Posts tagged with "FDA"

Cuomo: Millions and millions of tests needed before U.S. economy can be rebooted

April 13, 2020

New York Governor Andrew Cuomo said on April 10 that millions of COVID-19 tests must be administered nationwide, if the country’s economy is going to reopen safely and effectively, according to a report by The Hill.

“This is going to be a horrendous transformational period for us,” Cuomo said in an appearance on MSNBC‘s Morning Joe.

“I don’t think we ever get back to normal. I think this is one of the new normals now in public health,” he said.

The governor added that just how smoothly American society and its economy will be able to reopen will directly correspond to what the steps the government does or does not take.

“This is such an important period for government and the political discussion,” Cuomo said. “Nothing is pre-charted here. It’s all a function of what we do.”

He added: “How good are we at getting this testing up? Are we better than we’ve been in the past? Is it going to take us months to come to scale on rapid testing? That’s the only way to get people back to work. You have to have millions and millions of tests, frankly, better and faster than we’ve done to date.”

This isn’t the first time that Cuomo has signaled that widespread testing to see who has had the virus is essential to America’s ability to get its people back to work, The Hill said.

Cuomo has said that New York State has developed a test that sees whether a person has developed antibodies to fight COVID-19. It has been well-documented that not everyone who contracted the virus will show outward symptoms consistent with the disease.

“We cannot restart life as we knew it without testing,” he tweeted earlier this week.

But Cuomo’s stance on testing differs from President Trump’s opinion on the matterThe Hill noted. In his daily coronavirus press briefing Thursday, Trump punted when asked about the need for widespread testing—saying that it would be nice but not required.

“We want to have it and we’re going to see if we have it. Do you need it? No. Is it a nice thing to do? Yes,” Trump said. “We’re talking about 325 million people. And that’s not going to happen, as you can imagine, and it would never happen with anyone else either.” 

Trump has expressed optimism that the country could start to ease social distancing recommendations by early May. The White House’s social distancing guidelines run through the end of April.

Cuomo isn’t alone in his call for comprehensive testing, though.

“In a setting where there will still be spread and we’ll still be slowly exiting the epidemic; we need capacity to test several million people a week (and probably more) to get broad enough coverage in community to detect outbreaks early and make case containment strategies work,” Scott Gottlieb, Trump’s former Food and Drug Administration commissioner, tweeted Thursday.

According to the COVID Tracking Project, the United States has tested about 960,000 people in the past week.

Research contact: @thehill

A glimmer of hope: New vaccine against COVID-19, called PittCoVacc, shows promise

April 6, 2020

It won’t help today’s patients (unless they are rats or mice); but, on April 2, University of Pittsburgh School of Medicine scientists announced in a press release that they had produced a potential vaccine against SARS-CoV-2— the new coronavirus causing the COVID-19 pandemic.

Through an expedited testing process, the vaccine, called the PittCoVacc, could be available for use in a little over a year.

When tested in mice, the vaccine—which is delivered through a fingertip-sized patch, not an injection—produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus. Indeed, PittCoVacc generated a surge of antibodies against SARS-CoV-2 within two weeks of the microneedle prick.

The researchers were able to act quickly to develop the vaccine because they already had laid the groundwork during earlier coronavirus epidemics: “We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus,” said co-senior author Andrea Gambotto, M.D., associate professor of Surgery at the Pitt School of Medicine. “That’s why it’s important to fund vaccine research. You never know where the next pandemic will come from.”

“Our ability to rapidly develop this vaccine was a result of scientists with expertise in diverse areas of research working together with a common goal,” said co-senior author Louis Falo, M.D., Ph.D., professor and chair of Dermatology at Pitt’s School of Medicine and UPMC.

Compared to the experimental mRNA vaccine candidate that just entered clinical trials, the vaccine described in this paper (PittCoVacc, short for Pittsburgh Coronavirus Vaccine) follows a more established approach, using lab-made pieces of viral protein to build immunity. It’s the same way the current flu shots work.

The researchers also used a novel approach to deliver the drug, called a microneedle array, to increase potency. This array is a fingertip-sized patch of 400 tiny needles that delivers the spike protein pieces into the skin, where the immune reaction is strongest. The patch goes on like a Band-Aid and then the needles—which are made entirely of sugar and the protein pieces—simply dissolve into the skin.

“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” Falo said. “And it’s actually pretty painless—it feels kind of like Velcro.”

The system also is highly scalable. The protein pieces are manufactured by a “cell factory”—layers upon layers of cultured cells engineered to express the SARS-CoV-2 spike protein—that can be stacked further to multiply yield.

