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FDA Recalls Sexual Enhancement Products With Undeclared Viagra, Cialis
- The FDA announced a recall of sexual enhancement products containing undeclared prescription drugs like Viagra and Cialis due to health and safety risks.
- The March 16 recall was issued by the products’ distributor Pyramid Wholesale following an investigation by the California Department of Health.
- CDPH identified 11 sexual enhancement supplement products containing prescription drugs that were not disclosed on product labeling and issued a safety warning.
- No adverse events have been reported, but Pyramid Wholesale advised consumers to discontinue use.
The Food and Drug Administration (FDA) announced a recall of sexual enhancement supplement products containing undeclared prescription drugs like Viagra.
Pyramid Wholesale issued the March 16 recall after an investigation by the California Department of Public Health (CDPH) determined its sexual enhancement products were unsafe.
CDPH identified multiple dietary supplements containing undeclared prescription drugs, including Sildenafil (Viagra) and Tadalafil (Cialis), which could have adverse effects like misuse and interactions with other medications, and posted a consumer warning on its website, a CDPH representative told Healthline.
The recall includes 11 different products — “Spanish Fly” and “Samurai-X,” among others — that varied in dosage, with some marketed specifically for female or male sexual enhancement.
The products were sold in bulk to retailers and other distributors in California and surrounding areas. The full list of products can be found on the FDA’s website.
No adverse events have been reported, but Pyramid Wholesale advised consumers to stop using the products immediately. “We deeply regret any worry or inconvenience this recall may have caused,” the company said in a statement.
Health risks of undeclared drug ingredients
All sexual enhancement products involved in the Pyramid Wholesale recall contained undeclared prescription drugs, CDPH found.
“Undeclared prescription drugs refer to medications or pharmaceutical compounds that are present in a product without being listed on the product label or disclosed to consumers,” Dr. Ashley Tapscott, board certified urologist and advisor to Marius Pharmaceuticals in North Carolina, told Healthline.
“These drugs are often included in dietary supplements, herbal products, or other health supplements without proper regulation or oversight.”
When drugs are not listed in ingredient statements it means the products have not undergone rigorous testing, which may raise the risk of serious adverse events, such as:
- misuse and overuse
- drug interactions
- allergic reactions
- contraindications with health conditions
OTC sexual supplements are an easy, but not always safe choice
Consumers may opt for over-the-counter (OTC) sexual enhancement products over visiting an OB-GYN, urologist, or therapist for any number of reasons, convenience being a likely factor.
For some individuals, sexual health discussions with healthcare professionals may be uncomfortable or stigmatizing, and the anonymity of OTC products could seem more appealing.
And for many people, especially those without insurance, medical treatment may come at a higher cost compared to trying OTC supplements.
“These supplements are easily accessible without the need for a doctor’s visit or prescription, offering convenience for individuals seeking a quick solution to their sexual health concerns,” Tapscott said.
“Lack of awareness or education about the risks associated with unregulated supplements may lead individuals to believe they are safe and effective based on marketing claims or anecdotal evidence.”
Treatments for sexual dysfunction, erectile dysfunction
There is limited scientific evidence to support the health claims of many sexual enhancement supplements because, as with other dietary supplements, they are largely unregulated by the FDA.
As such, supplement products claiming to aid sexual dysfunction or improve erectile dysfunction (ED) often lack oversight or consultation with medical professionals.
“Unregulated supplements may claim to enhance testosterone levels through various ingredients. However, the actual effects can vary widely, and the safety of these supplements in regulating testosterone is often questionable,” Tapscott said.
Most experts recommend addressing health concerns with a medical professional who can develop an appropriate treatment plan and ensure patients receive the right medication.
Tapscott noted for low testosterone specifically, testosterone replacement therapy (TRT), which is FDA-approved, can promote sexual enhancement and also help treat erectile dysfunction in males with low testosterone.
Of course, Viagra and Cialis, which when used as prescribed and directed, can be effective, science-backed treatments for ED.
