Wegovy & Ozempic Shortage Over: Supply Stabilizes and FDA Moves to Limit Compounded Alternatives.

 

GLP-1 Availability Shifts: FDA Actions Impact Compounded Wegovy and Ozempic After Removal From Drug Shortage List

February 21, 2025 - The landscape of GLP-1 medication availability is undergoing significant changes, with the U.S. Food and Drug Administration (FDA) announcing the resolution of shortages for key drugs like semaglutide (Wegovy and Ozempic) and tirzepatide (Zepbound and Mounjaro). These decisions have major implications for compounding pharmacies and patient access to these popular weight-loss and diabetes medications. Patients who rely on affordable medication from reputable compounding pharmacies may now be required to purchase the brand named GLP-1 medications at a considerably higher cost which may make them unaffordable to many of the same people who rely on them 

Semaglutide Shortage Resolved, Compounding Restrictions Imminent:

The FDA has officially determined that the shortage of semaglutide injection products, including Wegovy and Ozempic, is resolved. This decision follows confirmation from Novo Nordisk, the manufacturer, that their production capacity can meet current and projected national demand. While localized supply disruptions may occur as products move through the supply chain, the overall national shortage is considered over. Compounding pharmacies and organizations are determined to fight this ruling in the courts as the belief is that between diabetic patients and those who are reliant on them for weight loss, that the large manufacturers of the drugs will not be able to keep up with the demand despite their reassurances 

This resolution triggers restrictions on compounding pharmacies that have been producing versions of these drugs during the shortage. To ensure a smooth transition for patients, the FDA has provided a grace period:

• 503A Pharmacies (State-Licensed): Compounding, distribution, and dispensing of semaglutide injection products that are essentially copies of FDA-approved products is allowed for 60 calendar days from February 21, 2025, until April 22, 2025.
• 503B Outsourcing Facilities: Compounding, distribution, and dispensing of semaglutide injection products is allowed for 90 calendar days from February 21, 2025, until May 22, 2025.

Tirzepatide Shortage Also Addressed:

Similarly, the FDA has also declared the tirzepatide shortage resolved, following a re-evaluation of its previous determinations. This decision, mirroring the semaglutide action, activates similar grace periods for compounding pharmacies. Much like Wegovy and Ozempic, commercial grade Mounjaro (Tirzepatide) has been a huge breakthrough for weight loss and patients have had tremendous results while taking the subcutaneous injections. Unfortunately the grace period is about to end and many compounding pharmacies will no longer me manufacteuring these drugs which will spike the demand and costs for certain.

• 503A Pharmacies: Compounding, distributing or dispensing tirzepatide injections within 60 calendar days from December 19th 2024, until February 18, 2025.
• 503B Outsourcing Facilities: compounding, distributing or dispensing tirzepatide injections within 90 calendar days from December 19th 2024, until March 19, 2025.

It is important to note, that despite these grace periods, the FDA retains the authority to take action against compounders for violations of other statutory or regulatory requirements, particularly regarding substandard quality or unsafe products.

Impact on Compounding Pharmacies and Market Dynamics:

The FDA's decisions have significant market repercussions. Companies like Hims & Hers Health, which have heavily promoted compounded versions of GLP-1 medications, have seen substantial stock declines. The ability to produce and sell these compounded versions, which are often cheaper than brand-name drugs, is now significantly curtailed.

The Alliance for Pharmacy Compounding has raised concerns about the transition for patients currently relying on compounded medications, emphasizing the need for a smooth shift to FDA-approved alternatives.

Ongoing Monitoring of GLP-1 Availability:

The FDA continues to actively monitor the availability of other GLP-1 medications, including dulaglutide and liraglutide, which remain in shortage. The agency stresses that while manufacturers may report "available" status for certain products, this does not constitute an official FDA determination that the shortage is resolved.

Key Considerations:

• FDA Enforcement: The FDA emphasizes the legal restrictions on compounding copies of FDA-approved drugs, particularly when shortages are resolved.
• Patient Transition: Patients currently using compounded GLP-1 medications should consult with their healthcare providers to discuss transitioning to FDA-approved alternatives.
• Supply Chain Stability: While national shortages are resolved, localized supply disruptions may still occur.
• Safety and Quality: FDA-approved drugs undergo rigorous review for safety, effectiveness, and quality, whereas compounded drugs do not receive the same level of oversight but still receive quality control measures as do the pharmacies that manufacture them.

Where to Find Updates:

For the most current information on GLP-1 medication availability and drug shortages, please refer to the FDA’s Drug Shortages Database.