Purifying the protein also can be done at industrial scale. Mass-producing the microneedle array involves spinning down the protein-sugar mixture into a mold using a centrifuge. Once manufactured, the vaccine can sit at room temperature until it’s needed, eliminating the need for refrigeration during transport or storage.

“For most vaccines, you don’t need to address scalability to begin with,” Gambotto said. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”

Importantly, the SARS-CoV-2 microneedle vaccine maintains its potency even after being thoroughly sterilized with gamma radiation — a key step toward making a product that’s suitable for use in humans.

The authors are now in the process of applying for an investigational new drug approval from the U.S. Food and Drug Administration in anticipation of starting a phase I human clinical trial within the next few months.

“Testing in patients would typically require at least a year and probably longer,” Falo said. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.”

Among the additional authors on the study are Eun Kim, Geza Erdos, Ph.D., Shaohua Huang, Thomas Kenniston, Stephen Balmert, Ph.D., Cara Donahue Carey, Michael Epperly, Ph.D., William Klimstra, Ph.D., and Emrullah Korkmaz, Ph.D., all of Pitt; and Bart Haagmans, of Erasmus Medical Center.

Research contact: @UPMCNews

Change of heart: Vets say dogs’ cardiac problems are linked to grain-free food

January 1, 2020

Debbie Turner remembers the shock when a veterinary specialist said her beloved dog, Kanga Lu, had severe heart damage. NBC News reports. For weeks, Kanga had been experiencing odd symptoms— including fatigue, breathing problems and what her local vet assumed were seizures. But now Turner was being told that the Maltese-Chihuahua mix was in late-stage heart failure. The seizures, it turned out, had been fainting spells.

“So I’m sitting with what I thought was a healthy six-year-old dog that was having minor seizures, and now I find out she might only have three months to live,” said Turner, 66, of Orlando, Florida.

She was heartsick and it turned out that something she had done out of love for her pet–buying what she believed to be the very best commercially available food—was doing the damage.

The first question the specialist had asked Turner when she brought in Kanga—whose blood pressure had skyrocketed—was, “Do you feed her grain-free dog food?” The answer was yes.

NBC News is now reporting that Turner is one of a growing list of pet owners whose healthy sounding dog food may have somehow led to a serious heart problem in their pets called dilated cardiomyopathy.

The Food and Drug Administration last year announced a possible link between the condition, which can cause heart failure; and grain-free pet foods, which replace grains with ingredients like peas, lentils ,or potatoes.

By April, the agency said that it had received 524 reports of 560 dogs and 14 cats diagnosed with DCM that appeared to be related to diet. In June, the FDA took the unusual step of listing the 16 brands of dog foodamong them, such popular brands as Blue Buffalo, Natural Balance, NutriSource, Nutro, and Rachael Ray Nutrishnder investigation.

It’s still not known exactly how certain pet foods may be damaging pet hearts, but researchers have found some clues. Possible culprits include deficiencies in certain compounds necessary for heart health, as well as diets with exotic ingredients.

In dogs and cats developing DCM, the “walls of the heart become thin, and its ability to pump blood decreases,” Dr. Bruce Kornreich, a veterinary cardiologist and director of the feline health center at the Veterinary College of Cornell told NBC News. “If this continues, your pet can end up with chronic heart failure.”

DCM is a known genetic issue for certain large breeds of dogs, including great Danes, German shepherds, and Doberman pincers. But when the FDA and veterinarians around the country started to see dogs of all sizes developing this kind of heart damage several years ago, they grew alarmed.

The number of cases of DCM are likely to rise, experts say.

“We continue to see dogs coming into our hospital affected by this problem,” Dr. Lisa Freeman, a veterinary nutritionist and professor at the Cummings School of Veterinary Medicine at Tufts University, told the network news outlet. “It’s not going away.”

Unfortunately, Freeman said, the solution is probably not going to be a simple one, and the suspect foods are not just those described as “grain free.” She and others are now investigating a broader class of foods, dubbed “BEG” foods: ones that are made by boutique companies, contain exotic ingredients, or are grain-free.

The FDA echoes Freeman’s concerns about a complex solution. “At this time, it is not clear what it is about some diets that may be connected to DCM in dogs, but FDA believes it may be multi-factorial,” said Monique Richards, an FDA spokesperson. “There are multiple possible causes of DCM.”

Research contact: @NBCNews

2020 hindsight: LASIK eye surgery should be taken off market, former FDA adviser says

November 15, 2019

Don’t turn a blind eye to the risks involved in LASIK eye surgery, an expert is warning, according to CBS News.

