FDA approves breakthrough drug to treat advanced pancreatic cancer

(NEW YORK) — As Venezuela continues to recover from powerful twin earthquakes that rocked the north-central part of the country in late June, humanitarian organizations are warning of a “dire” situation on the ground.

The earthquakes, which officials say killed more than 4,400 people and injured more than 16,000, have displaced thousands of Venezuelans.

Aid workers told ABC News that countless people are in need of psychosocial support, in addition to those recovering from earthquake injuries.

Many Venezuelans are also suffering from chronic conditions — such as diabetes and hypertension — and are struggling to get care in the aftermath of the natural disaster.

Additionally, there has been a rise in reports of skin conditions and gastrointestinal diseases due to a lack of clean water and poor sanitation conditions, the workers said.

“The situation on the ground is pretty dire in terms of humanitarian needs,” Aisha Majid, a media manager at the international NGO Save the Children who is currently based in Caracas, told ABC News. “I’ve been here for a week, and there are thousands of families who are displaced on the streets.”

Mobile clinics treating wide range of conditions

Aid workers told ABC News that hospitals in Venezuela are currently overwhelmed treating people injured by the earthquakes, adding that some of the backlog predates the earthquakes.

“There are thousands of patients seeking help, and there aren’t enough doctors or hospitals or primary healthcare facilities,” Claudia Manresa, a regional compliance legal manager for the humanitarian organization Project HOPE in Latin America who is based in Venezuela, told ABC News. “There also aren’t enough medications, so this crisis joins a system that was already overwhelmed.”

Mobile clinics have been helping to fill some of the gaps. Manresa said Project HOPE has two mobile medical units running every day and, as of July 9, they have treated about 2,000 patients.

Save the Children is running a mobile clinic treating both patients with earthquake-related injuries, as well as other health needs including infections and chronic conditions. Majid said the organization is hoping to set up several mobile clinics across the capital of Caracas and the city of La Guaira, which was hit hard by the earthquakes.

Majid recalled that she visited a mobile clinic earlier in the month that Save the Children ran on the northeastern outskirts of Caracas through a local partner, which treated about 150 patients in around four hours.

“The second the clinic opened, there was a queue of people waiting to receive services, which just tells you how much in need people are, and the doctors in the clinic were working nonstop all day, just seeing patient after patient,” she said.

Everardo Esquivel, associate director for communications for the International Rescue Committee (IRC), told ABC News that many healthcare facilities were damaged in the earthquakes. As a result, he said people lost access to primary care and follow-up care.

Thirty-eight hospitals were damaged by the earthquakes, with the main referral hospital in La Guaira exceeding capacity within one day, according to the IRC.

The IRC’s mobile medical unit has been trying to help manage the increase in patient care, providing medicine for those with chronic conditions, including hypertension and diabetes, as well as antibiotics for certain conditions, he said.

Esquivel explained that there’s been a rise in skin conditions and diarrheal diseases due to the lack of clean water in the aftermath of the earthquake. Many shelters have virtually no access to toilets or showers, he said.

“People don’t have access to clean water and to properly clean wounds every day, so they get infections,” he said. “So, it’s two cases [at the mobile clinics]: it’s people with chronic diseases or in need of regular treatment and people who got new diseases related to the situation after the earthquakes.”

Need for psychosocial support

Humanitarian workers told ABC News there are also mental health issues that may arise after the earthquakes.

The World Health Organization said almost all people affected by emergencies experience psychological distress, which generally improves over time, but a fraction of people will go on to develop mental health conditions.

Manresa said Project HOPE is providing what aid workers refer to as psychological first aid, with a psychologist team deployed in La Guaira, offering different activities for kids and for adults.

She said the organization also has several phone lines that people can contact if they need help.

Children are particularly vulnerable. After a disaster, they may develop mental health symptoms including anxiety, depression and post-traumatic stress disorder (PTSD), according to the Centers for Disease Control and Prevention (CDC).

A 2017 review of eight studies of children following natural disasters found that 4% to 23% experienced chronic symptoms, with persistently elevated PTSD over time.

Majid, with Save the Children, said she’s met several children who are experiencing trauma after the earthquake.