“It’s very important to find legitimate sources for all medications — even compounding pharmacies can’t always be trusted,” Tapscott said.
“Make sure the drugs you are taking are FDA-approved. If you have any questions or concerns about medications or prescription drugs, it’s important to consult with a qualified healthcare professional to ensure your health and safety.”
Takeaway
The FDA announced a recall of 11 sexual enhancement dietary supplement products distributed by Pyramid Wholesale.
The recall was prompted by a California Department of Public Health investigation, which identified prescription drugs like Viagra and Cialis that were not included in the product labeling.
No adverse events were reported, but consumers should discontinue using these products immediately.
Fluctuations in BMI May Increase Risk of Heart Disease
- Researchers people with body mass index measurements that fluctuate between high and low have higher risks of serious cardiovascular issues.
- Experts say the variations in body mass index can put additional strain on the heart and other organs.
- They add that regaining weight also tends to produce abdominal fat.
- They say that regular exercise and a healthy diet are two ways to maintain body weight at a healthy level.
Having a high body mass index (BMI) may be linked to a wide range of health issues, which can ultimately result in serious cardiovascular conditions.
According to a new study, highly variable BMI was associated with adverse cardiovascular events. Highly variable BMI is repeated fluctuations in weight.
The findings were published in JAMA Network Open: Cardiology.
Researchers analyzed data gathered from the Million Veteran Program between 2011 and 2018 and participants in the UK Biobank enrolled between 2006 and 2010. The follow-up was an average of nearly 4 years.
Researchers reported that increased BMI fluctuation was associated with adverse cardiovascular events regardless of common cardiovascular disease risk factors and genetic risk.
They said the findings indicate that highly variable BMI could be linked to a high-risk phenotype for cardiovascular disease.
How BMI affects your overall health
BMI is associated with increased levels of adipose (fat) in your body and, in turn, can lead to numerous chronic health conditions.
“We know that central obesity and, in turn, waist circumference are independent risk factors for the development of atherosclerotic cardiovascular disease (i.e. stroke, heart attack, coronary artery disease, and peripheral vascular disease), diabetes, and kidney disease,” Dr. Hosam Hmoud, a cardiology fellow at Northwell Lenox Hill Hospital in New York who was not involved in the study, told Healthline.
Elevated levels of adipose tissue release pro-inflammatory chemical messengers in the body that accelerates the development of high cholesterol and inflammation leading to plaque buildup in your arteries (atherosclerosis), insulin resistance which causes diabetes, and high blood pressure (hypertension), Hmoud explained.
Having a BMI in the normal range is an important marker for overall health for a number of reasons, experts say.
“Excess weight puts additional burden on the heart, the circulatory system, and the joints in the body,” said Brooke Aggarwal, an assistant professor of medical sciences and behavioral cardiology expert at Columbia University Vagelos College of Physicians and Surgeons in New York who was not involved in the study.
“Excess adipose tissue also leads to increased blood pressure, elevated triglycerides and cholesterol, and poor blood sugar control, which contributes to increased risk for developing cardiovascular disease, the leading cause of death globally,” Aggarwal told Healthline.
The health risks of high BMI and low BMI
BMI as it relates to overall health is a U-shaped relationship.
“Very low or high BMI associated with increased morbidity and mortality,” John Higgins, a sports cardiologist with UTHealth Houston who was not involved in the study, told Healthline.
Here is a general guideline:
- Optimal for adults is BMI between 18.5 and 25
- BMI less than 18.5 – A person is considered underweight
- BMI between 25 and 30 is considered overweight
- BMI over 30 is considered obese.
Fluctuating BMI and heart health
Highly variable BMI may be associated with cardiovascular events in several different ways.
“It’s possible that every time the weight is regained, cardiovascular risk factors such as blood pressure, cholesterol, and glucose inch higher, above the baseline level, and this is known as the ‘repeated overshoot theory‘,” Aggarwal said.
In addition, weight that is lost is usually a mix of fat and some lean muscle tissue, whereas weight that is regained is typically all adipose tissue, he explained.
