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The warning, first introduced 22 years ago, cautioned that hormone replacement therapy could raise the risk of heart disease, stroke, blood clots, dementia, and certain cancers. The FDA now says newer evidence indicates that these risks are far lower when the treatment is prescribed before age 60 or within 10 years of the onset of menopause.

“We’re challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts,” said Health Secretary Robert F. Kennedy Jr. during the announcement.

The revision affects widely used therapies intended to ease symptoms such as hot flashes, night sweats, and mood changes—conditions that affect millions of women during menopause.

Updated Guidelines Reflect Evolving Science

FDA Commissioner Dr. Marty Makary, who has long advocated for removing the warning, called the previous label “outdated and unnecessary.” He said the decision aligns with findings from recent studies showing that hormone therapy can be safe and beneficial for many women when used appropriately.

“With few exceptions, there may be no other medication in the modern era that can improve women’s health outcomes at a population level more than hormone replacement therapy,” Makary told reporters.

The agency’s updated prescribing information now aligns with modern medical guidelines, which recommend using hormone therapy for a limited duration among younger women without complicating risk factors such as breast cancer or blood clotting disorders.

Still, not all experts agree. Dr. JoAnn Manson of Harvard Medical School said that while removing the warning was “a good step toward personalized care,” the benefits described by Makary are “not as conclusive or definitive.”

“The black box is really one size fits all—it scares everyone away,” Manson explained. “Without it, there can be more focus on how the risks and benefits differ by age and health profile.”

A Shift from Two Decades of Caution

The FDA’s original boxed warning was based on findings from the landmark Women’s Health Initiative (WHI) study, published in 2002, which linked hormone therapy to higher rates of heart disease, blood clots, and breast cancer.

The study, involving over 26,000 women, led to a dramatic decline in hormone therapy prescriptions across all age groups. In the 1990s, roughly one in four American women used estrogen-based treatments, often believing they could prevent heart disease and dementia.

However, later analyses of the WHI data have revealed more nuanced results. A new review published in September found that women in their 50s taking estrogen-based drugs did not face an increased risk of heart problems, while risks were higher for those in their 70s. For women in their 60s, the data remained inconclusive.

“These findings suggest that timing and age at initiation make a significant difference in outcomes,” said Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists. “The old warning scared patients away even when hormone therapy might have helped them.”

Fleischman added that many women stopped seeking treatment altogether after reading the label. “I can spend 30 minutes counseling someone about hormone therapy, but when they see that warning, they just get scared,” he said.

FDA’s Review Process Sparks Criticism

Despite widespread support from some physicians, the FDA’s approach to revising the warning has drawn criticism from several health policy experts who argue that the agency bypassed its usual advisory process.

Typically, the FDA consults independent advisory committees when revising safety labels. Instead, Makary convened a smaller, informal panel of about a dozen doctors and researchers—many of whom publicly advocate for hormone therapy or have ties to pharmaceutical companies that manufacture these drugs.

Diana Zuckerman, president of the nonprofit National Center for Health Research, said the decision risks undermining public trust. “By skipping a formal scientific meeting and instead holding a news event, the FDA appears to have prioritized messaging over transparency,” she said.

Makary defended the move, arguing that advisory committee meetings are “bureaucratic, long, often conflicted, and very expensive.”

New Labeling Still Includes Cancer Advisory

Although the FDA has removed the broader black box warning, the updated labels will still contain a boxed notice advising that women who have not had a hysterectomy should take a combination of estrogen and progestin to reduce the risk of uterine cancer.

The older warning language will remain on the label but appear in a less prominent section.

Additionally, the market has evolved since the early 2000s, with newer formulations delivering hormones in lower doses and through localized delivery systems such as vaginal creams and tablets. These methods limit how much hormone circulates through the bloodstream, potentially lowering systemic risks.

Ongoing Debate Over Hormone Therapy’s Role

The controversy over hormone therapy reflects broader debates in women’s health about how medical evidence is interpreted and communicated. Advocates say the FDA’s decision could help reduce stigma and make more women comfortable discussing treatment options. Critics warn that downplaying risks could lead to overprescription.

Medical experts emphasize that hormone therapy should be prescribed on an individual basis, taking into account age, health history, and symptom severity.

