Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

Acetaminophen Use During Pregnancy Linked With Language Delays, University of Illinois Study Finds

CBS News Chicago reported:

Most people might not hesitate to reach for Tylenol when they have a headache, but those who are pregnant might want to think twice.

A new study from researchers at the University of Illinois at Urbana-Champaign linked acetaminophen with language delays in children. Susan Schantz, professor emerita of comparative biosciences and one of the authors of the study, spoke to CBS 2 about the findings.

Schantz said the study looked at language development among children ages 2 and 3, and found that those whose mothers took acetaminophen, especially during the third trimester of their pregnancy, had smaller vocabularies and shorter sentence lengths. “So their language was delayed,” Schantz said.

She said the researchers are continuing to look into other aspects of the neurodevelopment in the children, including behaviors such as attention prevalence and attention-deficit/hyperactivity disorder (ADHD). They’re also planning to follow the children to see if the language delays they detected persist as the children get older.

FDA Looking Into Reports of Hair Loss, Suicidal Thoughts in People Using Popular Drugs for Diabetes and Weight Loss

CNN Health reported:

The U.S. Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications like Ozempic, Mounjaro and Wegovy.

These drugs, known as GLP-1 receptor agonists, are approved to treat diabetes or weight loss. They include semaglutide, branded as Ozempic, Rybelsus and Wegovy; liraglutide, branded as Saxenda and Victoza; and tirzepatide, branded as Mounjaro and Zepbound. They mimic GLP-1, a hormone made naturally in the body whose roles include slowing the passage of food through the stomach.

The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.

Some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs’ prescribing information or on their labels.

For months, European regulators have also been investigating the risk of suicidal thoughts in people taking these medications, although it’s not clear whether the medicines caused the events or whether they may be linked to other underlying conditions.

Roche Designs New Antibiotic to Fight Deadly A. Baumannii Infections

Fierce Biotech reported:

Researchers at Roche have developed a novel antibiotic with the ability to fight a dangerous drug-resistant bacteria that kills up to 60% of infections.

In a pair of articles published Jan. 3 in Nature, Roche and Harvard University scientists described how they developed a new antibiotic that is effective against carbapenem-resistant acinetobacter baumannii — also known as CRAB — in mice. The drug, zosurabalpin, works by interrupting the construction of the bacteria’s outer membrane.

CRAB is a common culprit in hospital-acquired sepsis and other infections, and is at the top of the list of both the World Health Organization’s and the Centers for Disease Control’s “priority pathogens” for which new drugs are urgently needed.

As its name implies, CRAB is resistant to all antibiotics including the last-resort drug carbapenem. While infections have declined in recent years thanks to preventative measures, according to the CDC’s 2019 report on antibiotic resistance, the bacteria killed 700 people in 2017 and added about $281 million in healthcare costs.

Review Shows COVID Vaccines ‘Significantly’ More Deadly Than Flu Shots: Sen. Ron Johnson

The Epoch Times reported:

An analysis of Vaccine Adverse Event Reporting System (VAERS) data indicates that the COVID-19 vaccines are “significantly” more deadly than the flu vaccine, according to Sen. Ron Johnson (R-Wis.). The review was conducted by the senator’s staff and involved a certain level of assumption given that no publicly available data exist regarding how many flu vaccine doses were administered in the United States over the past 10 years.

Using the number of distributed doses to generate that figure, they found that the number of deaths per million doses of the COVID-19 vaccines (25.5) far exceeded those estimated for the flu vaccine (0.46).

“Using the midpoint assumption that 70% of distributed flu vaccines were administered, the 25.5 deaths per million doses of the COVID-19 vaccine represents a 55-fold increase over the flu vaccine deaths per million doses,” Mr. Johnson wrote in a Dec. 21 letter to the heads of the Department of Health and Human Services, U.S. Food and Drug Administration, and Centers for Disease Control and Prevention.

“This is a shocking difference and only adds to the growing evidence of safety signals that are screaming to be taken seriously,” he added. The administration officials have been given until Jan. 18 to produce the requested information.

Novo Nordisk, Eli Lilly’s Obesity Drugs Will Lead in New Drug Sales in 2024: Evaluate

Fierce Pharma reported:

Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies — Novo Nordisk and Eli Lilly — overwhelming the market with their dominance.

