FDA Approves Female Sex Drive Pill, with Safety Restrictions

WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.

But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s.

The drug’s label will bear a boxed warning — the most serious type — alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.

“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.

Under a safety plan imposed by the FDA, doctors will only be able to prescribe Addyi after completing an online certification test demonstrating that they understand its side effects. Pharmacies will also have to be certified.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr. Janet Woodcock, director of the FDA’s drug center, in a statement.

Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lackluster effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.

On one side, Sprout and its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.

Beginning with the drug’s launch in mid-October, doctors who frequently see patients complaining about a loss of sexual appetite will have a new option.

“Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr. Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists. Iglesia said she has occasionally resorted to prescribing testosterone creams to boost women’s libido, a use not approved by the FDA.

The search for a pill to treat women’s sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological functions all proved ineffective.

Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.

Women and their doctors will have to decide whether the drug’s modest benefits warrant taking a psychiatric pill on a daily basis.

Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.

Opponents of the drug say it’s not worth the side effects, which include nausea, drowsiness, dizziness and fainting that can lead to serious injuries. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.

Tiefer and other critics said the FDA was pressured into approving the drug by a feminist-themed lobbying campaign funded by Sprout and other drugmakers.

“It’s just a mishmash of politics and science and sex and money,” Tiefer said.

The lobbying group, dubbed Even the Score, began publicizing the lack of drugs for female sexual dysfunction as a women’s rights issue last year.

“Women deserve equal treatment when it comes to sex,” the group states in an online petition to the FDA, which attracted more than 60,000 supporters. Women’s groups, including the National Organization for Women, signed on to the effort, though it was funded by Sprout and other companies working on female sex drugs.

At an FDA meeting in June, more than 30 members of the public called for the drug’s approval, frequently citing the Even the Score campaign. They vastly outnumbered speakers who spoke in opposition to the drug. At the meeting’s conclusion, the panel of FDA advisers voted 18-6 to recommend approving the drug, with safety restrictions.

Sprout declined to comment on how much it spent on the campaign.

For now, executives with the Raleigh, North Carolina-based company are setting modest expectations for Addyi, their first and only product. The company has no plans for TV advertising and will focus its 200 sales representatives on promoting the drug to medical specialists.

“We will be small,” CEO Cindy Whitehead said. “We will be specialty focused among the physicians who already have a familiarity with female sexual dysfunction.”

Women with insurance can expect to pay between $30 and $75 per month for Addyi, depending on the terms of their coverage.

The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.

Surveys estimate that 8 to 14 percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million U.S. women. Because so many factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders.

The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

By: CBS News 
June 4, 2015

WASHINGTON — Government health experts are backing an experimental drug intended to boost the female sex drive, but stress that it must carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting.

The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical’s daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks. The FDA often follows its panels’ recommendations, but is not required to. A final decision on whether to approve the drug is expected in August.

The positive recommendation is a major victory for a drug sometimes hailed as “female Viagra,” but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues. The FDA has twice rejected the drug since 2010.

Despite the comparisons to Viagra, flibanserin is not the same medication and works very differently in the body than drugs that treat erectile dysfunction in men.

“A drug like Viagra is actually relatively simple when compared to a drug that could treat decreased libido, when so many factors — medical, psychological, sleep, how your day was — can be playing a role,” said CBS News chief medical correspondent Dr. Jon LaPook.

The experts acknowledged that flibanserin’s effect is not very strong, but noted that there is a need for FDA-approved treatments to treat women’s sexual problems.

“These are very modest results,” said Dr. Julia Heiman of the Kinsey Institute at Indiana University. “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”

In general, women taking flibanserin reported between 0.5 and 1 additional sexually satisfying event per month than women taking placebo. They also scored higher on questionnaires measuring desire, while scoring lower on measures of stress. However, one in 5 women experienced an adverse effect while taking the drug, Dr. Adriane Fugh-Berman of Georgetown University told CBS News.

In a statement, Sprout Pharmaceuticals said it was pleased with the FDA advisory panel’s recommendation on the drug, which it hopes to market under the brand name ADDYI. The company says it will work with the FDA to develop appropriate safety guidelines for patients and doctors.