“The removal of the black box is not a green light for everyone,” Dr. Manson noted. “It’s an invitation to nuanced, evidence-based decision-making.”

As hormone therapy reenters public conversation, researchers say long-term studies are still needed to confirm whether the treatment can truly reduce the risk of chronic conditions like Alzheimer’s and heart disease—claims that remain scientifically unsettled.

Source: AP News – The FDA removes a long-standing warning from hormone-based menopause drugs

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Big Changes Coming to Cold & Cough Medicines
FDA Moves to Ban Phenylephrine in Pills & Syrups
Consumers Must Turn to More Effective Alternatives

Popular Cold Medicine Ingredient Doesn’t Work, FDA Says

Big changes are coming to your local pharmacy’s cold and cough aisle. The Food and Drug Administration (FDA) has announced plans to phase out phenylephrine, a leading decongestant found in hundreds of over-the-counter (OTC) medications, including Sudafed PE, DayQuil, and NyQuil.

The reason? It doesn’t actually relieve nasal congestion.

Despite being a common ingredient in cold and allergy medications, experts have questioned phenylephrine’s effectiveness for years. Now, the FDA has formally proposed revoking its use in oral pills and liquid solutions, meaning drugmakers will soon have to remove or reformulate their products.

Why Is the FDA Taking Action Now?

The decision comes after federal health advisers voted unanimously last year that phenylephrine does not work when taken orally.

Key Findings from FDA Experts:
Large, recent studies found phenylephrine was no better than a placebo at clearing nasal congestion.
Older studies from the 1960s and 1970s that initially supported the drug’s approval were found to be flawed and unreliable.
The $1.8 billion market for oral phenylephrine products could soon disappear.

Important Note: This decision only applies to oral phenylephrine (pills & syrups). Phenylephrine-based nasal sprays will remain available, as they are still considered effective.

What Are the Best Alternatives for Nasal Congestion?

With oral phenylephrine on the way out, what should you use instead?

Pseudoephedrine (Behind-the-Counter)

If you still prefer pills or syrups, you’ll need to ask for medications containing pseudoephedrine (the original decongestant in Sudafed).

Available behind the pharmacy counter (no prescription needed)
Found in Sudafed, Claritin-D, Allegra-D
More effective than phenylephrine

You must show a photo ID to purchase, due to laws preventing its misuse in methamphetamine production.

Nasal Sprays for Fast Relief

• Saline sprays & rinses (e.g., Neti pots) – Quickly clear mucus buildup.
• Nasal steroids (Flonase, Nasacort, Rhinocort) – Best for long-term congestion relief, but must be used daily for full effect.
• Antihistamine sprays (Astepro) – Act faster than steroids for short-term relief.

Why Doesn’t Oral Phenylephrine Work?

According to University of Florida researchers, phenylephrine is quickly broken down in the stomach, making it ineffective before it even reaches the bloodstream.

Dr. Leslie Hendeles, a leading researcher on phenylephrine, explains:
“This is a good drug, but not when it’s swallowed. It gets inactivated in the gut, so it can’t get to the nose.”

Even at doses 400% higher than currently recommended, phenylephrine still failed to relieve congestion. Increasing the dose even more could lead to dangerously high blood pressure, which is why the FDA ruled out stronger doses as an option.

What Happens Next?

The process to remove oral phenylephrine from store shelves won’t happen overnight.

Next Steps in the FDA Process:
6-month public comment period – Consumers & companies can submit feedback.
FDA review & final decision – Could take over a year for drugmakers to reformulate or remove products.
Possible delays – Drug companies may request additional hearings, slowing the process further.

Drugmakers Pushing Back

The Consumer Healthcare Products Association, which represents drug manufacturers, wants to keep phenylephrine available, arguing that consumers should have the right to choose their medications.

However, researchers like Dr. Randy Hatton (who co-led the FDA petition) disagree:
“Choosing from something that doesn’t work isn’t really a choice.”

What Should Consumers Do Now?

Avoid OTC pills labeled ‘PE’ – They won’t help your congestion.
Ask for pseudoephedrine at the pharmacy counter – It’s still available and works better.
Use nasal sprays & saline rinses – These provide fast and effective relief.
Consult your doctor or pharmacist – They can recommend the best alternative for your symptoms.