Laser vision correction has been popular for more than 20 years, with an estimated 20 million Americans undergoing the procedure to correct nearsightedness and improve distance vision.

According to an FDA patient survey, more than 95% of patients have been satisfied with their vision after surgery. But some patients say the surgery has ruined their eyesight. Among the complaints: “relentless eye pain,” dizziness, and detached retinas.

“Essentially we ignored the data on vision distortions that persisted for years,” said Morris Waxler— a retired FDA adviser who is now president of Waxler Regulatory Consulting. He voted to approve LASIK devices, but he now says voted to approve LASIK, but he now says that vote was a mistake.

“I re-examined the documentation … and I said, ‘Wow this is not good,'” Waxler told CBS News.

Waxler said his own analysis of industry data shows complication rates between 10%  and 30%. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. Three years later, the agency denied that request and now tells CBS News it “has not found any new safety concerns associated with LASIK devices.” 

Waxler said he thinks LASIK should “absolutely” be taken off the market. “There’s nothing wrong with a person’s eyes who goes to get Lasik,” he said. “They have healthy eyes. They could go and get a pair of glasses.”

Patient Abraham Rutner agrees, alleging that  LASIK surgery damaged his vision and nearly ruined his life. “It’s a devastation that I can’t even explain,” Rutner told CBS News medical contributor Dr. Tara Narula.

“Things would appear double. Around the lights were like having starbursts,” he added.

After months of not being able to drive or do his job, the Brooklyn electrician finally found help in Miami where optometrist Edward Boshnick fitted him with special contact lenses.

“His cornea is very distorted as a result of his LASIK surgery,” Boshnick told CBS.

Boshnick estimates he’s treated thousands of patients with LASIK complications.

Paula Cofer had surgery 19 years ago, “and from day one my vision was an absolute train wreck and it still is today,” she said.

She started a LASIK complications support group on Facebook and quickly found she was not alone. “You really have to understand you’re risking your only pair of eyes,” Cofer said.

Doctors who perform LASIK surgery said risks can be minimized with pre-surgical screening.

“The most important thing is knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur said.

Rutner now believes he was never a good candidate.

Here are FDA’s advisory on risks and how to find the right doctor for the procedure.

Research contact: @CBSNews

Study calculates links between prescription medications and risk for suicide

November 6, 2019

There’s a saying that what doesn’t kill us makes us stronger—but that shouldn’t be true of the FDA-approved drugs prescribed to us by our doctors.

Nevertheless, a review by the Center for Health Statistics at the University of Chicago of 922 medications that had been prescribed to nearly 150 million Americans over an 11-year period recently found that just 10 of these drugs were associated with an increased rate of suicide attempts, the university reported on November 5 in a press release.

Conversely, 44 drugs were linked to a decrease in suicide attempts, including many that carry a “black box” label from the FDA warning of their association with suicidal behavior.

The study findings, published in the Harvard Data Science Review, identifiy several drugs with the potential to prevent suicide attempts that are not currently used for that purpose, including folic acid, a simple vitamin often prescribed to pregnant women.

“There’s an antihistamine that’s associated with decreases in suicide. There’s a Parkinson’s drug associated with decreases,” said Robert Gibbons, PhD, the director of the center and lead author of the study. “If those test out in clinical trials to be real effects, we could be using more of these drugs to treat suicidal people.”

Suicide is now the tenth leading cause of death in the United States, according to the National Institute of Mental Health. Most suicides occur in patients with a psychiatric disorder, such as depression. However, common antidepressant medications such as fluoxetine (Prozac) carry the FDA’s black box warnin— which has led to decreased use of these medications, despite the benefits they might provide.

For the new study, Gibbons and his team developed a statistical tool to measure the links between drugs and suicide attempts. They analyzed data on 922 drugs with more than 3,000 prescriptions in a database of medical claims from 2003 to 2014. The data contained records of 146 million unique patients from more than 100 health insurers in the United States. For each person taking each drug, they counted suicide attempts in the three months prior to filling the prescription and the three months after taking the drug. This approach allowed them to evaluate each drug individually within a single person and see its effect on suicide attempts.

“It’s actually a very simple model that answers the question, ‘Does a suicide attempt occur more frequently after taking the drug than before?'” Gibbons said.=

That analysis found 10 drugs that showed a statistically significant increase in suicide attempts-among them, the opioid painkiller hydrocodone bitartrate and acetaminophen (Vicodin); anti-anxiety drugs alprazolam (Xanax) and diazepam (Valium); and prednisone, a corticosteroid.