US regulators approve ‘female Viagra

Washington (AFP) – US regulators Tuesday approved the first “female Viagra,” a drug known as Addyi that works on the brain to boost younger women’s libido if they have lost interest in sex.

Made by North Carolina-based Sprout Pharmaceuticals, Addyi, also known as flibanserin, received the nod from the US Food and Drug Administration, on the condition that extra care is taken to ensure women do not take it with alcohol due to the risk of serious side effects.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research.

The FDA approved Addyi specifically for a condition known as “acquired, generalized hypoactive sexual desire disorder (HSDD),” or sudden and severe loss of libido.

“Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women,” the agency said.

The disorder can develop in women who previously were sexually active, causing distress and relationship problems, “and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.”

The drug must not be taken with alcohol, and will only be available at certified pharmacies because of the potentially serious interaction with alcohol, including risks such as fainting and severely low blood pressure.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” Woodcock added.

– Failed before –

In June, an advisory panel to the Food and Drug Administration urged regulators to approve flibanserin, after previously voting against it twice in years past.

The FDA is not required to follow the advice of the panel, but it often does.

Attempts to bring the drug to market failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.

According to documents on the FDA website, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.

“It has been a remarkable journey to get to this breakthrough moment. Today, we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” said Cindy Whitehead, chief executive officer of Sprout.

“We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

– Most commonly diagnosed disorder –

The drug is a non-hormonal agent that acts on neurotransmitters in the brain, and aims to treat HSDD among women who have not yet entered menopause.

Rebecca Zucconi, an assistant professor of medical sciences at the Frank H. Netter School of Medicine at Quinnipiac University, said the condition is the most commonly diagnosed sexual dysfunction in women.

“Until now, physicians have been limited to recommending education, counseling, psychotherapy and, in some cases, off-label usage of testosterone and estrogen therapy as treatment options for otherwise healthy women with HSDD,” Zucconi said.

Addyi can have significant side effects including nausea, dizziness and sleepiness.

Safety concerns include sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse.

Experts also raised questions about the increased risk of breast cancer seen in one of two studies on lab animals.

FDA Approves Controversial ‘Little Pink Pill’ But With Restrictions

The Food and Drug Administration has approved a pill that aims to increase a woman’s desire for sex — a controversial decision made only after an extended lobbying campaign by the drug’s makers.

But the agency’s imposed an unusual number of restrictions on who can prescribe the drug and how they can prescribe it — moves aimed at minimizing concerns over its side effects.

The pill’s called flibanserin and will be marketed under the brand name Addyi. The FDA is asking its maker, Sprout Pharmaceuticals, to specially train doctors and pharmacists who dispense it and to keep track of any problems with women taking the drug. Only trained physicians will be allowed to write prescriptions for the pill.

The FDA is also requiring a strong warning to women that they should never drink alcohol while taking the drug and stressing the risk that it can cause sudden fainting – a special danger for drivers.

The FDA had rejected the drug twice before. Sprout, which bought rights to the drug when pharma giant Boehringer Ingelheim dumped it, helped wage a public relations campaign called “Even the Score.” It claimed that while men have many different sexual dysfunction drugs to choose from, including Viagra and Cialis, women have none.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Critics said Addyi shouldn’t win approval because of its side effects and because its benefits were modest. But the FDA said there’s no other drug to help women with a severe lack of sexual desire called hypoactive sexual desire disorder.

Dr. Susan Wood, a former FDA official now at George Washington University, said she was disappointed by the approval.

“This is a product that is neither very effective nor particularly safe,” Wood told NBC News.

“It won’t benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women’s sexual health has to be treated in a very special way,” Wood said.

Wood and Dr. Philip Hanno, a urologist at the University of Pennsylvania’s school of medicine, both say the FDA was pressured into approving the drug. Hanno is one of the FDA advisers who voted against recommending approval of Addyi last June.

“I think the FDA was under a lot of pressure,” Hanno told NBC News. “This ‘Even the Score,’ the group which apparently was supported by the pharmaceutical company among others, was very influential and they certainly had a lot of people at the advisory committee meeting who made comments.”

 New drugs aim to increase female desire 3:56

The drug is far from being an aphrodisiac. “Hypoactive sexual desire disorder is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance,” FDA says.