This fat may be preferentially deposited in the abdomen and abdominal fat has been strongly associated with risk for cardiovascular disease.
Ways to manage your BMI
To improve your BMI, Hmoud recommends 30 minutes of adequate exercise at moderate intensity for at least 5 days per week.
He also suggests modifying your diet to include more Mediterranean-based foods (i.e. olive oil, fish, vegetables), and seeing your primary doctor on a regular basis to monitor your weight.
“BMI reduction decreases the rate of major adverse cardiovascular events, including stroke and heart attack, by decreasing basal levels of inflammation, lowering blood pressure and blood sugar, and improving your gut health, which also decreases inflammation,” said Hmoud. “Supplementation of a healthy lifestyle with weight loss drugs such as GLP-1 RA (semaglutide) may also be helpful in the setting of refractory weight loss efforts.”
When thinking about BMI, experts say it’s important to consider the bigger picture in terms of lifestyle and developing healthy long-term habits.
“I think the study highlights the importance of trying to achieve a healthy body weight in a sustainable way and one that can become a lifestyle rather than a short-term fix. Conventional diets that focus on eliminating entire food groups and severe calorie restriction often fail to yield sustained weight reduction and health benefits,” Aggarwal said.
Strict short-term diets can lead to a pattern of restricting and bingeing over the long-term. Intuitive and/or mindful eating is a more achievable approach to weight management that may lead to gentle weight loss long-term and improvement of other physiological parameters, such as inflammation, Aggarwal explained.
“We and others have also shown that eating a large percentage of one’s total daily calories in the evening meal is associated with greater risk of elevated BMI and blood pressure, so eating the majority of your calories earlier in the day may be a good strategy for managing weight, without severe restriction,” he added.
“You can calculate your own BMI by dividing your weight in pounds by your height in inches squared, and then multiplying by 703,” said Aggarwal.
To learn more specific information about own BMI, try this adult BMI calculator.
Elon Musk Takes Ketamine to Help Treat Depression: Does It Work?
- In a recent interview, Elon Musk revealed that he has a prescription for ketamine to treat depression.
- Ketamine is a powerful anesthetic that research indicates can help treat depression, but it is not currently FDA-approved for that or any other psychiatric indication.
- Experts told Healthline that Musk’s interview will raise the profile of the drug, which could lead to more seeking treatment, but also more misuse.
Elon Musk revealed that he takes ketamine for depression in a recent interview with former CNN host Don Lemon.
The tech mogul told Lemon that he hoped by speaking out about the drug that it might “help other people.”
While remaining generally tight-lipped about the specifics, Musk did have this to say about his ketamine usage in the interview:
“There are times when I have a sort of negative chemical state in my brain, like depression, I guess — depression that’s not linked to any negative news. Ketamine is helpful for getting one out of a negative frame of mind.”
Experts contacted by Healthline agreed that Musk’s revelation would certainly help to raise the profile of the drug and its reputation as a treatment for depression.
However, they also noted reservations that it might lead to misuse outside appropriate medical and psychiatric settings.
What is ketamine?
Ketamine hydrochloride is an FDA-approved anesthetic that was developed some fifty years ago and is still used today.
It is a Schedule III non-narcotic substance, according to the Drug Enforcement Agency, and has currently accepted medical uses.
But Ketamine also has a reputation as an illicit party drug that is known to cause hallucinations and a relaxed, disconnected feeling.
In the past twenty years, researchers have increasingly investigated ketamine for its potential use in a wide variety of mental health conditions, including:
- depression (especially treatment-resistant depression)
- substance use disorder
- post-traumatic stress disorder (PTSD)
- anxiety
Ketamine infusion therapy or intravenous ketamine is the most widely studied form of ketamine therapy for psychiatric disorders. Typically, a patient will receive a dose of the drug while under observation at a clinic and will then receive several maintenance doses over the following months.
There is no set dosage or infusion schedule; protocols may vary from clinic to clinic and patient to patient.