 A total of 44 drugs showed a decrease in suicide risk, including a large group of antidepressants with black box warnings like fluoxetine and escitalopram (Lexapro), gabapentin (Neurontin), an anti-convulsant used to treat seizures, and, interestingly, the vitamin folic acid.

Gibbons said the statistical model can be used to calculate the risk of any adverse events that happen before and after taking a medication. The Veterans Administration already has expressed interest in using the tool, and Gibbons hopes other large hospital systems and local health agencies will adopt it to help decide which drugs to prescribe, especially for patients at risk of suicide.

“What we’ve done is come up with an alternative approach to drug safety surveillance that could be used by any agency, country or formulary,” he said. ”

Research contact: @UChicago

FDA proposes that manufacturers and doctors warn women about risks of breast implants

October 24, 2019

Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration (FDA) said on October 23, according to a report by The New York Times.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, the Times said, and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery.

The measures are not mandated by the agency; they are proposals now open to public comment and industry input.

Millions of women have implants—silicone sacks filled with either saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomies for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure, the news outlet notes: Some 313,000 augmentations were performed in 2018, a 4% increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

In turn, thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue, a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases. Implants have also been linked to a rare cancer of the immune system called anaplastic large cell lymphoma, which can be fatal. Most of the cancer cases developed in women with textured implants.

The agency warned two implant manufacturers earlier this year that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

At an advisory panel meeting in March, women with breast implants testified about their illnesses and implored the agency to take action. More than 70,000 women signed a petition demanding the F.D.A. to require the checklist.

Advocates urged agency officials to require the long-term safety studies that were promised and to start patient registries to track outcomes. Some women asked the F.D.A. to ban breast implants altogether.

According to the Times report, agency officials said they had “heard loud and clear” that there was “a distinct opportunity to do more to protect women who are considering implants.”

The F.D.A. also wants implant manufacturers to list the ingredients in implants, in an easy-to-understand format for patients, so that women know about chemicals and heavy metals in the products.

The agency also is proposing new screening recommendations for women who already have silicone gel implants, saying they should undergo imaging scans to look for ruptures beginning five to six years after the surgery and every two years after that, the Times reported.

At the request of the F.D.A., Allergan in July recalled textured breast implants linked to the unusual cancer.

 Research contact: @nytimes

Biogen’s Alzheimer’s treatment could be ‘the biggest drug ever’

October 23, 2019

Shares of Biogen soared 30% on Tuesday, October 22, CNBC reported, after the drugmaker announced it was seeking regulatory approval for the Alzheimer’s drug, Aducanumab, which it had announced it was at least temporarily giving up on earlier this year.

“It would be the biggest drug ever,” said CNBC’s Jim Cramer on “Squawk on the Street.”

The announcement  from Cambridge, Massachusetts-based Biogen and Tokyo-based Eisai—a leading global research and development-based pharmaceutical company—came after a consultation with the U.S. Food and Drug Administration (FDA) on plans to pursue a regulatory approval for the drug after a Phase 3 EMERGE Study met its primary endpoint—showing a significant reduction in clinical decline.

According to the joint research teams, ‘Patients who received Aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. Patients also experienced benefits on activities of daily living—including conducting personal finances; performing household chores, such as cleaning, shopping, and doing laundry; and independently traveling out of the home.

They noted, “If approved, Aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.”

Indeed, Biogen erased its entire 25% year-to-date decline after the announcement became public. The company plans to file for approval with the FDA in early 2020.

“The whole concept of senior living will change,” commented CNBC’s Cramer. “You know whose going to take this drug?” asked Cramer. “Everyone.”

Research contact: @CNBC

Neutrogena recalls Light Therapy Acne Masks, due to risk of eye injuries

July 22, 2019

Many consumers have “seen the light” when it comes to over-the counter acne LED-light therapy masks—and that’s not necessarily a good thing. In fact, earlier this month, Neutrogena issued a recall of its masks, according to The New York Times;  citing a “theoretical risk of eye injury” to a subset of users who have underlying eye conditions or are taking medicine that makes them sensitive to light.

The Times reported that Neutrogena said in a statement that its July 5 recall followed “reports of mild, transient visual adverse events, combined with a growing scientific discussion around the safety of blue light.”

A spokesperson told the news outlet that the “adverse events” had been caused by the Neutrogena masks; although she did not specify how many such events had taken place. She also said that no particular study or expert had informed the company’s decision to recall the masks.

But that is not the only brand that uses visible blue and red lights to treat facial acne. And it may not be the only mask that is causing problems—problems which the Australian Department of Health recently said could cause retinal damage or impair peripheral vision after repeated therapy with the lights.