“HSDD is acquired when it develops in a patient who previously had no problems with sexual desire.”

In other words, women like Katherine Campbell. Campbell, 31, thinks she could benefit from the drug.

“One day I had this great, awesome sex drive and a great relationship with my husband and the next day, I didn’t even think about it any more,” she said.

She and her husband Christopher, who live in Indianapolis, noticed the change after their first son was born. “I lost not only a very intimate part of my relationship with my husband, but also a lot of my confidence. My sexuality as a woman changed,” Campbell, who has campaigned for the drug’s approval, told NBC News.

Studies show that on average Addyi increased the number of so-called satisfying sexual events by half to one additional event per month over placebo.

 ‘Female Viagra’ Pill Gets FDA Approval 1:57

It doesn’t work like Viagra and other men’s erectile dysfunction drugs. They work by increasing blood flow all over the body, including to the genitals, helping improve a man’s physical ability to have sex. Flibanserin modifies serotonin, a message carrying chemical in the brain. It’s believed to act over time to increase a woman’s ability to become sexually aroused.

“If someone has low sexual desire because they hate their partner, sex hurts and their life is a mess … the pill is not going to help them,” said Dr. Lauren Streicher of Northwestern University.

“This is a huge advancement in women’s health because for the first time we have an FDA approved, non-hormonal option for women who have this very distressing lack of sexual desire,” Streicher said.

“And as a sexual health expert, as a gynecologist, as someone who takes care of women every single day … this is going to be a game changer for me because right now I have women that come into my office and have these issues and I just say, ‘I’m so sorry. There is nothing that I can do.'”

The company says it will aim to price Addyi to compare to the cost of Viagra. They anticipate it’ll probably be covered by health insurance companies with a co-pay of $30 to $75. Sprout says it should become available in October.

Flibanserin, ‘female Viagra,’ distracts from real causes of low libido: critics

Many sexual problems are related to relationship issues, stress and life events, experts argue

By Kazi Stastna, CBC News Posted: Aug 24, 2015 5:00 AM ET Last Updated: Aug 24, 2015 7:28 AM ET

Desire is complex, sex researchers say, and affected by many factors in a couple's life. Some experts are skeptical that the drug flibanserin, which is newly approved by the U.S. FDA and aims to boost women's libido, will truly make a difference to couple's sex lives.

Desire is complex, sex researchers say, and affected by many factors in a couple’s life. Some experts are skeptical that the drug flibanserin, which is newly approved by the U.S. FDA and aims to boost women’s libido, will truly make a difference to couple’s sex lives. (Christian Hartmann/Reuters)


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The U.S. approval of a pill to treat low libido in women has whipped up a whirlwind of debate and raised questions about whether the so-called female Viagra addresses the real reasons for lack of sexual desire.

The U.S. Food and Drug Administration last week approved flibanserin, to be sold under the name Addyi starting in October, for the treatment of hypoactive sexual desire disorder (HSDD) among premenopausal women — some two decades after Viagra was approved for the treatment of male erectile dysfunction.

Sprout Pharmaceuticals pitched flibanserin as a drug that would finally give women with sexual dysfunction similar treatment options to men and bused dozens of women to FDA hearings in Maryland to attest to its benefits and plead for its approval in what some saw as a heavy-handed and misleading public relations campaign.

The FDA gave flibanserin the OK after twice rejecting it and despite concerns about its risks and modest efficacy because it said women suffering distress from low libido have an “unmet medical need.” Days after it did, Canadian pharmaceutical company Valeant offered to buy Sprout for $1 billion US and said it will apply to get flibanserin approved in Canada and other countries.

Taking pill vs. talking it through

Although often likened to Viagra, flibanserin was created as an antidepressant and works on the brain while erectile dysfunction medications stimulate blood flow to the penis. It must be taken daily — unlike Viagra, which is taken up to four hours before sex.

Critics argue it’s an ineffectual pharmacological solution for a problem better treated with relationship counselling, sex therapy and behavioural changes.

“Their suffering is real, but the women who testified had a lot of different stories, and some of those stories were very good reasons for having low libido, including having six children, having a one-year-old, having had breast cancer treatment …,” says Adriane Fugh-Berman, associate professor of pharmacology and physiology at Georgetown University in Washington, D.C., and director of PharmedOut, a pharmaceutical marketing watchdog group.