Estrogen Levels in Women: Understanding Its Role in Women's Health

Estrogen Levels in Women: A Key to Understanding Female Health

How Estrogen Affects Women's Health: Signs, Symptoms, and Solutions

Many women come to us with generalized symptoms of perimenopause or menopause and have questions regarding their blood work. Often, we hear questions like “What are my estrogen levels?” and “What should my estrogen levels be at for my age?” It’s important to address what estrogen is and what role it plays in women’s health.  Estrogen is a group of steroid hormones that play a crucial role in the female reproductive system and their overall health. It’s one of the major hormones that’s responsible for the development of female sexual characteristics, regulation of the menstrual cycle, and helps influence various other bodily functions. Estrogen levels naturally fluctuate throughout a woman's life, and understanding these changes is important when it comes to maintaining well-being.  

What is Estrogen?

There are three main types of estrogen in women which are primarily produced in females by the ovaries, with smaller amounts coming from the adrenal glands and fat tissue.

·         Estradiol (E2): The most potent and abundant form of estrogen, primarily produced by the ovaries playing a key role in reproductive health and is measured in blood tests to assess estrogen levels.   Normal estradiol (E2) levels in women vary depending on their age and menopausal status:   Premenopausal women: 30 to 400 pg/mL and Postmenopausal women: 0 to 30 pg/mL

Estrone (E1): A weaker form of estrogen present in lower levels than estradiol. It becomes the dominant estrogen after menopause.  Individual levels will vary from one womean to the next but here is are general ranges. Premenopausal women: 27 to 231 pg/mL  Postmenopausal women: 0 to 125 pg/mL

Estriol (E3): The weakest form of estrogen, mainly produced during pregnancy. Its role in non-pregnant women is not fully understood.   Estriol levels are typically not measured in non-pregnant women.  

What Does Estrogen Do?

The million-dollar question is “What does estrogen do?”  Estrogen exerts its effects in women by binding itself to specific receptors in various tissues throughout the woman’s body. These receptors are found in tissue and organs such as:  

• Reproductive organs: Uterus, vagina, breasts  
• Brain: Affects mood, cognition, and sleep  
• Bones: Maintains bone density and strength  
• Heart: Influences cholesterol levels and blood vessel function  
• Skin: Contributes to skin elasticity and hydration  

Estrogen Levels Throughout Life

What do normal estrogen levels look like throughout a woman’s life? As it turns out, Estrogen levels will naturally fluctuate throughout a woman's life, influenced by puberty, menstrual cycles, pregnancy, and menopause.  This can be confusing at times and even cause unwanted symptoms such as mood change, hot flashes and night sweats, menstrual cycle irregularity to name a few but don’t worry. This is completely normal and can be addressed by your healthcare provider if needed.

• Puberty: Estrogen levels rise, triggering the development of female sexual characteristics, including breasts, menstruation, and changes in body shape.  
• Menstrual cycle: Estrogen levels fluctuate throughout the menstrual cycle, peaking just before ovulation and then declining.  
• Pregnancy: Estrogen levels steadily increase during pregnancy, supporting the growth and development of the fetus and see a boost of E3.  
• Menopause: Estrogen levels significantly decline as the ovaries stop producing eggs, leading to various physical and emotional changes and E1 becomes the dominant form of estrogen.  

Normal Estrogen Levels

Normal estrogen levels vary depending on age and menopausal status. Here's a general guideline for estradiol (E2) levels:

Premenopausal women: 30 to 400 pg/mL  

Postmenopausal women: 0 to 30 pg/mL  

It's important to note that these are just general ranges, and individual levels may vary.  Also keep in mind that these number will fluctuate and every patient is unique so if you suspect there may be an issue with your hormones, speak to your doctor about your concerns.  A healthcare provider can interpret estrogen levels in the context of a woman's overall health and medical history.

