Common Muscle Relaxant Could Pose Mental Dangers for Seniors

Dennis Thompson wrote . . . . . . . . .

A commonly prescribed muscle relaxant known as baclofen can leave older kidney patients so disoriented that they land in the hospital, a new study warns.

“It can present with acute stroke-like symptoms, even though it’s not a stroke,” said senior researcher Dr. Amit Garg, a professor of nephrology at Western University in Ontario, Canada. “It can present with dementia-like symptoms.”

About 1 in 25 people with low kidney function prescribed high doses of baclofen wound up being admitted to a hospital for severe confusion, according to a study of nearly 16,000 older Canadians with chronic kidney disease.

By comparison, only one in 500 kidney patients not prescribed baclofen wound up hospitalized for confusion.

“There was a pretty marked difference in risk,” Garg said, noting that these findings “highlight a potential risk associated with these drugs that hasn’t been fully appreciated.”

Other seniors might also face this risk, since kidney function often declines as people grow older, he added.

Baclofen is typically prescribed to people suffering muscle spasms, Garg said. Doctors hand out more than 8 million prescriptions of baclofen every year. It’s sold under a number of different brand names, including Lioresal, Gablofen and Kemstro.

The drug leaves the body when the kidneys filter it out of a person’s blood, Garg explained.

“If someone’s kidney function isn’t working very well, that means the drug is accumulating in the system,” he said.

Garg and other doctors had started noticing that kidney patients on baclofen sometimes became disoriented and dazed.

For example, nephrologist Dr. Holly Koncicki remembers some dialysis patients showing up with noticeably clouded mental capacity.

“Of those I can remember, they often presented with confusion or being very sleepy and lethargic,” said Koncicki, of the Icahn School of Medicine at Mount Sinai, in New York City.

In the Canadian study, Garg and his colleagues combed the medical literature and found 30 prior case reports linking baclofen to hitches in brain function, so they decided to more closely study this potential problem.

The researchers pulled health data on nearly 16,000 older Ontario residents with chronic kidney disease who had been prescribed baclofen between 2007 and 2018.

The investigators compared those patients’ hospitalizations for mental conditions against those from a group of almost 300,000 kidney patients who’d not been prescribed the drug.

Patients were at greatest risk of hospitalization for confusion if their kidney function was very impaired — 30% or less — and they had been prescribed a high dose of baclofen, more than 20 milligrams (mg) per day.

But even patients with kidney function as high as 60% had an increased risk of confusion when prescribed high doses of baclofen, the findings showed. About 1 in 5 older adults live with kidney function of less than 60%.

Kidney patients prescribed baclofen at 20 mg/day or higher had nearly 20 times the relative risk of being hospitalized for an altered mental state, compared with patients not taking the drug, the researchers found.

Doses lower than 20 mg/day were associated with a nearly sixfold increase in kidney patients’ risk of hospitalization.

The results were published online in the Journal of the American Medical Association, to coincide with a planned presentation at the American Society of Nephrology annual meeting, in Washington, D.C.

Koncicki, who was not involved with the study, said, “In our older patients with impaired kidney function, there should be cautious use of this medication.”

Garg added that the effect might be even more widespread than what was found in the study, which only considered people so severely affected that they landed in the hospital.

He said he’s concerned that many more people “might have more subtle changes in their thinking who we aren’t even picking up in this study.”

People already taking baclofen should keep taking the drug but ask their doctor about these possible mental side effects, Koncicki and Garg said.

Patients “should feel empowered to ask questions about the risks and benefits of medications,” Koncicki said, “and side effects to watch out for so they can make an informed decision about whether a medication is right for them.”

Dr. Teresa Murray Amato, director of geriatric emergency medicine at Northwell Health in New Hyde Park, N.Y., agreed.

“All patients should speak to their doctors regarding side effects of all medications,” Murray Amato said. “For patients over 65, make sure you understand your kidney function and ask about potential renal dosing on all medications. If you are on baclofen now, make sure you contact your health care provider so that you can have an expedited conversation.”

“Please seek emergency care if you or your family member is showing any signs of altered [mental activity] and you suspect medications may be involved,” Murray Amato said.

Regulatory agencies also might consider strengthening the drug warning for baclofen to include this potential effect, Garg said.

