By The Defender Staff

Children’s Ibuprofen Recalled Nationwide Due to ‘Foreign Substance’

Newsweek reported:

U.S. health officials are urging parents and caregivers to check medicine cabinets after a nationwide recall was issued for 4‑fluid‑ounce bottles of Children’s Ibuprofen Oral Suspension, USP, a liquid product labeled 100 milligrams per 5 milliliters. The Food and Drug Administration (FDA) said the recall follows consumer complaints describing the presence of a foreign substance in the medication, including reports of a gel-like mass and black particles.

Strides Pharma Inc. is recalling 89,592 bottles that were distributed nationwide, according to reporting that cited the FDA’s recall information. The recall was initiated after the recalling firm received complaints about a gel-like mass and black particles in the children’s ibuprofen product, the FDA said.

The FDA has classified the action as a Class II recall, which the agency defines as a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The reports did not specify how the foreign material entered the product, and the FDA notice did not provide additional details beyond the complaints cited in the recall listing.

Gut Microbiome May Take Years to Recover From Antibiotic Use

U.S. News & World Report reported:

Antibiotics are often hailed as miracle drugs for their ability to wipe out dangerous infections, but new research suggests they leave a more lasting footprint on our bodies than previously thought. A study of nearly 15,000 adults found that certain antibiotics can alter the community of helpful bacteria in our digestive system for nearly a decade.

The research, led by a team at Uppsala University in Sweden and published March 11 in Nature Medicine, mapped the gut microbiome — the trillions of bacteria that live in our intestines — of close to 15,000 adults in Sweden.

A stool sample from each participant was analyzed and participants answered a detailed lifestyle and diet questionnaire. Then, using national drug registries, scientists could see exactly which medications people had taken years prior. They adjusted for other medication use and several characteristics known to affect the microbiome in order to see the effects of antibiotic use.

The results were surprising. For some antibiotics, even a single round of use was linked to decreases in bacterial diversity four to eight years later. Overall, the worst effects were seen in the first year after using an antibiotic.

Antibiotic Used in COVID Patients Tied to Increased Signs of Antibiotic Resistance

CIDRAP reported:

In the early months of the COVID-19 pandemic, nearly 75% of hospitalized COVID patients received antibiotics on admission, primarily because of limited treatment options and concerns about bacterial coinfections. One of those antibiotics was azithromycin, a macrolide antibiotic commonly used for respiratory infections. Use of azithromycin was driven in part by a study, now retracted, that suggested it could improve outcomes in COVID patients when used in combination with the antimalaria drug hydroxychloroquine.

Although subsequent trials would find the combination had no benefit for COVID patients, widespread azithromycin use continued for several months. Early in the pandemic azithromycin was “routinely used despite the absence of data supporting a clinical benefit,” according to Michael Pulia, MD, PhD, an emergency physician and associate professor at the University of Wisconsin-Madison School of Medicine and Public Health.

Now, in a new study this week in Nature Microbiology, Langelier and a team of US researchers show that, in addition to having no clinical benefit for COVID patients, use of azithromycin was associated with potentially harmful changes in the upper respiratory microbiome and increased expression of antibiotic-resistance genes after only one day of exposure.

Novo Nordisk’s High-Dose Wegovy Approved in the U.S.

STAT News reported:

A high-dose version of Novo Nordisk’s injectable obesity drug Wegovy received U.S. approval, the company said Thursday, providing it with a new catalyst as it tries to claw back market share with its weight loss treatments. The therapy was approved under a new voucher program that was set up by Food and Drug Administration Commissioner Marty Makary and that was intended to accelerate review of drugs that align with national priorities.

Novo received the voucher as part of its deal with the Trump administration late last year to lower prices of its obesity medicines in certain settings. Novo was first to open up the booming obesity market with Wegovy, but it’s fallen behind Eli Lilly in recent years, and it’s not clear how much high-dose Wegovy will help it become more competitive again.

In a Phase 3 trial, Wegovy at the high dose of 7.2 milligrams led to 18.7% weight loss, when looking at all patients, including those who discontinued. That’s more than the 15% weight loss that the standard Wegovy dose of 2.4 mg has shown, but falls slightly short of the 21% weight loss that Lilly’s rival product, Zepbound, has demonstrated.

Ozempic Is About to Go Generic for Billions of People

The New York Times reported:

The blockbuster weight loss drug sold as Ozempic and Wegovy will soon go generic in countries that are home to 40 percent of the world’s population, significantly lowering the price of a costly medicine that had been largely unaffordable to nearly all but the wealthiest people. On Saturday, Novo Nordisk, the company that until now has had a monopoly on selling the drug, will lose patent protection in several of the world’s most populous countries.

The first generic versions are expected to arrive in India as soon as this weekend. In the coming months, the generics are also expected to become available in China, Canada, Brazil, Turkey and South Africa. “The availability of these drugs, which have been restricted to high-income countries to very wealthy people, will now be democratized by the generics,” said Leena Menghaney, an activist in New Delhi focused on treatment access.

The new markets for generics are enormous. Together, India and China are home to more than 800 million adults who are obese or overweight and more than 360 million adults with diabetes.

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IPAK-EDU is grateful to The Defender as this piece was originally published there and is included in this news feed with mutual agreement. Read More