Simultaneously, researchers also began looking at similar drug formulations. In 2019, the Food and Drug Administration approved Spravato (esketamine) for treatment-resistant depression. However, esketamine is not ketamine and is administered via a nasal spray rather than intravenously.
Among these conditions, research indicates that the strongest evidence for ketamine therapy is for treatment-resistant depression, according to an expert review in The AmericanJournal of Psychiatry from 2021.
Despite mounting evidence, ketamine is currently not FDA-approved for any psychiatric disorders, but it can be prescribed by a licensed doctor.
“Ketamine infusion therapy or IV ketamine is not approved by the FDA. It’s really only been within the last couple decades that there’s been increased attention by the public and also by, psychiatry researchers and clinicians in using this in a clinical setting,” Dr. Jeffrey Zabinski, MD, an Assistant Professor of Psychiatry at the Columbia University Medical Center told Healthline.
The Columbia University Medical Center does offer ketamine infusion therapy as part of their psychiatric services.
What health experts think of Musk’s use of Ketamine to treat depression
Referring to Musk’s interview, Zabinski said, “There’s a positive opportunity for education when something like this comes up. The flip side of it is that ketamine is absolutely not appropriate for everyone. So you have to make sure to work with a psychiatrist or other mental healthcare professional to make sure that if there are other options that are safer, that those are explored before going to ketamine.”
Asked by Lemon if he ever abuses the drug, Musk responded, “I don’t think so. If you use too much ketamine, you can’t really get work done, and I have a lot of work.”
He went on to explain his ketamine usage and said that he only uses “a small amount once every other week.”
Dr. Boris Heifets, MD, PhD, an Assistant Professor in the Department of Anesthesiology & Perioperative Medicine at Stanford Medicine, also told Healthline that Musk’s interview is likely to help destigmatize mental health. However, he was more blunt about the downsides:
“Someone could listen to that interview and say, ‘Hey, I’m depressed, and it sounds like this guy, who is very high functioning, says it’s okay, then maybe it’s going to be good for me. Maybe I don’t need to have a doctor tell me what’s what because I don’t trust the medical establishment. I’m just going to get some ketamine.’ And that is a problem. I feel very comfortable saying that worries me a lot.”
Is ketamine safe?
Ketamine has a strong safety profile and has been used professionally in medical settings for decades. However, there are serious concerns about the dangers posed when the drug is used recreationally.
There are also questions about the long-term safety of ketamine infusion therapy for depression.
“Ketamine is exceptionally safe when given once. We have fifty years of experience with ketamine being given to millions of people in operating rooms around the world. But we also know ketamine is a drug abuse,” said Heifets.
Even for those prescribed ketamine, more research is needed about safety.
“There’s a lot we don’t know about its risk profile that we should attend before making determinations,” he said.
As a potential drug for misuse, ketamine is complicated. While there is some misuse potential, research has also found that ketamine may play a role in the treatment of substance disorders.
“Ketamine has been abused historically in the past few decades. So, it’s something that we have to pay extra attention to when patients have a history of substance use disorders. The complicated thing is, there are some studies that show that sometimes doses of ketamine can be helpful for substance use disorders.”
Health Risks of Ketamine
Ketamine has the potential for both short and long-term health risks. Immediately after taking the drug, individuals may experience:
- Hallucinations
- Feeling drunk
- Sedation
- Disorientation
- Nausea
Overdosing on ketamine can result in unconsciousness and dangerously slowed breathing.
In the long-term, ketamine use can lead to:
- Urinary and bladder problems
- Abuse and misuse
- Increased blood pressure
- Psychiatric events
The bottom line
Elon Musk recently discussed his prescription for ketamine to treat depression.
Ketamine is a powerful, FDA-approved anesthetic that research indicates is also an effective therapy for treatment-resistant depression.
However, the drug is not FDA-approved for any psychiatric disorders.
Experts say that while Musk speaking out may be helpful to destigmatize mental health, it may also lead to increased interest in the drug, which has the potential for misuse.