38.9 million fine after the Competition Tribunal found the theatre owner guilty of deceptive marketing practices.
While many Canadians no longer stress as much about COVID-19 as they did during its peak, health experts say a new variant has been spreading in some parts of the world and is now present in Canada.
Police say a toddler in Cambridge, Ont., who was reported missing early Monday morning, has since died.
Israeli strikes on Lebanon Monday killed more than 490 people, including more than 90 women and children, Lebanese authorities said, in the deadliest barrage since the 2006 Israel-Hezbollah war.
On Sept. 20, Justice R.E. Nation of the Alberta Court of King's Bench found Craig McMorran guilty of fraud, money laundering and stealing a cottage from its rightful owners.
B.C.’s Civil Resolution Tribunal has ordered WestJet to refund a family in full for their diverted flight and compensate them for associated costs.
The City of Montreal has issued a lockdown notice for residents in the Mercier-Hochelaga-Maisonneuve borough due to smoke from a fire in a container storing 15,000 kilograms of lithium batteries in the Port of Montreal.
A new analysis of dozens of arrowheads is helping researchers piece together a clearer portrait of the warriors who clashed on Europe’s oldest known battlefield 3,250 years ago.
On Sept. 20, Justice R.E. Nation of the Alberta Court of King's Bench found Craig McMorran guilty of fraud, money laundering and stealing a cottage from its rightful owners.
It's been exactly three years since Canadian Michael Kovrig returned to Canada after spending 1,019 days in a Chinese prison. Now, he's publicly speaking out about his arrest and detainment for the first time.
Ontario's police watchdog is investigating after a Durham officer discharged a Taser and an anti-riot weapon at a 15-year-old boy in north Oshawa on Sunday.
The City of Montreal has issued a lockdown notice for residents in the Mercier-Hochelaga-Maisonneuve borough due to smoke from a fire in a container storing 15,000 kilograms of lithium batteries in the Port of Montreal.
Authorities are investigating a report that violence erupted on a pickleball court in B.C.'s Lower Mainland over the weekend.
Police say a toddler in Cambridge, Ont., who was reported missing early Monday morning, has since died.
Malaysian police said Monday they have rescued 187 more children and raided locations nationwide linked to an Islamic business group that is being investigated for alleged sexual assault of children.
Israeli strikes on Lebanon Monday killed more than 490 people, including more than 90 women and children, Lebanese authorities said, in the deadliest barrage since the 2006 Israel-Hezbollah war.
Japan’s meteorological agency on Tuesday issued a tsunami advisory to a group of remote islands south of Tokyo after a strong earthquake.
A mentally ill man who killed 10 people at a Colorado supermarket in 2021 was convicted Monday of murder and faces life in prison.
A Soyuz capsule carrying two Russians and one American from the International Space Station landed Monday in Kazakhstan, ending a record-breaking stay for the Russian pair.
The man accused in the apparent assassination attempt of Donald Trump at a golf course in Florida left behind a note saying that he intended to kill the former president and maintained in his car a handwritten list of dates and venues where Trump was to appear, the U.S. Justice Department said Monday.
Following another byelection loss in a riding long considered a Liberal stronghold, coupled with the news another minister is quitting cabinet — and opting to sit as an independent MP — the weekly panel of political strategists on CTV's Question Period weighs in on the Liberals' political fortunes.
Justin Trudeau will turn his focus to the ongoing crises in Haiti as he speaks with some world leaders Monday ahead of the 78th meeting of the United Nations General Assembly.
House of Commons Speaker Greg Fergus gave MPs a stern warning on Monday about improving their behaviour as they prepare for a fractious debate about whether the Liberals should continue to govern.
Private nursing agencies could cost Canadian health-care facilities approximately $1.5 billion in 2023-24, according to a new report commissioned by the Canadian Federation of Nurses Unions.
While many Canadians no longer stress as much about COVID-19 as they did during its peak, health experts say a new variant has been spreading in some parts of the world and is now present in Canada.
There are 'no restrictions' on the right to receive health services in Quebec for English speakers, according to a new clarification document issued by the Quebec Health Ministry on Monday.
A new analysis of dozens of arrowheads is helping researchers piece together a clearer portrait of the warriors who clashed on Europe’s oldest known battlefield 3,250 years ago.
Finally, an emoji to represent us all is coming soon: An exhausted face with bags under its eyes.
A Soyuz capsule carrying two Russians and one American from the International Space Station landed Monday in Kazakhstan, ending a record-breaking stay for the Russian pair.
Beverly Glenn-Copeland says he's been diagnosed with dementia and will play his final concert tour dates over the next two weeks.
The sexual assault trial for Canadian musician Jacob Hoggard, the former frontman for the band Hedley, is expected to begin in northern Ontario this week, following a jury selection process.
The Juno Awards are casting a spotlight on Canadian-made South Asian music as part of broader changes to the annual celebration.
Cineplex Inc. has been ordered to pay a record $38.9 million fine after the Competition Tribunal found the theatre owner guilty of deceptive marketing practices.