Majid recalled meeting an 11-year-old boy who told her he’s scared when he sees cracks in the ground because he thinks it means the Earth will open again. She noted that another boy told her he’s scared to use the bathroom nearby because there is a crack in it.

“What we’re seeing is that there is a huge need for psychological support for children, and this is something that we provide through safe spaces that we run in affected areas,” Majid said. “And this is a place where children can come, they can play for a while.”

She noted that the organization has psychologists and specialists in mental health working with the young people there.

“It’s so important that children not only have a place where they can play but a place where they can also safely express their emotions and find a way to connect with the trauma and the grief that so many of them have been through,” she said.

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(BOSTON) — About 4,000 registered nurses at Brigham and Women’s Hospital (BWH) in Boston voted “overwhelmingly” on Thursday to authorize an open-ended strike.

The Massachusetts Nurses Association (MNA), which represents the nurses, said this could be the largest open-ended registered nurse (RN) strike in state history.

No strike date has been set yet. Before it occurs, the nurses will be legally required to give 10 days’ notice. If the strike is held, it would continue until the nurses reach a contract agreement with the hospital.

Nurses say they are seeking a fair contract that will protect patient care, strengthen the workforce and provide affordable health insurance.

“[Mass General Brigham] cannot tell nurses to choose between the care our patients deserve, affordable health insurance, or fair cost-of-living wage increase,” Jim McCarthy, RN, a nurse in the post-anesthesia care unit and vice chair of the BWH MNA Bargaining Committee, said in a statement.

The statement went on, “We have offered to negotiate and work toward an agreement, but CEO Anne Klibanski, who makes $9.2 million a year, and the billionaires on MGB’s Board of Directors, have refused to bargain. Our vote gives nurses the power to push back hard if the MGB billionaires keep putting corporate greed over safe patient care.”

Among the nurses’ proposals are limiting the hospital’s use of temporary nurses, fair compensation including a cost-of-living increase and affordable health insurance with plan choice.

In July, BWH nurses held a one-day strike. Since then, the nurses say the hospital has refused to “meaningfully negotiate.”

MNA said that the hospital told nurses in August it was not willing to negotiate unless significant changes were made to the latest proposal.

“Brigham nurses have made clear that we are prepared to stay on strike for as long as it takes to win a contract that protects our patients and respects the nurses who care for them,” Kelly Morgan, RN, a labor and delivery nurse and chair of the BWH MNA Bargaining Committee, said in a statement.

“An open-ended strike is a serious step that will undoubtedly create a healthcare crisis in Massachusetts. MGB can prevent the strike by returning to the table and negotiating the contract our nurses need to keep providing world-class care,” the statement continued.

BWH did not immediately return ABC News’ request for comment.

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Dozens of Americans have filed personal injury lawsuits against the makers of popular GLP-1 drugs, like Ozempic, Wegovy and Mounjaro, claiming they were not properly warned of the risk of a rare type of sudden vision loss, called nonarteritic anterior ischemic optic neuropathy, or NAION, when taking the medications.

Researchers have been studying a possible link between GLP-1 drugs and this eye condition in recent years after a possible safety signal was reported from a single health center in Boston in 2024, but so far, no study has proven these drugs are the cause.

Novo Nordisk, the maker of Ozempic and Wegovy, said they take “all reports of adverse events very seriously,” and pushed back against these claims, stating, “Novo believes the personal injury lawsuits filed in the U.S. are without merit and are vigorously defending them,” a spokesperson told ABC News.

Adding, “Novo is committed to patient safety and continuously monitors the safety profile of our GLP-1 RA products. Should emerging safety data warrant further action, appropriate measures will be implemented in accordance with regulatory requirements.”

A spokesperson for Lilly, who manufactures Zepbound and Mounjaro, told ABC News, “Patientsafety is Lilly’s top priority. We actively monitor, evaluate, and report safety information for all our medicines to the FDA. As part of our routine safety review process, we have ongoing discussions with regulators regarding potential safety topics, and we will continue to review data, including any data regarding ophthalmic issues.”

Here’s what GLP-1 users should know about this condition and what the science says.

What is NAION?

