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December 22, 2023

Big Pharma News Watch

Ozempic and Wegovy Gain Popularity for Weight Loss, Also Cause Spike in Emergency Calls for Adverse Side Effects + 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.

Ozempic and Wegovy Gain Popularity for Weight Loss, Also Cause Spike in Emergency Calls for Adverse Side Effects

CBS News reported:

Medications initially created to help those living with Type 2 diabetes are now causing more people to have side effects, according to Banner Health. Ozempic and Wegovy, two medications originally designed for treating diabetics, have gained popularity among those hoping to lose weight as well.

While the drugs have proven successful at helping many lose weight, Banner Health has also seen a 100% increase in calls to the poison and drug center when it comes to those using the drugs experiencing other adverse reactions.

While the drugs have proven useful for many in their weight loss journey, doctors note that stopping the medication will in most cases result in consumers gaining all of the weight back. More concerningly, Samuel Saltz, a doctor with Banner Health in Fort Collins, said many who started taking the medications have had to go to the emergency room with other symptoms.

“It can cause gallbladder disease and diarrhea. Those kinds of things will lead to dehydration which will lead to an ER visit,” Saltz said.

Fewer in Florida Are Getting New COVID Shot. Why They’re Refusing — and What It Means

Miami Herald reported:

Fewer people in Florida are getting COVID shots this year despite updated vaccines, aggressive ads and reminders from drugstores and drug companies. At the same time, public health authorities are closely watching the spread of a more contagious COVID variant spreading across the country.

But even as pharmacies and pharmaceutical firms hard-press the new COVID shots with frequent TV ads and frantic phone texts, there’s vaccine weariness and wariness in Florida. Many people are worried about possible side effects or aren’t worried about a COVID threat. And they’re not getting the shot.

The vaccine rate in Florida is low — 5% of the population has taken the COVID shot since the September rollout, according to Miami Herald calculations of vaccine data from the Florida Department of Health. The CDC estimates about 11% of adults and about 7% of kids in Florida are vaccinated with the new shot.

Since the first doses of Pfizer and Moderna vaccines were administered, demand for shots has gone down. Fewer and fewer Florida residents turned out to receive each new booster as they rolled out, according to Herald calculations of CDC data.

FDA Approves First-Ever DNA Test to Help Screen for Risk of Opioid Use Disorder

The Hill reported:

The first-ever DNA test to help determine if someone has a greater risk of developing opioid use disorder was approved by the Food and Drug Administration (FDA) this week.

The FDA approved the AutoGenomics AvertD test for use among adults who are considering treating acute pain with a short-term prescription of opioid pain medicine, such as after a planned surgery.

The test is not intended to be used by patients being treated for chronic pain. The information from the test may help patients make better-informed decisions, the FDA said. The agency stressed the information should be used as part of a complete clinical evaluation and risk assessment and shouldn’t be used alone to make treatment decisions.

The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder.

FDA Finalizes New Mandatory Opioid Addiction Risk Label Warnings

AboutLawsuits.com reported:

New mandatory warning labels will be required for all opioid painkillers, as part of a continuing effort by federal drug regulators to curb misuse and abuse of the powerful and addictive narcotic painkillers. The new label requirements were proposed in April 2023, in response to the nation’s opioid crisis, with nearly 70% of all fatal drug overdoses in the U.S. involving opioid painkillers.

The new label requirement also includes a new warning about opioid-induced hyperalgesia, a potential side effect of opioid use that leads to an increase in pain or increased sensitivity to pain.

The warning labels will also provide information on determining which symptoms are a part of opioid-induced hyperalgesia and which symptoms result from opioid tolerance and withdrawal, a serious concern among patients who begin to abuse prescription painkillers.

Opioids now account for nearly half of all fatal child poisonings in the U.S. Comparatively, in 2005, opioids accounted for roughly 24% of all child poisonings in the country.

Exclusive: India Probe Into Bribery Claim in Toxic Syrup Tests Nears Completion

Reuters reported:

India is close to finishing an investigation into a “comprehensive and exhaustive” complaint that a state drug regulator, in return for a bribe, helped switch samples of cough syrups linked to the deaths of children in Gambia before the samples were tested in India, the investigator told Reuters.

While the World Health Organization (WHO) linked the syrups made by India’s Maiden Pharmaceuticals to the deaths of 70 children in the African country last year, India’s government says tests at an Indian government laboratory showed the syrups were not toxic. Maiden has said it had not “done anything wrong.”

Editor’s Corner: The Top 10 Fierce Pharma Marketing Stories of 2023 Recapped

Fierce Pharma reported:

In 2023, you, our readers, have continued to show keen interest in how pharmaceutical companies market their COVID-related products. The impact of COVID remains a dominant theme, evident in the top 10 most-read stories for Fierce Pharma Marketing. But between the lines, there has been a subtle shift in focus to a new area in the form of anti-obesity medicines that we didn’t see in 2022.

The second most-read story brings us back to COVID and Pfizer, a major double act this year, involving both the COVID vaccine and the drugmaker’s collaboration with musical artist Pink, drummer, filmmaker and singer Questlove, actor Jean Smart, and Olympic gold medalist swimmer Michael Phelps. They were tapped to promote Pfizer‘s COVID efforts in an ad released back in January.

Pfizer, which has for the past few years undertaken a soft approach when it comes to COVID promotion, hit the marketing gas pedal this year as it attempted to reverse a huge drop in sales for its vaccines and drug.

However, the efforts didn’t work, and the revenue drop continued. In fact, in November, the sales slump compelled Big Pharma to announce that it would need to make at least $4 billion worth of cuts by the end of 2024 to shore up its COVID losses. This may mean less money in the coffers for big celebrity ads in 2024.

Securing the final podium place for the most-read stories of 2023 is another Pfizer celebrity COVID ad. This time, it features Martha Stewart brandishing a giant sword, urging us to “Kill COVID-19” in a Quentin Tarantino throwback.

J&J, Legend’s Carvykti Slapped With FDA Black-Box Warning Over Secondary Cancer Risk

Fierce Pharma reported:

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers following the use of Johnson & Johnson and Legend Biotech’s Carvykti.

The boxed warning on Carvykti’s label includes a new item stating that “secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred following treatment with Carvykti.” Legend disclosed the label update in a securities filing Thursday.

A boxed warning is the FDA’s most serious safety-related warning for drugs on the market. Previously, the risk of secondary malignancies was listed in the “Warnings and Precautions” section of Carvykti’s label. This section is lower and not as prominent as a boxed warning.

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