A few days after the new sexual dysfunction drug from Sprout Pharmaceuticals was approved for sale in the U.S., Canadian pharmaceutical company Valeant offered to buy it for $1 billion US. (Allen G. Breed/Associated Press)

Fugh-Berman’s view is echoed by Cynthia Graham, a Canadian psychologist currently working as a professor of sexual and reproductive health at the University of Southampton and a research fellow at the Kinsey Institute at Indiana University.

“We know that a lot of sexual problems are related to relationship issues, stress, contextual issues. … For these, I don’t think medication is the answer,” she said.

Most people are “inhibited and tongue tied” when it comes to sex, says sex therapist Leonore Tiefer. She tries to help patients unravel the relationship and personal issues at the root of their sexual problems, but that kind of work is much messier than popping a pill, she says.

“In a society where it’s your fault if you don’t get sex right, and you have to have a lot of it and you have to do it right but nobody teaches you how … you’re looking for a way to excuse yourself from your problems, and biology offers that excuse,” said Tiefer, a clinical associate professor of psychiatry at New York University School of Medicine.

Desire, arousal intertwined

Tiefer, who campaigned against approval of flibanserin, felt most members of the expert committee advising the FDA were not familiar enough with the latest research on sexual dysfunction and too swayed by patients’ emotional testimony.

Scientific thinking about sexual desire has changed, and, in fact, HSDD no longer appears in the Diagnostic and Statistical Manual of Mental Disorders, widely used to diagnose patients but also to assess insurance claims.


Mistakenly dubbed the ‘female Viagra,’ the male drug that improves blood flow to address erectile dysfunction, flibanserin targets the brain. Some women on flibanserin reported a greater number of ‘satisfying sexual events’ and less distress about their low libido. (Mark Blinch/Reuters)

It’s been reclassified as female sexual interest/arousal disorder because scientists don’t view desire and arousal as separable any more, says Graham.

Absence of sexual thoughts or fantasies used to be a key part of diagnosing a desire disorder in women, but “there’s a lot of research now that suggests not all women even report fantasies,” she said. “Some fantasize a lot, and others say they don’t fantasize but they feel very sexually satisfied.”

Desire is also no longer thought of as “this spontaneous, horny thing that just comes out of nowhere, which is pretty much how HSDD views it,” Tiefer said.

‘Compelling testimony’ about pill’s impact

Tiefer and Graham fear flibanserin feeds into the unrealistic expectations people have about sex.

“The approval of this drug is going to encourage that idea that we should all always have the same level of sexual desire, that it should not really be affected by having kids, by stress, by fatigue, by relationship problems,” Graham said.

Clinical trial subjects who were on flibanserin reported having only an average of 0.5 to one more “satisfying sexual events” a month compared with the placebo group and a modest alleviation of distress and increase in desire. Eight to 13 per cent were “much improved” on at least one of the three measures.


The approval of flibanserin comes with strict restrictions on who can prescribe and dispense it. The drug packaging will carry a boxed warning highlighting potential side effects and drug interactions, and doctors and pharmacists will have to be specially certified before giving the drug to patients. (Gary Cameron/Reuters)

“Most committee members felt these effects were small,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health, and one of six committee members (out of 24) to vote against the drug. “On the other hand, we were hearing from individuals who provided compelling testimony that the product made an important difference in their lives.”

Even those who recommended approval of the drug expressed reservations, because of its modest benefits and serious side-effects, which include low blood pressure, drowsiness and fainting.

“[I] believe that it should be used by almost no one,” said Walid Gellad, associate professor of medicine at the University of Pittsburgh and co-director of the Center for Pharmaceutical Policy and Prescribing.

Gellad says he has no regrets about recommending approval of flibanserin but advises women to “try everything” before they use it.

How Viagra works

Viagra helps a man get and maintain an erection sufficient for sex by increasing blood flow to the penis. Like all medicines Viagra can cause side effects, however not everybody experiences them. In fact, less than 1% will have serious side effects.