Effects of Low Estrogen

Low estrogen levels can lead to various symptoms, including:

• Menstrual irregularities: Changes in cycle length, flow, or missed periods  
• Hot flashes: Sudden feelings of warmth, sweating, and flushing  
• Vaginal dryness: Discomfort during intercourse  
• Sleep disturbances: Difficulty falling asleep or staying asleep  
• Mood changes: Irritability, anxiety, or depression  
• Decreased libido: Reduced sexual desire  in women
• Bone loss: Increased risk of osteoporosis
• Cognitive changes: Difficulty concentrating or remembering things

Estrogen Replacement Therapy (ERT)

Hormone Replacement Therapy for women is a very common treatment option for women experiencing the unwanted signs and symptoms of perimenopause of menopause. It often includes estrogen, testosterone and progesterone. Estrogen replacement therapy (ERT) in particular involves taking medication to increase estrogen levels back to an optimal level for the patient. It is primarily used to manage menopausal symptoms and prevent bone loss. ERT can be delivered in various forms, including:  

• Oral tablets: The most common form of ERT. These are generally best taken after a meal to reduce the risk of stomach upset and improve absorption. Some women find it helpful to take them in the morning to maintain consistent hormone levels throughout the day.
• Transdermal patches: Applied to the skin, delivering estrogen directly into the bloodstream. These are typically replaced every few days. The time of day for application is less critical, but it's important to choose a consistent time and location for each application.  
• Topical gels or creams: Applied to the vagina or vulva. The time of day for application may depend on the specific product and individual needs.
• Vaginal rings: Inserted into the vagina, releasing estrogen over time. They provide a continuous release of hormones.

Benefits of ERT for Women

ERT can provide several benefits, including:

• Relief from menopausal symptoms: Reduces hot flashes, vaginal dryness, sleep disturbances, and mood changes  
• Prevention of bone loss: Helps maintain bone density and reduce the risk of osteoporosis  
• Improved quality of life: Enhances overall well-being and reduces the impact of menopausal symptoms  

Risks of ERT

Like all medications and medical treatments ERT also carries potential risks, including:

• Increased risk of certain cancers: ERT may increase the risk of breast cancer and endometrial cancer so it’s important to get screened. The U.S. Preventive Services Task Force (USPSTF) recommends that women aged 40 to 74 years with average risk get screened every 2 years, however, the American Cancer Society (ACS), recommend annual mammograms starting at age 45, or even 40, depending on individual risk factors and preferences.   Higher risk patients with a family history of breast cancer should get tested more frequently.
• Increased risk of blood clots: May increase the risk of deep vein thrombosis and pulmonary embolism  
• Possible Increased risk of stroke and heart attack: ERT May increase the risk of cardiovascular events, especially in women with existing risk factors. Studies on the relationship between ERT and CVD have yielded mixed results. Some studies have shown an increased risk of heart attack, stroke, and blood clots in women taking ERT, while others have not found a significant association. Its important to discuss whether you’re in a high risk category for your age, overall health, family history and time since the onset of menopause to determine if there is an increased risk.

Who Should Consider ERT?

ERT is not suitable for all women. It is important to discuss the benefits and risks with a licensed and experienced healthcare provider to determine if it is appropriate for you. There are several factors to consider including:

• Severity of menopausal symptoms: ERT may be more beneficial for women with severe symptoms that significantly impact their quality of life. Oten mild symptoms subside fairly quickly for many women.
• Risk factors for certain cancers: Women with a personal or family history of breast cancer or endometrial cancer may have an increased risk with ERT and should weigh the risk/reward of HRT.
• Risk factors for cardiovascular disease: Women with existing heart disease or risk factors for cardiovascular disease may have an increased risk with ERT and should look for other ways to alleviate symptoms first.

Alternatives to ERT

There are alternative treatments for managing menopausal symptoms and preventing bone loss for women, including:

• Lifestyle changes: Regular exercise, a healthy diet, and stress management can help alleviate menopausal symptoms. Strength training in particular is beneficial. Strength training can stimulate the production and balance of various hormones, including growth hormone, testosterone, and estrogen. This can help alleviate symptoms associated with hormone imbalances, such as mood swings, fatigue, and weight gain.  
• Non-hormonal medications: Certain medications can help reduce hot flashes and improve sleep.   These medications work through different mechanisms than hormone replacement therapy (HRT) and may be suitable for women who cannot or choose not to take HRT.  

Here are some common non-hormonal medications used for hot flashes and sleep problems during menopause:

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs): These antidepressants can also help reduce hot flashes. Examples include paroxetine (Brisdelle), venlafaxine (Effexor XR), and desvenlafaxine (Pristiq).  

Gabapentinoids: Gabapentin (Neurontin, Gralise) and pregabalin (Lyrica) are anti-seizure medications that can also reduce hot flashes. Gabapentin can also improve sleep quality.  

Clonidine: This medication, typically used to treat high blood pressure, can also help reduce hot flashes.  

Fezolinetant (Veozah): This is a newer non-hormonal medication specifically for hot flashes. It works by blocking a pathway in the brain that helps regulate body temperature.  