Although a rare condition overall, Dr. John Chen, a professor of ophthalmology and neurology at Mayo Clinic, said, “NAION is the most common acute optic neuropathy in patients over the age of 50. It’s essentially a lack of blood flow to the optic nerve, where patients typically have pretty acute onset of painless vision loss.”

That vision loss is usually permanent, and there is no specific treatment for the condition at this time, Chen told ABC News.

Dr. Raj Maturi, clinical spokesperson for the American Academy of Ophthalmology and ophthalmologist at Midwest Eye Institute, told ABC News that people with diabetes, regardless of GLP-1 use, can be at increased risk of developing this condition, and other risks include overnight low blood pressure or a very small optic nerve cup.

Vision problems are listed as possible side effects of these medications, but the Food and Drug Administration does not currently require the drug makers to list NAION as a specific risk.

The agency’s Sentinel Initiative does say a review is ongoing that aims to scientifically evaluate the possible safety signal related to GLP-1 drugs and NAION that is still in progress.

In a statement provided to ABC News, a spokesperson for the FDA said, “The FDA routinely monitors the safety of drug products postmarketing. The FDA identifies safety signals from a variety of sources, evaluates the available data and takes regulatory actions when appropriate.”

Other countries have required the drug makers to include a warning that there may be a possible increased risk of developing NAION if taking some of these medications based on their review of available evidence, including the European Medicines Agency and Australia’s Therapeutic Goods Administration, both citing it as a rare possible side effect.

In general, safety signals don’t alwayspan out as true risks for all medications and not every possible side effect is caused directly by the medication itself.

Drugs that are FDA-approved undergo rigorous clinical trials, are heavily scrutinized before reaching the market, and post-marketing safety is continuously monitored.

What does the science say?

“Several studies suggest that there is a potential link between NAION, or eye stroke, and GLP-1 use,” Maturi said. “However it is important to note that causation has not been proven. And the risk does seem to be rare,” Maturi said.

In 2024, researchers at a single health system in Boston published data that suggested people with type 2 diabetes who were prescribed semaglutide, a GLP-1 receptor agonist and the active ingredient in Ozempic and Wegovy, may be at increased risk of developing this type of vision loss.

Since then, more research has been done with larger studies that have shown mixed results as to whether a link does exist, and no study to date has proven that these medications cause this eye condition.

“There are significant benefits from the GLP-1’s for severe obesity, diabetes, cardiovascular disease. That’s proven time and time again with these randomized clinical trials,” Chen said. “We didn’t have to pull the plug on those trials because people were going blind. So again, if there is an association, it’s a very low risk.”

The European Medicines Agency estimates this eye condition could possibly impact 1 out of every 10,000 GLP-1 users who have diabetes, based on their analysis of available information.

In a joint statement, the North American Neuro-Ophthalmology Society and the American Academy of Ophthalmology said, “While many report a small possible increased risk of NAION in patients taking GLP-1 RAs such as semaglutide, some studies report no correlation, and the overall magnitude of the risk of NAION remains low.”

Maturi and Chen both said that the data isn’t conclusive so far and more research is needed to understand if GLP-1 drugs have a true role in developing NAION.

What should GLP-1 users do?

Doctors recommend that people always discuss any potential side effects of a medication with their own doctor and warn that there are proven health risks, including eye problems, if diabetes and obesity go untreated.

“For any patients already taking semaglutide who have not experienced any symptoms, they should continue to do so as instructed and discuss any questions or concerns with their primary care physician,” Maturi said.

Chen said he doesn’t believe this potential risk should prevent most people from using GLP-1 medications if they are recommended by a doctor to help treat an underlying health condition but cautions that people who have experienced NAION in one eye already may need to weigh the possible risks more closely with their doctor.

“We’re not sure if the GLP-1 is connected or not. We know this helps with diabetes, heart disease, and severe obesity,” Chen said. “We essentially don’t want you to stop your meds without talking to your doctor, and if you do have sudden painless vision loss, you should be seen by an eye doctor.”

Jade A. Cobern, MD, MPH, is a practicing physician, board-certified in pediatrics and general preventive medicine, and is a fellow of the ABC News Medical Unit. ABC News’ Elizabeth Schulze also contributed to this reporting. 

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