Side Effects

Very common (occur in 1 in 10 people)

    •  Nausea/headache

Common (affect between 1 in 10 and 1 in 100 people)

    •  Stuffy nose
•  Indigestion
•  Dizziness
•  Changes in vision (blue tint or blurring)
•  Skin flushes on the face (redness)

Uncommon (affect between 1 in 100 and 1 in 1000 people)

    •  Tiredness
•  Muscular aches and chest pain
•  Dehydration
•  Numbing sensation or hypersensitivity to pain or touching
•  Vomiting
•  Noticing a ringing or other noise in the ears (tinnitus)
•  Heart palpitations and an increased heart rate
•  Sensation of spinning or vertigo
•  Skin rashes
•  Evidence of blood in urine or semen (or bleeding from your urethra)
•  Pain or discomfort within the eye – may include blurred or double vision, watery eyes, eyes appearing bloodshot, increased sensitivity, bleeding in the eye

Rare (affect between 1 in 1000 and 1 in 10,000 people)

    •  Lightheadedness leading to fainting or passing out
•  Problems hearing
•  Nosebleeds
•  Increased or decreased blood pressure
•  Stroke (cerebrovascular accident) or other heart related medical conditions

Frequency Unknown But Very Rare

    •  Prolonged erection, or persistent painful erection of the penis (priapism)
•  Unstable angina/irregular heart beats (arrhythmias)
•  Seizures or other epileptic reactions
•  Sudden death due to heart attack
•  Severe flaking of the surface layer of the skin (toxic epidermal necrolysis)
•  Extensive blistering of the skin (Stevens-Johnson syndrome)
•  Mini-stroke (transient ischaemic attack) or loss of blood supply to the brain

How to decrease the risk of Viagra side effects

  • Avoid alcohol – more than two units of alcohol can have effects not only on the time Viagra takes to kick in, but may also disrupt a person’s ability to gain an erection.
  • Avoid recreational drugs – Recreational drugs such as ‘Poppers’ and ‘Room Odourisers’ can contain Nitrates which may potentially cause a fatal interaction with Viagra. Many recreational drugs can cause dangerous interactions with Viagra, so please consult your doctor for more information.
  • Take a lower dose – By taking a lower dose than normal you may experience fewer side effects and still get the benefits of the treatment. Please consult your doctor (via your Patient Record or your local GP) if you are considering lowering your dosage.
  • Potentially take with food – It is generally recommended to take Viagra on an empty stomach, but to reduce side effects you can take it with food. However please bear in mind that this may also reduce the effectiveness as it delays absorption, so some trial and error may be required to find a balance that suits you.
  • Check the interaction of prescription medicines with Viagra – Due to Viagra’s effect on blood pressure and the cardiovascular system, certain medicines can react dangerously with Viagra. This includes alpha blockers, medicines for heart attacks or strokes, nitrate based medicines or medicines which treat liver or kidney failure.


Viagra is a reliable choice to treat erectile dysfunction, and while side effects may occur they are very unlikely for the vast majority of users. After extensive testing, Viagra has been established as safe for consumption, and millions of men feel that its benefits considerably outweigh the possible exposure to side effects. If you are at all in doubt about the side effects of Viagra, please consult your doctor immediately.

F.D.A. Approves Addyi, a Libido Pill for Women


The first prescription drug to enhance women’s sexual drive won regulatory approval on Tuesday, clinching a victory for a lobbying campaignthat had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women.

The drug — Addyi from Sprout Pharmaceuticals — is actually the first drug approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire.

Advocates who pressed for approval of Addyi, many of them part of a coalition called Even the Score, said that a drug to improve women’s sex lives was long overdue, given the many options available to men.

“This is the biggest breakthrough for women’s sexual health since the pill,” said Sally Greenberg, executive director of the National Consumers League.

But critics said the campaign behind Addyi had made a mockery of the system that regulates pharmaceuticals and had co-opted the women’s movement to pressure the F.D.A. into approving a drug that was at best minimally effective and could cause side effects like low blood pressure,fainting, nausea, dizziness and sleepiness.

In announcing the approval, Dr. Janet Woodcock, a senior F.D.A. official, said the agency was “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The F.D.A. decision on Tuesday was not a surprise since an advisory committee of outside experts had recommended by a vote of 18 to 6 in June that the drug be approved, albeit with precautions required to try to limit the risks and ensure that it was not overused.

