Health

Concerns Remain for ‘Viagra for Women’ Twice Rejected by FDA

Published

11 years ago

June 2, 2015

In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. Sprout Pharmaceuticals, the makers of the twice-rejected pill intended to boost libido in women, will make a third attempt this week at convincing regulators to approve the drug as the first prescription treatment for low sexual desire in women. A panel of FDA experts will discuss the drug at a public meeting Thursday, June 4, 2015 before voting on whether to recommend its approval.(AP Photo/Allen G. Breed, File)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.

But a new review released by the Food and Drug Administration shows government scientists still have concerns about whether the drug’s benefits outweigh its risks. The FDA review highlights several safety issues with flibanserin, including low blood pressure and fainting spells. Those problems increased when patients combined the drug with alcohol and some other medications, according to the document.

A panel of FDA experts will discuss the drug at a public meeting Thursday, before voting on whether to recommend its approval.

The ongoing saga of Sprout Pharmaceutical’s much-debated drug illustrates the complex politics and science surrounding women’s sexuality.

For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men’s erectile dysfunction by increasing blood flow. But disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.

Supporters of Sprout’s drug say women’s sexual disorders have been long overlooked by the FDA. But critics argue that drug development efforts like Sprout’s medicalize women’s sexual problems, which are often related to stress, relationship issues and other life circumstances.

“There are certainly women who have low libido and are distressed by it,” says Dr. Adriane Fugh-Berman, an associate professor at Georgetown University. “But for those women therapy is the best solution, because this is not a medical disease.”

Other critics say they would support a safe and effective drug for treating women’s libido problems, but none has yet emerged.

“If a company could show that a drug is effective based on clinically significant outcome measurements, then we’d be for it,” says Cindy Pearson, executive director of the National Women’s Health Network.

Flibanserin is the first drug to approach the issue through brain chemistry. Originally studied as an antidepressant, the pill was repurposed as a libido treatment after women in company studies reported higher levels of sexual satisfaction. But the FDA has twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.

Clinicians who helped study flibanserin point out that they already prescribe other antidepressants without FDA approval to treat sexual desire disorders. They argue that those drugs, including Wellbutrin and Viibryd, carry worse side effects than flibanserin, such as agitation and seizures.

“We use them all the time for female sexual dysfunction,” says Dr. James Simon, a gynecologist who helped conduct several key studies of flibanserin. “The problem is that the side effect profile for doses that are effective for increasing desire and orgasm can be very high.”

Simon says the lack of an FDA-approved option for female sexual dysfunction means doctors must balance issues of safety and lack of insurance coverage while trying to help patients.

“We’re out there in the trenches every day trying to find a happy medium.”

It’s not entirely clear how flibanserin increases desire, but researchers point to its ability to boost dopamine — a brain chemical associated with appetite — while lowering serotonin, which is linked to feelings of satiation.

The FDA first rejected flibanserin in 2010 after a panel of expert advisers unanimously voted against the drug, saying its benefits did not outweigh its risks. Company studies showed women taking flibanserin reported roughly one more sexually satisfying experience per month than women taking placebo.

The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout, a startup company from Raleigh, North Carolina. Sprout resubmitted the drug with additional effectiveness and safety data, but the FDA again rejected the drug in October 2013. Sprout submitted the drug yet again earlier this year after filing a formal dispute over the FDA’s second rejection.

FDA’s review posted Tuesday underscores the ongoing rift between regulators and the company. The FDA acknowledges that flibanserin resulted in statistically significant increases in sexual events and desire, while decreasing distress. But the review concludes: “The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment.”

The FDA will ask its expert panel whether extra safety measures — including certification for doctors who wish to prescribe the drug — should be required if the drug is approved.

The FDA is not required to follow the advice of its panelists. The agency is expected to make a decision on whether to approve the drug in August..