Among the most popular among these devices are the Lacomri 7 Color LED Light Therapy Acne Mask, Convinsimo Light Therapy Acne Face Treatment, Neutrogena Light Therapy Acne Mask, and Pulsaderm Acne Clearing Mask.

They all use the same treatment technology, explains the American Academy of Dermatology.

And that also may mean that they might share another problem: Such devices kill facial bacteria that could turn into pimples; they are not effective against existing blackhead, whiteheads, acne cysts, or nodules, the academy explains.

Indeed, says the academy, “Most people see clearing, but not 100%”—and “results vary from person to person.”

News of the recalls in the United States and in Australia was for the most part missed by consumers . A spokesperson for the U.S. Food and Drug Administration told the Times that the agency was “aware of the recall” and was looking into it.

The mask was released by Neutrogena in October 2016. Actress Lena Dunham endorsed it on Instagram and said her post was not an advertisement. The product was awarded Best of Beauty in 2017 by Allure magazine..)

Dr. Rachel Nazarian, with Schweiger Dermatology Group in New York City, told the news outlet that only recently had concerns about blue light cropped up, and that they mostly referred to people who had baseline medical conditions that caused their retinas to be more sensitive to light.

But she said that Neutrogena’s mask did not offer enough eye protection. While she planned to continue to use LED treatments in her own practice, she said she used much stronger eyewear than was provided by the company.

“It shouldn’t be used in such a cavalier form,” Dr. Nazarian said. “If you’re using the right eyewear protection, you should be fine.”

Research contact: @nytimes

Last licks: Woman caught on social media licking store ice cream and putting it back faces years in jail

July 8, 2019

A woman who licked more than her lips at a Walmart store may find herself in the “cooler” soon. The “mystery shopper” (who has not yet been identified by authorities) went viral on social media recently for licking a tub of ice cream and returning it to the frozen food display.

Now police say that, when they find her, she faces up to 20 years in prison for the prank, according to a July 4 report by NBC News.

The footage of the escapade—which already has been viewed more than 11 million times— shows the so-far unnamed woman opening a container, running her tongue across the ice cream; then laughing as she places the violated dessert back in the freezer, in a branch of Walmart in the city of Lufkin, eastern Texas.

She could face a second-degree felony charge of tampering with a consumer product, the Lufkin, Texas, Police Department said in an email statement to NBC News. The charge comes with a two- to 20-year prison term and up to $10,000 in fines, according to Texas state penal code.

Police also want to speak to the man she was with, who is thought to have filmed the incident and can be heard encouraging the woman to “Lick it, lick it.”

According to NBC, investigators also are in discussions with the FDA and additional federal charges could be made.

“Our detectives are working to verify the identity of the female suspect before a warrant is issued for her arrest on a charge of second-degree felony tampering with a consumer product,” a police spokesperson said.

“As that portion of the investigation continues, detectives are focusing on identifying the male (in the green shirt) behind the camera seen in images of the two entering the store together.”

Blue Bell Creameries, the local manufacturer of the ice cream brand the woman licked, has called the incident a “malicious act of food tampering.”

All tubs containing the mix of creamy vanilla ice cream with swirls of chocolate fudge and dark-chocolate-covered roasted peanuts have been removed from the store’s shelves as a precaution, the company said. The specific carton believed to be compromised was found among the lot.

In an earlier statement, the company explained that its cartons are frozen upside down in production, which creates a natural, tight seal by freezing the lid to the tub, meaning consumers would notice if any tampering occurred upon opening a fresh tub.

Research contact: @NBCNews

FDA approves another ‘Viagra for women’

July 3, 2019

Late in June, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide)—a libido-booster for premenopausal women.

The drug is injectable, and the manufacturer—Waltham, Massachusetts-based AMAG Pharmaceuticals—says it should be self-administered by placing the needle under the skin of the adbdomen or thigh and pushing the plunger, at least 45 minutes before sexual activity.

But, the pharmaceutical company also advises that patients, themselves, should decide on the “optimal time” ahead of intercourse for the injection because the drug has side effects that can ruin the mood—among them, nausea and vomiting, flushing, injection site reactions, and headaches.

About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection; and 13% needed medications for the treatment of nausea. About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts—which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.

How does it work? Vyleesi activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown.

Still, the FDA says that this drug represents an advance in treating low sexual desire, for women and their partners affected by this problem.

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products.

The approval of Vyleesi by the FDA follows the agency’s 2015 approval of Addyi, which also was designed to boost libido, but which no one really wanted. (Its sales are currently “tepid,” according to a recent report by The New York Times. Addyi also caused fainting when combined with alcohol.)

Research contact: @US_FDA