With the FDA cracking down on ineffective medications, consumers will soon have better options to actually relieve congestion. Stay informed and choose medications that truly work!

Source

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Introduction

In a significant decision, the U.S. Food and Drug Administration (FDA) has banned the use of Red Dye No. 3 (also known as erythrosine or FD&C Red No. 3) in foods, dietary supplements, and oral medicines. The move comes nearly 35 years after the dye was prohibited in cosmetics due to its potential cancer risks.

The Reason for the Ban

The FDA’s decision follows a 2022 petition filed by food safety and health advocates. The agency cited the Delaney Clause, a federal statute mandating the ban of any additive linked to cancer in humans or animals. Studies have shown that Red 3 caused cancer in lab rats exposed to high levels of the dye.

“The FDA is taking action to remove the authorization for FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, FDA’s deputy commissioner for human foods.

While the way Red 3 causes cancer in rats does not occur in humans, the FDA determined it was legally obligated to act based on existing evidence.

Transition Timeline for Manufacturers

The ban includes:

• Food Manufacturers: Required to remove Red 3 by January 2027.
• Ingested Drug Makers: Must comply by January 2028.

Imported foods must also adhere to the new U.S. requirements, though other countries still allow certain uses of the dye.

Consumer Advocates Celebrate the Move

Health and safety groups praised the FDA’s decision as a long-overdue step toward eliminating harmful substances from the food supply.

“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest (CSPI).

The CSPI spearheaded the petition, emphasizing that the dye’s removal is especially crucial for protecting children, who consume higher amounts of the additive relative to their body weight.

Potential Legal Challenges

The ban may face legal hurdles from food manufacturers. FDA Commissioner Dr. Robert Califf acknowledged this during a December 2022 hearing:

“When we do ban something, it will go to court. And if we don’t have the scientific evidence, we will lose in court.”

The FDA previously declined to revoke Red 3’s authorization for food in 1990, citing differences in how the dye affects rats and humans. This earlier decision has been a point of contention among health advocates and lawmakers.

Congress and Public Support

Nearly two dozen members of Congress pushed for the ban, stating it was vital to protect children and eliminate unnecessary carcinogens from the food supply. A November 2022 letter from lawmakers argued:

“The FDA should act quickly to protect the nation’s youth from this harmful dye, used simply to give food and drinks a bright red color. No aesthetic reason could justify the use of a carcinogen in our food supply.”

Public opinion aligns with this view. According to a recent AP-NORC poll, about two-thirds of Americans support restricting or reformulating processed foods to remove harmful additives like Red 3. Support is highest among:

• College-educated adults: 8 in 10 favor restrictions.
• Higher-income households: Roughly 7 in 10 support reformulation.

In contrast, only about half of adults with household incomes below $30,000 expressed support.

Looking Ahead

The FDA’s decision to ban Red Dye No. 3 marks a major milestone in food safety regulation, addressing long-standing concerns over its use. While the dye’s removal may face legal scrutiny, consumer advocates and lawmakers see it as a critical step toward ensuring healthier food options for all Americans.

Source

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The FDA announced Thursday that specialty pharmacies and online companies selling off-brand copies of two popular drugs for obesity and diabetes must phase out their versions by next year.

This decision comes after the Food and Drug Administration confirmed that the nationwide shortage of Eli Lilly’s blockbuster drugs, Zepbound and Mounjaro, has been resolved. The resolution eliminates the need for knockoff versions, which had become increasingly popular among Americans seeking weight loss solutions.

Lilly, which has been urging the FDA to take action for months, scored a victory with this ruling. The decision will likely change how patients access these medications and could affect the cost of treatment.

Resolving Shortages and Impact on Patients

Zepbound, approved for obesity treatment, and Mounjaro, approved for diabetes, both contain the active ingredient tirzepatide. The FDA confirmed Thursday that Lilly’s production of these drugs is now meeting or surpassing demand, effectively resolving a shortage that had lasted for over two years.

Both drugs belong to the GLP-1 class, known for their exceptional weight loss results by reducing appetite and increasing feelings of fullness. While Zepbound and Mounjaro are now in steady supply, competing GLP-1 drugs like Wegovy and Ozempic, from Novo Nordisk, are still facing shortages.