Addyi’s label has a boxed warning — the strongest kind — saying the drug should not be used by those who drink alcohol, since that can increase the risk of severely low blood pressure and fainting. It is also not to be used with certain other drugs and by people with liver impairment.

The pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension. Women are advised to stop using the drug if they see no effect after eight weeks.

The big question now is how many people will use Addyi (pronounced ADD-ee), which is also known as flibanserin and has been called the “pinkViagra.”

According to one survey, about 10 percent of women suffer fromhypoactive sexual desire disorder. The F.D.A. said the drug was approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines.

Dr. Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwestern University, said she sensed great interest for a drug like Addyi among her patients. She said the drug’s availability would encourage many women to talk to doctors about their sexual problems for the first time.

“I think this is going to change the conversation that’s taking place in medical offices across the country,” she said, much as the 1998 approval of Viagra made it acceptable for men to talk about erectile dysfunction.

Leonore Tiefer, a sex therapist at the New York University School of Medicine and critic of the drug, predicted the restrictions on use would keep Addyi from becoming popular. “It’s going to be more trouble than it’s worth,” she said.

Cindy Whitehead, the chief executive of Sprout, declined to predict sales of Addyi, which she said would be available starting Oct. 17.

To allay concerns that the drug would be overused, Sprout has said it would not advertise on radio or television for 18 months after the drug’s approval. Ms. Whitehead said the company would focus its marketing on doctors, not consumers. She said Sprout planned to hire 200 sales representatives, enough to call on about 30,000 doctors, mainly obstetricians and gynecologists but also some psychiatrists and primary care physicians.

She said the exact price of Addyi had not been decided, but suggested it would be roughly equivalent on a monthly basis to erectile dysfunction pills. Those pills are generally taken when needed, while Addyi is supposed to be taken every night before bedtime. That makes a direct comparison difficult. But 10 Viagra tablets, a possible monthly allotment, cost about $400.

It is not clear if insurance companies will pay for Addyi.

Ms. Whitehead said that she expected many would, with a co-payment of about $30 to $75 a month. Sprout will assist patients with co-payments, she said.

Some doctors might use the drug beyond the uses in the label, which doctors are allowed to do.

Dr. Streicher said that although the drug was approved for premenopausal women only, she “absolutely” would prescribe it for postmenopausal women as well.

Dr. Irwin Goldstein, a sex-medicine doctor in San Diego who has been a consultant to Sprout, said he would not necessarily withhold the drug from casual drinkers. Some women might find the risk of side effects acceptable if their relationships are in jeopardy because of a lack of desire, he said. “That’s a risk, too.”

Dr. Goldstein said he would also not rule out prescribing the drug off-label to men.

Ms. Whitehead said there was interest in learning whether the drug would work for men, but Sprout’s priorities would be to get it approved next for postmenopausal women and in foreign markets.

Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin.

There are disagreements among researchers as to what constitutes normal sexual desire in women. And there have been difficulties bringing to market a drug that would treat low desire.

Procter & Gamble failed to win approval for a testosterone skin patch for women about a decade ago. The F.D.A. rejected Addyi twice, in 2010 and 2013, citing marginal effectiveness and the side effects.

In one trial, for instance, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month, compared with 3.7 for women getting a placebo and 2.7 before the study began. The drug did not increase desire more than a placebo when measured by a daily diary, but did do so modestly when measured by a monthly questionnaire.

After the first rejection, Boehringer Ingelheim abandoned the drug. Ms. Whitehead and her husband, Robert, were at the time running a company that sold a testosterone product for men. The Whiteheads sold that business and formed Sprout to acquire flibanserin. Based in Raleigh, N.C., Sprout, a privately held company, had raised about $100 million, Ms. Whitehead said.

After the second rejection, various women’s and health groups formed Even the Score.

Sprout is paying at least part of the expenses for the coalition, whose members include the National Council of Women’s Organizations, the Black Women’s Health Imperative and the Association of Reproductive Health Professionals.

Even after the favorable advisory committee vote, critics of the drug sent letters to the F.D.A. urging it to reject Addyi. The agency usually follows the advice of its committees, but does not have to.