B.C.’s Civil Resolution Tribunal has ordered WestJet to refund a family in full for their diverted flight and compensate them for associated costs.
Canadian natural gas prices slumped to their lowest level in more than two years on Monday and are expected to remain under pressure for weeks.
The City of Ottawa says it is recruiting a 'nightlife council' to aid the city's recently appointed nightlife commissioner.
One simple action involving your smartphone could help improve your mental health at work, according to a new study.
Alcohol-free beer has been gaining popularity in recent years as beer consumption shrinks.
Surfer Mickey Brennan says he's 'amazed' to be alive after wiping out in a giant wave off Tasmania.
The Toronto Raptors are planning to retire Vince Carter's jersey next month, sources tell TSN.
The Philadelphia Flyers had a former hockey coach help him Monday at training camp — the father of the late John and Matthew Gaudreau, who was an invited guest.
Struggling Jeep and Ram maker Stellantis is looking for a CEO to succeed Carlos Tavares, but the company says it's just part of a normal leadership succession plan.
The U.S. Commerce Department on Monday will propose a ban on the sale or import of smart vehicles that use specific Chinese or Russian technology because of national security concerns, according to U.S. officials.
Northvolt plans to cut 1,600 jobs at its base in Sweden, or about a fifth of its global workforce, as Europe's biggest hope in the electric vehicle battery market struggles with production problems, sluggish demand and competition from China.
Giant gourds took over a Manitoba community this weekend.
Fire has destroyed a barn and 17,000 plants at a family-owned business in Lower Coverdale, N.B.
Before influencers on social media, Canada’s Jeanne Beker was bringing the world of high fashion down to earth and as Calgary’s Glenbow Museum gets a major make-over, it will include a new exhibition showcasing the pop culture icon.
A sea lion swam free after a rescue team disentangled it near Vancouver Island earlier this week.
A Nova Scotian YouTuber has launched a mini-truck bookmobile.
Cole Haas is more than just an avid fan of the F.W. Johnson Wildcats football team. He's a fixture on the sidelines, a source of encouragement, and a beloved member of the team.
Getting a photograph of a rainbow? Common. Getting a photo of a lightning strike? Rare. Getting a photo of both at the same time? Extremely rare, but it happened to a Manitoba photographer this week.
An anonymous business owner paid off the mortgage for a New Brunswick not-for-profit.
They say a dog is a man’s best friend. In the case of Darren Cropper, from Bonfield, Ont., his three-year-old Siberian husky and golden retriever mix named Bear literally saved his life.
A man accused of driving his truck into a march for B.C. residential school survivors two years ago has been found guilty of dangerous driving.
BC Conservative leader John Rustad dropped a major policy plan Sunday, pledging to eliminate supervised drug consumption sites across B.C. and replace them with intake centres for treatment and recovery.
B.C.’s Civil Resolution Tribunal has ordered WestJet to refund a family in full for their diverted flight and compensate them for associated costs.
A pedestrian has died and another is injured following a two-vehicle collision in Toronto's west end, paramedics say.
Ontario Premier Doug Ford says the Toronto District School Board (TDSB) should investigate how some students on a recent school field trip ended up at a rally where pro-Palestinian slogans were shouted.
A Toronto rapper who was charged in a fatal 2021 shooting has been released after a judge dismissed social media evidence in the case.
After four months of water conservation measures, the City of Calgary has lifted all restrictions.
Calgary police have released a photo of a suspect wanted in connection with a fire in the community of Riverbend that damaged multiple homes.
The City of Calgary has opened applications to design its permanent residential school memorial and the winning plan will be chosen in mid-2025.
There has been an apparent spike in the number of reported violent crimes in Ottawa this month. Police Chief Eric Stubbs says it's a concern.
The Canada Revenue Agency has provided new data on the number of employees who were found to have received the Canada Emergency Response Benefit during the COVID-19 pandemic.
The City of Ottawa says it is recruiting a 'nightlife council' to aid the city's recently appointed nightlife commissioner.
The City of Montreal has issued a lockdown notice for residents in the Mercier-Hochelaga-Maisonneuve borough due to smoke from a fire in a container storing 15,000 kilograms of lithium batteries in the Port of Montreal.
There are 'no restrictions' on the right to receive health services in Quebec for English speakers, according to a new clarification document issued by the Quebec Health Ministry on Monday.
The family of a Quebec man killed by Montreal police in 2017 is calling on the province's justice minister to order an independent investigation after the Crown declined to charge the officers involved.
A man driving a motorcycle is dead after an afternoon collision on Edmonton's Groat Road on Monday.
Matt Coronato scored twice and Jonathan Huberdeau assisted on three goals as the Calgary Flames beat the host Edmonton Oilers 6-3 in one of two split-squad games between the provincial rivals on Monday night.
The Alberta Medical Association (AMA) is urging the provincial government to implement a new compensation model for doctors and adopt a plan to stabilize acute care.
Construction on Almon Street in Halifax that started more than a month ago will continue longer than expected after city crews uncovered old tram lines beneath the road.