It's important to note that these medications may have side effects, and their effectiveness can vary among individuals. It's crucial to discuss the benefits and risks of each medication with a healthcare provider to determine the most appropriate treatment plan.

 

• Herbal remedies: Several herbal remedies have been traditionally used to manage hot flashes and sleep problems during menopause. However, it's important to note that the effectiveness and safety of these remedies can vary, and scientific evidence supporting their use may be limited. It's crucial to consult with a doctor before trying any herbal remedy, as they may interact with other medications or have potential side effects. This list is not intended as an endorsement of any herbal remedy or to treat any symptoms but instead is for informational purposes as to how menopause symptoms have been treated without using hormone therapy. Here are some commonly used herbal remedies for hot flashes and sleep problems during menopause:

Black cohosh: This herb has been traditionally used to relieve hot flashes, night sweats, and other menopausal symptoms. However, studies on its effectiveness have yielded mixed results.  

Red clover: Red clover contains isoflavones, which are plant-based compounds that can mimic estrogen's effects. Some studies suggest that red clover may help reduce hot flashes.  

Soy: Soybeans are rich in isoflavones and may help alleviate hot flashes and improve sleep quality.  

Evening primrose oil: This oil contains gamma-linolenic acid, which may help regulate hormone levels and reduce hot flashes. However, scientific evidence supporting its use is limited.  

Valerian root: Valerian root has been traditionally used to promote relaxation and improve sleep quality. It may be helpful for women experiencing sleep problems during menopause.  

Sage: Sage has been used to reduce hot flashes and night sweats. Some studies suggest that it may be effective in alleviating these symptoms.  

It's important to choose high-quality herbal supplements from reputable brands and follow recommended dosages. Be aware of any potential side effects or interactions with other medications. If you experience any adverse reactions, discontinue use and consult with a healthcare provider.

As women age, they start to experience changes and often these changes can be directly attributed to hormonal health. Estrogen in particular plays a vital role in women's health throughout their lives. Understanding estrogen levels and their fluctuations is essential for maintaining well-being and improving quality of life. ERT can be an effective treatment for managing menopausal symptoms and preventing bone loss, but it is important to discuss the benefits and risks with a healthcare provider to determine if it is appropriate.   For more information visit us online or call to schedule an appointment to speak with our physician Dr. Timothy W. Mackey.

Managing Menopause Symptoms Through Hormone Therapy

From Perimenopause to Post-Menopause: What to Expect and How to Cope

Understanding Symptoms and Treatment Options for Women

Menopause is a natural biological process that marks the end of a woman's reproductive years. It's a significant transition, often accompanied by various physical and emotional changes. Understanding what menopause is and the available treatment options can empower women to manage this phase of life comfortably.

What is Menopause?

Menopause is officially diagnosed when a woman has gone 12 consecutive months without a menstrual period. This typically occurs between the ages of 45 and 55, with the average age being 51 in the United States.

The journey to menopause, known as perimenopause, can begin several years earlier. During this time, the ovaries gradually produce less estrogen and progesterone, leading to irregular periods and other symptoms.

Some women have no or mild menopausal symptoms and may even feel relieved when they no longer need to worry about periods or getting pregnant. For other women, the menopausal transition can bring various symptoms, including hot flashes, night sweats, trouble sleeping, joint and muscle discomfort, pain during sex, low sex drive, moodiness and irritability, forgetfulness, difficultly concentrating, or a combination of these.

Women who are concerned by menopausal symptoms should talk with a doctor about lifestyle changes. There are treatments available to help with symptoms of menopause, like hormone therapy, medication or lifestyle adjustments.

 

Common Symptoms of Menopause

The decrease in hormone levels during perimenopause and menopause can cause a range of symptoms, varying in intensity and duration from woman to woman. Some of the most common symptoms include:

• Changes in menstruation: This is often the first noticeable sign, with periods becoming irregular, heavier or lighter, or shorter or longer.
• Hot flashes: These sudden feelings of warmth, often accompanied by sweating and flushing, can disrupt daily life and sleep.
• Night sweats: Hot flashes occurring at night can lead to excessive sweating and sleep disturbances.
• Sleep problems: Difficulty falling asleep or staying asleep is common due to hormonal fluctuations and night sweats.
• Vaginal dryness: Reduced estrogen levels can cause vaginal dryness, leading to discomfort during intercourse.
• Mood changes: Some women experience mood swings, irritability, anxiety, or depression during this time.
• Other physical changes: These may include weight gain, changes in skin elasticity, and increased risk of urinary tract infections.