One letter, written by Dr. Tiefer of N.Y.U. and signed by about 100 others, said it was “absurd” to expect that young women taking Addyi would refrain from drinking alcohol. Another, by the PharmedOut project at Georgetown University Medical Center, which also had more than 100 signatures, said that the “unprecedented and unwarranted manufacturer-funded public relations campaign” may have confused the advisory committee members. A third letter, from sex researchers in the Netherlands and Belgium, said the drug was based on the mistaken notion that lack of spontaneous sexual desire, absent stimuli, was abnormal.

Even the Score is planning to stay in business, hoping that the approval of Addyi will spur other companies to develop drugs for women’s sexual health.

“It’s never been about one treatment,” said Ms. Greenberg of the National Consumers League, which received a contribution from Sprout and which formally joined Even the Score this month.

“For us to fold up our tent would be premature.”

Attention, Viagra Users of Columbus: Don’t Drink the Water


One day last August, residents in Toledo, Ohio, received a stark warning from city officials: Don’t drink your tap water, don’t wash the dishes in it, and don’t bathe your kids in it. This year, it’s the people of Columbus, 150 miles to the south, who received a jolt of bad news: In a large swath of the city and its suburbs, pregnant women and babies younger than six months of age have been advised to avoid the tap. In a warning well designed to titillate headline writers, another group landed on the don’t-drink-the-water list: Viagra users.

Consumption of nitrates has been linked to elevated rates of birth defectsas well as cancers of the ovaries andthyroid.

The advisory “will remain in effect until further notice,” the City of Columbus website states. The Columbus Dispatch reported that it could “last weeks.”

What gives? Toledo and Columbus are surrounded by industrial-scale corn, soybean, and hog farms, and in both cases, runoff from these operations fouled the water supply. In Toledo, the culprit was phosphorus finding its way from farm fields into Lake Erie, from which the city draws its water. Excessively high phosphorus levels fed a massive algae bloom, from which toxins seeped into the municipal water supply.


In Columbus, the problem is nitrate, from nitrogen fertilizer that leaches out of farm fields and into streams and rivers. Nitrates also concentrate in hog manure, which is also applied to farm fields and is prone to leaching. Nitrates in the water emerging from one of the city’s main water-treatment facilities, called Dublin Road, have exceeded the federal limit of 10 parts per million.

That’s bad, because nitrates are linked to a range of health problems at low exposure levels: They impede the blood’s ability to carry oxygen—a characteristic that’s particularly threatening to infants. They’ve also been linked to elevated rates of birth defects as well as cancers of the ovaries and thyroid. As for Viagra users, they should avoid the water because the drug interacts with nitrates in a way that can cause a dangerous drop in blood pressure.

On its website, the City of Columbus bluntly states the cause of the nitrate spike: “Elevated nitrate levels are primarily a result of fertilizer and agricultural runoff within the 1,000 square mile Scioto River watershed—80% of which is agricultural.”

The water-treatment plant in question currently lacks the ability to filter out nitrates. The city is spending $35 million on an ion-exchange treatment facility that, “when completed in 2017, will allow the plant to more effectively treat nitrate events such as this one,” its website states. Nitrate advisories like the current one have been common over the years, reports the Dispatch.

Nitrate-laced water is a problem throughout the Corn Belt, those upper Midwest states with high concentrations of ferilizer-intensive corn farming and large-scale hog-production facilities. A 2008 survey found that about half of Iowa’s private wells had measurable levels of nitrate, and in 12 percent the chemical turned up above the Environmental Protection Agency’s limit. And in Des Moines, the city’s water department is suing upstream farm-drainage districts, demanding that they be regulated under the Clean Water Act. To protect its residents from over-the-limit nitrate levels, Des Moines Water Works has had to run its nitrate-removal facility for a record 111 days this year, at a cost of about $7,000 per day. The filtration system dates to 1991, Des Moines Water Works claims, and will soon need to be replaced, which will result in a bill to rate payers as high as $183 million.

Meanwhile, the bulk of nitrates exiting the Corn Belt’s farms wind up in the Gulf of Mexico, where they feed a vast annual algae bloom that creates a Connecticut-sized oceanic dead zone.

The cases of Toledo, Columbus, Des Moines, and the Gulf share a theme: They represent major costs and liabilities of industrial-scale agriculture that take place off the books of the benefiting companies and are literally flowing downstream.