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COMMENTARY: The Biases We Don’t See — Preventing AI-Driven Inequality in Health Care

For decades, medicine promoted false assumptions about Black bodies. Black patients were told they had lower lung capacity, and medical devices adjusted their results accordingly. That practice was not broadly reversed until 2021. Up until 2022, a common medical formula used to measure how well a person’s kidneys were working automatically gave Black patients a higher score simply because they were Black. On paper, this made their kidneys appear healthier than they truly were. As a result, kidney disease was sometimes detected later in Black patients, delaying critical treatment and referrals.

Published

2 months ago

February 10, 2026

Oakland Post

Sen. Akilah Weber Pierson, M.D (D-San Diego). File photo.

By Sen. Akilah Weber Pierson, M.D., Special to California Black Media Partners

Technology is sold to us as neutral, objective, and free of human flaws. We are told that computers remove emotion, bias, and error from decision-making. But for many Black families, lived experience tells a different story. When technology is trained on biased systems, it reflects those same biases and silently carries them forward.

We have seen this happen across multiple industries. Facial recognition software has misidentified Black faces at far higher rates than White faces, leading to wrongful police encounters and arrests. Automated hiring systems have filtered out applicants with traditionally Black names because past hiring data reflected discriminatory patterns. Financial algorithms have denied loans or offered worse terms to Black borrowers based on zip codes and historical inequities, rather than individual creditworthiness. These systems did not become biased on their own. They were trained on biased data.

Healthcare is not immune.

These biases were not limited to software or medical devices. Dangerous myths persisted that Black people feel less pain, contributing to undertreatment and delayed care. These beliefs were embedded in modern training and practice, not distant history. Those assumptions shaped the data that now feeds medical technology. When biased clinical practices form the basis of algorithms, the risk is not hypothetical. The bias can be learned, automated, and scaled.

For us in the Black community, this creates understandable fear and mistrust. Many families already carry generational memories of medical discrimination, from higher maternal mortality to lower life expectancy to being dismissed or unheard in clinical settings. Adding AI biases could make our community even more apprehensive about the healthcare system.

As a physician, I know how much trust patients place in the healthcare system during their most vulnerable moments. As a Black woman, I understand how bias can shape experiences in ways that are often invisible to those who do not live them. As a mother of two Black children, I think constantly about the systems that will shape their health and well-being. As a legislator, I believe it is our responsibility to confront emerging risks before they become widespread harm.

That is why I am the author of Senate Bill (SB) 503. This bill aims to regulate the use of artificial intelligence in healthcare by requiring developers and users of AI systems to identify, mitigate, and monitor biased impacts in their outputs to reduce racial and other disparities in clinical decision-making and patient care.

Currently under consideration in the State Assembly, SB 503 was not written to slow innovation. In fact, I encourage it. But it is our duty must ensure that every tool we in the healthcare field helps patients rather than harms them.

The health of our families depends on it.

About the Author

Sen. Akilah Weber Pierson (D–San Diego) is a physician and public health advocate representing California’s 39th Senate District.

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As California Hits Aging Milestone, State Releases Its Fifth Master Plan for Aging

“California’s Master Plan for Aging started a powerful movement that is shaping the future of aging in our state for generations to come,” Gov. Gavin Newsom said in a statement, calling the initiative a “future-forward” model delivering real results for older adults, people with disabilities, and their families.

Published

2 months ago

February 9, 2026

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iStock.

By Bo Tefu, California Black Media

On Jan. 27, California released its Fifth Master Plan for Aging Annual Report,titled “Focusing on What Matters Most,” outlining the state’s progress and priorities as its population rapidly grows older.

The report, issued by the California Health and Human Services Agency (CalHHS), provides updates on the Master Plan for Aging’s “Five Bold Goals”: housing, health, inclusion and equity, caregiving, and affordability.

The report comes as Californians aged 60 and older now outnumber those under 18 for the first time, a demographic shift expected to accelerate over the next decade.