Source: HealthDay

China Gives Conditional OK to Its First Self-developed Alzheimer’s Drug

China has granted conditional approval to its first self-developed treatment for Alzheimer’s disease, a move that may point to revived opportunities in a therapeutic area where drugmakers have burned billions of dollars without yielding a validated new drug.

Oligomannate, which uses extract from marine brown algae as raw material, received a conditional green light to treat mild-to-moderate level AD, the National Medical Products Administration (NMPA) said in a statement on its website late on Saturday.

An effective treatment for Alzheimer’s, which is estimated in 60%-70% of around 50 million dementia cases worldwide, could become one of the best-selling drugs globally.

“Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit,” Shanghai Green Valley Pharmaceuticals, which developed the drug along with two academic institutions in China, said in a statement.

The outlook for a cure is clouded with theoretical uncertainties and high-profile failures. Pharmaceutical giants including Johnson & Johnson, Merck and Pfizer have ditched their projects on unsatisfactory data.

Biogen last month revived its plans to seek U.S. approval for its aducanumab treatment after announcing in March that it would terminate two large clinical trials for the drug. But some analysts believed FDA approval is highly unlikely.

China is fast-tracking approval for innovative drugs at home in a bid to offer more and cheaper options to patients, as many in the rapidly aging country struggle to find alternatives to costly treatments sold by multinational pharmaceutical firms for chronic diseases.

In an August overhaul to its drug administration law, Beijing said conditional approval could be granted to some still-under-research medicines of “predictable” clinical value for life-threatening diseases for which effective treatment is not immediately available.

Further research on Oligomannate’s pharmacological mechanism and long-term safety and effectiveness is required, according to the NMPA statement.

Green Valley said it would launch the drug “very soon” in China. The company also aims to roll out a phase-3 clinical trial with sites in the United States, Europe and Asia in early 2020 to facilitate global regulatory approval of the drug.

Source : Reuters


Read also at BBC:

First drug that can slow Alzheimer’s dementia . . . . .

UPS Drone Makes First Home Prescription Deliveries for CVS

Lisa Baertlein wrote . . . . . . . . .

United Parcel Service Inc Flight Forward drones have flown prescription medications to the front lawn of a private home and to a retirement center, the UPS unit’s first revenue-generating deliveries for drugstore chain CVS Health Corp.

Flight Forward’s maiden delivery flight on Friday in Cary, North Carolina, beat rivals in one phase of the race for the nascent market. The second drone flight delivered medications to a public space at a retirement community.

The packages, roughly the size of small shoeboxes, were lowered from drones hovering at an altitude of about 20 feet.

UPS and CVS said on Tuesday the deliveries were the first of their kind under an program approved by the U.S. Federal Aviation Administration (FAA). Regulators are still hammering out rules for how the unmanned winged vehicles will operate in U.S. airspace and guidelines are expected in 2021.

“We see big potential in drone delivery in rural communities where life-saving medications are needed and consumers at times cannot conveniently access one of our stores,” said Kevin Hourican, president of CVS Pharmacy.

“CVS is exploring many types of delivery options for urban, suburban and rural markets,” Hourican added.

In September, UPS became the first company to win the broadest FAA certification to operate a drone airline. That permits Flight Forward to collect payment for drone deliveries and to fly as many drones supported by as many operators as necessary to meet customer demand.

Flight Forward and drone startup Matternet have inked a variety of deals to deliver biological samples on a handful of medical campuses.

Wing, a drone operator owned by Google parent Alphabet Inc, is partnering with Walgreens and FedEx Corp for a home delivery pilot in Christiansburg, Virginia.

Source: Reuters

People Taking Blood Thinners May Risk Danger by Mixing with Over-the-counter Medicines

People taking blood-thinning medications often use over-the-counter (OTC) medicines with the potential to cause dangerous internal bleeding, a recent study suggests.

The study focused on 791 patients prescribed apixaban, one of several newer blood thinners known as NOACs (non-vitamin K antagonist oral anticoagulants) that are recommended to prevent stroke in people with atrial fibrillation, a heart rhythm disorder.

Almost all of these patients used over-the-counter medicines, and 33% of them took at least one nonprescription drug daily or most days of the week with the potential to cause dangerous side effects when combined with apixaban. And almost 7% of them regularly took two or more over-the-counter medicines that could be a dangerous mix with apixaban.

“New OTC products are constantly being adopted by patients,” Dr. Derjung Tarn of the David Geffen School of Medicine at UCLA and colleagues write in the Journal of the American Geriatrics Society. “This study demonstrates that patients have limited knowledge about potential serious interactions between OTC products and apixaban.”