Expect more of the same in 2024, according to a recent report from Evaluate, which places Novo and Lilly in the top two spots for global new sales. The analysts peg Novo’s sales increase to approach $8 billion in 2024, while Lilly’s will come in at close to $5 billion.

With the huge revenue gain, Evaluate also sees Novo crashing the top 10 list of pharma companies by sales in 2024, replacing GSK, with the Danish company expected to exceed $40 billion. The figure is more than double the sales that Novo generated in 2020 ($19.4 billion) and is even a massive boost from its revenue of 2022 ($25.1 billion), indicating how quickly demand for the weight-loss products has mushroomed.

Lilly Launches Website, Home Delivery Option for Weight-Loss Drug

Reuters reported:

Eli Lilly and Co (LLY.N) on Thursday launched a website that will allow people with obesity to get prescriptions through telehealth providers and opt for home delivery of the company’s weight-loss drug.

The service, called LillyDirect, comes on the back of the launch of Lilly’s obesity drug Zepbound last month, the latest entrant to a market that is forecast to grow to about $100 billion by the end of the decade.

“We’re used to buying consumer goods directly from manufacturers all the time on online websites,” Lilly CEO David Ricks told NBC News. “It really hasn’t been an option that’s been provided before” for prescription drugs, Ricks added.

Mounjaro Gastroparesis Lawsuit Filed Against Eli Lilly for Failing to Warn About Stomach Paralysis Side Effects

AboutLawsuits.com reported:

Eli Lilly faces a new product liability lawsuit, which claims that users and the medical community have not been adequately warned about potential Mounjaro gastroparesis side effects, which have caused some users of the blockbuster drug to develop severe vomiting, dehydration and other injuries.

The complaint was brought last week by Robert McDonald in the U.S. District Court for the Southern District of Mississippi, indicating that the manufacturer of the diabetes and weight loss drug knew or should have known about the potential risks from clinical trials, medical literature and case reports submitted by users, yet withheld the critical information to boost sales.

A separate version of Ozempic was previously approved by the FDA specifically for weight loss, which is marketed under the brand name Wegovy (semaglutide), and Eli Lilly just recently obtained approval to market a weight-loss version of Mounjaro under the brand name Zepbound.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Mounjaro lawsuits, Ozempic lawsuits and Wegovy lawsuits against the manufacturers, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to adequately warn about the risk of severe and long-lasting gastroparesis side effects.

Health Officials in Suffolk County, New York, Report Whooping Cough Outbreak Over the Last Month

ABC News reported:

Health officials in Suffolk County, New York, are warning the public that cases of the respiratory bacterial infection called pertussis, also known as whooping cough, have been on the rise in the area.

In Suffolk County, 108 cases of pertussis were reported or suspected in 2023. One hundred of those cases have been reported since November 28, 2023, a spokesperson for the Suffolk County Department of Health Services told ABC News.

Officials say there have been no known hospitalizations to date, and this outbreak has been mostly among vaccinated children and their parents, according to a press release.

Brazilian City Begins First Mass Vaccination Against Dengue

Reuters reported:

The city of Dourados in the Brazilian state of Mato Grosso do Sul on Wednesday began the country’s first mass vaccination against dengue, the city’s government said.

The initiative aims to vaccinate around 150,000 residents of the city between the ages of 4 and 59 using the recently approved Japanese drugmaker Takeda’s (4502.T) vaccine QDENGA.

Distribution started on Wednesday of the first batch of 90,000 doses already delivered by the Japanese laboratory as part of an agreement with the city. The vaccination schedule requires a second dose in three months.

AstraZeneca, Sanofi RSV Infant Shots Approved in China

Reuters reported:

AstraZeneca (AZN.L) said on Tuesday that its respiratory syncytial virus (RSV) immunization for infants developed with Sanofi (SASY.PA) has gotten approval in China.

The drug makers co-developed the RSV shot for infants and toddlers called Beyfortus, which has already been approved for use in the European Union and United States.

Beyfortus is expected to be available in China during the upcoming 2024-2025 RSV season, the London-listed drugmaker said in a statement.

Regulatory applications for the drug are currently under review in Japan and several other countries, the company added.