How to Treat Menopause Symptoms

While menopause is a natural process, its symptoms can significantly impact a woman's quality of life. Fortunately, several treatment options are available to help manage these symptoms:

Hormone therapy (HT): This involves replacing the hormones estrogen and sometimes progesterone to alleviate symptoms like hot flashes, vaginal dryness, and sleep problems. HT is a personalized treatment with potential risks and benefits that should be discussed with a healthcare provider.

Types of Hormone Therapy

Hormone therapy for women is available in a few primary forms:

• Estrogen Therapy (ET): This treatment involves taking estrogen alone, typically in a low dose. It is available in various forms, including patches, pills, creams, vaginal rings, gels, and sprays. However, estrogen alone is only recommended for individuals who have had a hysterectomy, as using it without a progestogen increases the risk of uterine complications.
• Estrogen-Progestogen Therapy (EPT): Also known as combination therapy, this treatment includes both estrogen and a progestogen, which can be either natural progesterone or a synthetic progestin. This therapy is necessary for individuals who still have their uterus to help protect against uterine lining complications.
• Testosterone Therapy: Testosterone for women is sometimes included in hormone replacement therapy (HRT) to address symptoms of low testosterone, which naturally declines with age or due to medical conditions. While estrogen and progesterone are the primary hormones in female HRT, testosterone supplementation can help improve energy levels, libido, mood, and muscle mass. It is often prescribed in low doses through creams, gels, or injections. However, therapy must be carefully monitored to avoid side effects such as acne, hair growth, or voice changes.

Hormone therapy carries potential risks, so it's essential to consult your healthcare provider to determine if it's a suitable option based on your health history, age, and individual needs.

 

Medications: Certain medications can help manage specific symptoms, such as antidepressants for mood changes or medications to improve sleep.

Lifestyle adjustments: Making healthy lifestyle choices can significantly ease menopause symptoms. This includes:

Maintaining a healthy diet: Focus on fruits, vegetables, whole grains, and lean protein. Foods to try include beans, soybeans, lentils, chickpeas to name a few.

Regular exercise: Engage in regular physical activity to improve overall health and reduce symptoms.

Stress management: Practice relaxation techniques like yoga, meditation, or deep breathing exercises.

Getting enough sleep: Aim for 7-8 hours of quality sleep per night.

Avoiding triggers: Identify and avoid triggers that worsen hot flashes, such as spicy foods, alcohol, or caffeine.

There are several nonhormonal prescription options available from your healthcare provider which may be able to help manage some of the symptoms of menopause. These may include:

• Birth control pills to regulate hormone levels.
• Antidepressants (SSRIs and SNRIs) to help with mood swings and hot flashes.
• Gabapentin (a seizure medication) or fezolinetant to alleviate hot flashes.
• Oxybutynin, typically used for overactive bladder, can also reduce hot flashes.
• Vaginal creams and lubricants to relieve vaginal dryness.

Consult your healthcare provider first to determine if nonhormonal medications are suitable for your symptoms based on your medical history and unique needs.

Health Risks Associated with Menopause

Following menopause, the likelihood of developing conditions such as osteoporosis and cardiovascular disease rises due to declining estrogen levels. Your healthcare provider may monitor your health closely to assess potential risks and recommend appropriate treatments if necessary.

Osteoporosis

Osteoporosis occurs when bone density decreases, making bones more fragile and prone to fractures. Estrogen plays a crucial role in maintaining bone strength by signaling bone cells to slow down breakdown. On average, individuals lose about 25% of their bone mass from menopause to age 60. Healthcare providers may recommend bone density testing (bone densitometry) to assess calcium levels and bone health over time.

Cardiovascular Disease

The risk of cardiovascular disease increases post-menopause due to factors such as:

• Reduced estrogen levels.
• Elevated blood pressure.
• Lifestyle choices like smoking, alcohol consumption, and poor diet.
• Decreased physical activity, which may contribute to high cholesterol and other health concerns.

Maintaining a healthy lifestyle and seeking regular medical evaluations can help mitigate these risks.

 

Seeking Professional Guidance

It's crucial for women experiencing menopause symptoms to consult with a healthcare provider experienced in HRT for women. They can assess individual needs, discuss treatment options, and help create a personalized plan to manage symptoms effectively.

Remember: Every woman's experience with menopause is unique. By understanding the process, recognizing the symptoms, and exploring available treatments, women can navigate this transition with confidence and maintain a healthy, fulfilling life. To schedule a free initial consultation call or text us at 561-277-8260 or email us at info@novagenix.org