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October 6, 2023 Toxic Exposures

Researchers Link Popular Weight Loss Drugs to Serious Digestive Problems for ‘Hundreds of Thousands’ Worldwide + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Researchers Link Popular Weight Loss Drugs to Serious Digestive Problems for ‘Hundreds of Thousands’ Worldwide

CNN Health reported:

A new study suggests people taking popular injected medications for weight loss, including Wegovy, Ozempic, Saxenda and Victoza, may be at higher risk for serious digestive problems such as stomach paralysis, pancreatitis, and bowel obstructions, compared with those taking other types of weight loss medications.

The study found risks of these events happening to individual patients appear to be rare — about 1% of people taking Ozempic were diagnosed with stomach paralysis, for example. But demand for the drugs has exploded, with tens of millions now taking them worldwide. Researchers say even rare risks like these may amount to hundreds of thousands of new cases.

The study authors also note that these problems are not mild. Bowel obstructions, for example, can be medical emergencies. Previous CNN reporting highlighted cases of stomach paralysis in people who had taken these drugs and the lack of warning about that specific side effect to patients.

The prescribing information for Wegovy and Saxenda does caution about a host of serious side effects including inflammation of the pancreas, gallbladder problems, blocked intestines, kidney problems, serious allergic reactions, increased heart rate, suicidal thoughts, and changes in vision or people who also have diabetes. A warning about ileus, or blocked intestines, was also just added to Ozempic’s warning label.

FDA Expert Panel Endorses Idea of Removing a Component From Flu Vaccine

STAT News reported:

The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline.

While a representative of vaccine manufacturers warned it may not be possible to remove the influenza B/Yamagata component from the flu vaccines that will be made for the Northern Hemisphere’s 2024-25 season, several members of the Vaccines and Related Biological Products Advisory Committee suggested that should be a goal, at least for the U.S. market.

Arnold Monto, a veteran influenza expert from the University of Michigan, stressed that while there isn’t enough time left to recommend the B/Yamagata component be removed from vaccines soon to be made for the next Southern Hemisphere winter, it is possible manufacturers could clear the regulatory hurdles in time for the formulation of 2024-25 flu shots for the U.S. market. VRBPAC is scheduled to meet next March to vote on the 2024-25 winter flu vaccine composition.

Apellis Sales Numbers Show Steady Demand for New Eye Drug, Despite Safety Worries

BioPharma Dive reported:

Sales of Apellis Pharmaceuticals’ new eye drug Syfovre continued to climb in the third quarter, even after a series of reports linked the medicine to a potentially blinding condition called occlusive retinal vasculitis.

Syfovre in February became the first drug approved to treat geographic atrophy, a form of vision loss triggered by age-related macular degeneration. The drug launched in March, bringing in sales of $18.4 million in the first month that surpassed analyst expectations. The medicine’s fast start continued with revenue of $67 million in the second quarter.

The steady demand for Syfovre even amid side effect concerns reflects the great need for treatment options in the geographic atrophy market. When Syfovre first won approval, analysts predicted it could bring in peak annual sales of $3 billion.

Calls to Poison Centers for ADHD Medication Errors Have Risen 300% Since 2000, Study Finds

Fox News reported:

Amid rising diagnoses, a growing number of kids are getting prescriptions for ADHD medications — but the administered doses aren’t always accurate.

Medication errors for attention-deficit/hyperactivity disorder have risen by nearly 300% between 2000 and 2021 for people younger than 20 years old, according to a recent study at the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.

The study, published in the journal Pediatrics last month, evaluated the share of annual ADHD medication errors among kids and teens as reported to U.S. poison centers.

Overall, the researchers assessed 87,691 cases of prescription mistakes, according to a press release from Nationwide Children’s Hospital. That broke down to an average of 3,985 per year.

Dengue Will ‘Take Off’ in Southern Europe, U.S., Africa This Decade, WHO Scientist Says

Reuters reported:

Dengue fever will become a major threat in the southern United States, southern Europe and new parts of Africa this decade, the WHO’s chief scientist said, as warmer temperatures create the conditions for the mosquitoes carrying the infection to spread.

Jeremy Farrar, an infectious diseases specialist who joined the World Health Organization in May this year, previously spent 18 years working in Vietnam on tropical diseases including dengue. He later headed up the Wellcome Trust global health charity and advised the U.K. government on its COVID-19 response before joining the WHO in May this year.

Farrar said the infection is likely to “take off” and become endemic in parts of the United States, Europe and Africa — all regions where there has already been some limited local transmission — as global warming makes new areas hospitable to the mosquitoes that spread it. That will put acute pressure on hospital systems in many countries, he warned.

There is no specific treatment for dengue, although there is a vaccine available. Earlier this week, the WHO recommended Takeda Pharmaceuticals’ (4502.T) Qdenga vaccine for children aged 6 to 16 in areas where the infection is a significant public health problem.

Qdenga is also approved by the EU regulator, but Takeda withdrew its application in the United States earlier this year, citing data collection issues. Takeda said it was still in talks with the U.S. Food and Drug Administration about the vaccine.

U.S. FDA Still Not Satisfied With Philips Recall; Stock Falls Over 9%

Reuters reported:

The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips (PHG.AS) has handled a major product recall and the company should conduct additional risk testing.

Its shares fell 9.6% to 16.81 euros at 0726 GMT on Friday.

It was the latest blow to Philips over the recall of millions of sleep apnea and respiratory devices, which has been ongoing since 2021.

The recalled devices used a type of foam that could degrade when exposed to cleaning chemicals, causing injuries to airways or leading to cancer, the FDA has said. It has tallied 100,000 complaint reports over the machines, and 385 deaths.

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