In atrial fibrillation, electrical impulses in the upper chambers of the heart are chaotic, causing the heart muscle to quiver rather than contracting normally. As a result, blood doesn’t flow smoothly through the heart. This can lead to the formation of clots that can then travel through the arteries to the brain.

NOACs are the drug of choice for stroke prevention in patients with atrial fibrillation, which occurs most frequently in older patients. Apixaban is one of the most frequently prescribed. Others include dabigatran, rivaroxaban, and edoxaban.

Unlike the older blood-thinner warfarin, which required regular blood tests to prevent side effects, most people prescribed apixaban or other NOACs are not followed in specialized anticoagulation clinics or monthly by health care professionals, the study team writes. As a result, they may not be aware of potential drug interactions.

In the current study, researchers surveyed patients prescribed apixaban in 2018. They asked patients how often they took over-the-counter remedies like aspirin, ibuprofen, naproxen, and acetaminophen. They also asked about common dietary supplements, including Chinese herbs, various fish oils, ginger and herbal teas.

Aspirin was the most commonly used nonprescription treatment in the study, and almost two-thirds of people on aspirin also took at least one other over-the-counter medicine with the potential to increase the risk of bleeding when mixed with apixaban.

The study didn’t look at whether mixing over-the-counter medicines or supplements with blood thinners actually caused bleeding or other dangerous side effects in these patients.

One limitation of the analysis is that researchers relied on patients to accurately recall and report on what over-the-counter medicines and supplements they used.

It’s also not clear from the study whether people started using any of these nonprescription remedies before or after they were prescribed apixaban.

“Patients who have taken OTC medications or dietary supplements without any problems prior to starting apixaban may not consider potential interactions, particularly if they ingest the supplements as part of their diet,” the study team writes.

“For example, certain ethnic groups may regularly incorporate dietary supplements, such as turmeric and Chinese herbs, in their meals,” the study team notes. “Unless providers ask them, patients may not realize these are important to disclose.”

Source: Reuters


Today’s Comic

Many Common Medicines Could Alter Your Microbiome

Some widely used drugs alter the population of microbes in the gut, and a number raise the risk of antibiotic resistance, a new Dutch study shows.

The gut microbiome includes at least 1,000 species of bacteria and is influenced by a number of different factors, including medication. Research suggests that changes in the gut microbiome are associated with obesity, diabetes, liver diseases, cancer and neurodegenerative diseases.

“We already know that the efficiency and the toxicity of certain drugs are influenced by the bacterial composition of the gastrointestinal tract and that the gut microbiota has been related to multiple health conditions; therefore, it is crucial to understand which are the consequences of medication use in the gut microbiome,” said lead researcher Arnau Vich Vila, from the University Medical Center Groningen.

In this study, the researchers examined 41 commonly used drug categories and assessed 1,883 fecal samples from people who did and didn’t take the drugs, including some with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

Eighteen of the drug categories had major effects on the gut microbiome, and eight increased the risk of antimicrobial resistance.

The categories with the biggest impact on the microbiome were:

  • Proton pump inhibitors (PPIs), used to treat indigestion, peptic ulcer, H. pylori eradication, gastro reflux and Barrett’s esophagus.
  • Metformin, used to treat type 2 diabetes.
  • Antibiotics, used to treat bacterial infections.
  • Laxatives, used to treat and prevent constipation.

The gut microbiomes of PPI users had higher levels of upper gastrointestinal tract bacteria and increased fatty acid production, and metformin users had higher levels of potentially harmful E. coli bacteria.

Seven other drug categories were associated with significant changes in bacterial populations in the gut, according to the researchers.

For example, the use of SSRI antidepressants by people with IBS was associated with increased levels of the potentially harmful bacteria species Eubacterium ramulus.

Meanwhile, the use of oral steroids was associated with high levels of methanogenic bacteria linked with obesity and an increase in body mass index (an estimate of body fat based on weight and height).

The study was to be presented Wednesday at the UEG (United European Gastroenterology) annual meeting, in Barcelona. Such research is considered preliminary until published in a peer-reviewed journal.

“Our work highlights the importance of considering the role of the gut microbiota when designing treatments and also points to new hypotheses that could explain certain side-effects associated with medication use,” Vila said in a meeting news release.

Source: Healthday