Launched in 2021, the Master Plan for Aging takes a “whole-of- government” and “whole-of-society” approach, coordinating state agencies, local governments, community organizations, and private partners. The annual report highlights significant milestones, including more than 100 California communities joining AARP’s Age-Friendly Network and $4 million in state funding awarded to local organizations to develop aging and disability action plans in 30 communities statewide.

The report also underscores California’s leadership at the national level, noting that dozens of states have followed its example and that federal legislation inspired by the plan was reintroduced in the U.S. Senate in December 2025.

CalHHS Secretary Kim Johnson emphasized the plan’s focus on equity and resilience amid ongoing challenges.

“The Master Plan for Aging continues to provide a vision, a focus, and a platform for collaboration,” Johnson said. “Equity is at the center of all that we do.”

Looking ahead, the report notes that by 2030, one in four Californians will be age 60 or older, positioning the Master Plan for Aging as a central framework for meeting the state’s long-term social, economic, and health needs.

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Candidates Vying for Governor’s Seat Debate at Ruth Williams–Bayview Opera House in San Francisco

The gubernatorial debate participants included Antonio Villaraigosa, former Los Angeles mayor; Matt Mahan, San Jose mayor; Betty Yee, former California state controller; Xavier Becerra, former U.S. Secretary of Health and Human Services, and attorney general of California; Steve Hilton, political commentator and political adviser; Tom Steyer, entrepreneur, and Tony Thurmond, California’s superintendent of public instruction.

Published

2 months ago

February 9, 2026

Oakland Post

The gubernatorial debate was hosted by KTVU’s Greg Lee, KTTV’s Marla Tellez and KTVU’s Andre Senior. The candidates are (l.-r.): Xavier Becerra, Steve Hilton, Matt Mahan, Tom Steyer, Tony Thurmond, Antonio Villaraigosa, and Betty Yee.

By Carla Thomas

On Tuesday, Feb. 3, seven candidates took the stage at the historic Ruth Williams–Bayview Opera House in San Francisco for the gubernatorial debate, hosted by the Black Action Alliance (BAA) in partnership with KTVU and sister station KTTV Fox 11 in Los Angeles.

For many voters, it marked a first opportunity to hear directly from several candidates seeking to lead the nation’s most populous state.

Crucial topics and issues addressed throughout the debate included housing, crime, immigration, climate change, health care and homelessness.

The debate was moderated by KTVU political reporter Greg Lee alongside KTVU’s Andre Senior and KTTV Fox 11’s Marla Tellez.

Candidates also addressed inflation and the rising costs across the state, impacting everything from groceries to childcare and health care.

Thurmond vowed to generate 2.3 million units of housing by placing 12 units on each parcel of available land in the 58 counties of California. Steyer agreed that billionaires should pay their fair share of taxes.

Hilton wanted to cut taxes, help working-class families, and end the Democrats “climate crusade and insane regulations.”

Yee offered a more transparent governmental approach with accountability, given the state’s debt.

Gonzalez said, “This debate was a great way to see who has great ideas and who has substance.”

“It’s important to have the debate within a community that requires the most,” said business leader Linda Fadekye.

Attendees included State Controller Malia Cohen, representatives of the National Coalition of 100 Black Women, the National Coalition of 100 Black Men, the San Francisco African American Chamber of Commerce, and Black Women Organized for Political Action, among others.

Event host, the Black Action Alliance (BAA) was established to amplify the voices of the Bay Area’s Black community, whose perspectives have too often been overlooked in politics and public policy.

Loren Taylor, CEO of BAA, said it was important to bring the event to the Bayview in San Francisco and shared his organization’s mission.

“The Black Action Alliance (BAA) stands for practical, community-driven solutions that strengthen public safety, address homelessness, support small businesses, expand affordable housing, and ensure access to quality education—issues at the heart of the Black experience in the Bay Area,” said Taylor.

California’s primary election will take place on June 2 and the general election will take place on Nov. 3.