A series of high-value thefts have police warning Maritime business owners to be on the lookout.
Public health officials in Prince Edward Island are investigating an outbreak of gastrointestinal illness reported among 50 people who attended a shellfish festival over the weekend.
It was a tragic ending to the search for a six-year-old boy in northeastern Manitoba who had been missing since Wednesday.
A 20-year-old man has been charged in connection with the death of a 52-year-old woman in an Assiniboine Avenue apartment on Sunday.
The mayor of Lynn Lake, Man. is concerned about a bridge connecting to his community and what would happen if it became impassable.
The Saskatchewan Government is fighting to have a Court of King's Bench decision reversed. A decision which would allow a constitutional challenge of its Parents' Bill of Rights.
Farmer are thinking about more than their crops this harvest. They're talking about the upcoming Saskatchewan election and how provincial and federal policies may impact their economic future.
Emergency Crews including Regina Fire were called to a house fire in the community of Grand Coulee on Monday afternoon.
Three people were killed Monday morning in a crash north of Wellesley.
Police say a toddler in Cambridge, Ont., who was reported missing early Monday morning, has since died.
Residents at a Kitchener townhouse complex still haven’t been able to return to their homes, even though it's been 11 months since a fire at a neighbouring unit.
The Saskatchewan Government is fighting to have a Court of King's Bench decision reversed. A decision which would allow a constitutional challenge of its Parents' Bill of Rights.
Fire crews are battling a blaze at the Candle Lake Golf Course clubhouse on Monday morning.
The Saskatchewan Ministry of Education says a woman facing an assault charge is no longer working at a private Christian school where the alleged incident took place.
A family dispute related to a property matter turned ugly over the weekend when a 71-year-old hit their head on the pavement after being pushed.
Officials in the City of Timmins say the state of Municipal Road, which connects Timmins and Iroquois Falls, is well beyond the patch-up phase.
Sara Cunningham, the first woman to lead the Greater Sudbury Police Service, has been a police officer since she was 21.
While the employees will be the biggest beneficiaries, small businesses in Ingersoll are also banking on seeing benefits from a new contract for workers at CAMI.
519 Meets organized a car rally in south London on Saturday in a Value Village parking lot, and it turned out to be their largest ever.
In early August, Gord Leaman proudly put up a billboard on his front lawn that says 'Screw Trudeau, Screw Singh, Capitalism not Socialism, and White Lives Matter.'
Casino Rama announced three new performances will hit the stage this winter.
Some changes could be coming to one of the busiest streets in Simcoe County.
A Brampton man faces charges after police say a dispute over an unpaid bill at Blue Mountain Resort turned into a confrontation.
The Windsor Spitfires are set to get back on the ice for the 2024/2025 season, but not before warning fans of scam artists looking to pull a fast one.
Following the discovery of a potential petroleum well found in downtown Wheatley, the Municipality of Chatham-Kent is holding a community open house on Tuesday afternoon.
On Monday, most Windsor city councillors voted against a motion to cancel the development at 3930 and 3950 Sixth Concession Road, allowing the 24-unit townhouse project to proceed.
B.C.’s Civil Resolution Tribunal has ordered WestJet to refund a family in full for their diverted flight and compensate them for associated costs.
BC Conservative leader John Rustad dropped a major policy plan Sunday, pledging to eliminate supervised drug consumption sites across B.C. and replace them with intake centres for treatment and recovery.
Mounties are asking witnesses to come forward after a woman was struck by a vehicle and seriously injured in a crosswalk in Nanaimo, B.C.
A pair of runaway pigs are in the custody of an animal sanctuary in the Okanagan after evading police and volunteers for hours earlier this week.
The Red Bridge, a historic landmark in Kamloops, B.C., was completely destroyed by fire early Thursday morning.
Animal protection officers in British Columbia have rescued three pit bulls – including one that gave birth to 10 puppies – from a rat-infested home in Kelowna.
Farmers in southern Alberta are working to wrap up harvest, with 80 per cent of major crops in the bin, according to the province's latest crop report.
Monday marked the official start of Reconciliation Week in Lethbridge.
A Medicine Hat man faces charges after police say they found him in possession of drugs and a .22-calibre pen gun.
After playing the lottery for more than 40 years, a Greater Sudbury woman made a huge windfall playing a scratch ticket game.
A family dispute related to a property matter turned ugly over the weekend when a 71-year-old hit their head on the pavement after being pushed.
Police in Sault Ste. Marie charged a 36-year-old suspect with drug trafficking and other charges following a weekend raid of a residence on Robin Street.
Newfoundland and Labrador sponsored a minor football team in England, now they’re about to play one of the biggest clubs in European soccer.
Newfoundland and Labrador's chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.
A 16-year-old biennial event aimed at fostering business in the country's eastern Arctic and northern regions has been cancelled indefinitely as a dispute unfolds between Inuit in Canada and a Labrador group claiming to share their heritage.
The Shopping Trends team is independent of the journalists at Â鶹´«Ã½. We may earn a commission when you use our links to shop. Read about us.