The explosive demand for GLP-1 drugs has led to the rise of compounding pharmacies and telehealth companies like Hims and Ro, which began offering cheaper alternatives. These knockoffs were typically sold online for several hundred dollars per month.

Phasing Out Knockoff Versions

Under the FDA’s new decision, businesses have between 60 and 90 days, depending on their size, to stop selling these off-brand products. The FDA allows compounded versions of brand-name drugs when there is a shortage, but with the supply of Lilly’s drugs now stable, the shift back to authorized medications is expected to improve consumer safety.

The FDA had warned patients last year about issues with the ingredients and formulations of some GLP-1 drugs sold online. Since compounding pharmacies are mainly overseen by state authorities, the FDA’s oversight in this area has been limited. Compounding pharmacies create customized medications by using raw drug ingredients, often for patients with specific allergies or needs. The growing industry has expanded into a multibillion-dollar business, especially amid increasing drug shortages.

The Role of Telehealth Companies

Telehealth companies, which have been aggressively marketing off-brand GLP-1 drugs, are also contributing to the growing demand. These companies operate outside the same marketing regulations as traditional drugmakers, which has led to increased concerns about the safety and quality of the products being sold.

Earlier in October, the FDA had declared an end to the Mounjaro and Zepbound shortage, but faced public backlash and a lawsuit from compounding pharmacies, prompting the agency to reverse its decision.

The new ruling from the FDA ensures that patients will now be able to access drugs that are both safe and properly regulated, marking a significant shift in how these popular treatments will be distributed moving forward.

Source

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Millions of teenagers in Africa are suffering from asthma with no formal diagnosis as the continent undergoes rapid urbanisation, researchers have found.

The study, published in the Lancet Child and Adolescent Health, involved 27,000 pupils from urban areas in Malawi, South Africa, Zimbabwe, Uganda, Ghana and Nigeria. It found more than 3,000 reported asthma symptoms, but only about 600 had a formal diagnosis.

Many of the children reported missing school or having their sleep disrupted by wheezing.

“If our data are generalisable, there are millions of adolescents with undiagnosed asthma symptoms in sub-Saharan Africa,” said Dr Gioia Mosler of Queen Mary University of London, the study’s research manager.

The team that led the study, whose research on the impact of pollution on lung health was instrumental in introducing the ultra low-emission zone (Ulez) in London, said there was an urgent need for medicines and diagnostic tests in the region.

Rates of asthma have increased in sub-Saharan Africa over the past few decades, a trend attributed to rapid urbanisation which exposes children to more risk factors such as air pollution. The climate crisis was also likely to have an impact, experts said.

The Achieving Control of Asthma in Children and Adolescents in Africa (Acacia) study recruited pupils aged between 12 and 14. Screening revealed that while 12% reported asthma symptoms, only 20% of that group had received a formal diagnosis of asthma.

Lung function tests suggested nearly half of undiagnosed participants with severe symptoms were “very likely” to have asthma.

Even among those who had received a formal diagnosis, about a third were not using any medicine to control their condition, according to the study.

Dr Rebecca Nantanda of Makerere University in Kampala, who led the research in Uganda, said: “Undiagnosed and poorly controlled asthma greatly impacts on the physical and psychosocial wellbeing of the affected children and their caregivers. The high burden of severe undiagnosed asthma revealed by the Acacia study requires urgent attention, including access to medicines and diagnostics.”

Prof Jonathan Grigg of Queen Mary University of London, said asthma was made worse by exposure to small particles of pollutants, with the impact of the climate crisis yet to become clear. “In some areas in sub-Saharan Africa, climate change is likely to result in increased exposure of these vulnerable children to dust and natural fires.

“On the other hand, climate change mitigation will, hopefully, reduce exposure to fossil fuel-derived particles in this region.

“The pharmaceutical industry has been hesitant to support asthma research and initiatives. For example, companies may feel that they cannot support research in countries where they do not intend to market their asthma product,” he said.

“Innovations such as handheld wheeze detectors and asthma clinics delivered at schools also have the potential to substantially reduce the burden of asthma.”

Source

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