Lack Of Us Food And Drug Administration Regulation For Compounded Preparations
Compounded preparations are not regulated by the FDA. Although technically all compounded prescription drug preparations could be considered unapproved new drugs, the FDA has adopted a policy of enforcement discretion, allowing legitimate preparation of compounded formulations to be regulated by state boards of pharmacy, with a provision of stepping in when dangerous practices must be addressed and when drug manufacturing occurs under the guise of compounding. There are currently no specific regulations by the FDA on what constitutes a legitimate claim for compounded drug preparations. In general, states regard compounding to be part of the practice of pharmacy. In addition, individual states pharmacy acts usually permit other licensed practitioners to engage in the practice of pharmacy compounding for their own patients.
Symptoms And Effects Of Menopause
Menopause is the time in a womans life when menstruation ceases, signaling the end of her reproductive ability. The timing of menopause varies widely, but this event often occurs naturally in women in the fourth or fifth decades of life, at a mean age of 51 years. Certain medical or surgical conditions may induce the cessation of menses before this age. If menopause occurs before the age of 40 years, it is considered premature.
The STRAW classification proposed by the American Society for Reproductive Medicine depicts the natural transition in a female’s life from the reproductive years to the time of menopause.
The reproductive years are divided into early, peak, and late and are characterized by regular menstrual cycles . This is followed by the stage of menopausal transition, which earlier on is characterized by a variable cycle length that is more than 7 days different from normal. During the latter stages of this transition phase, women experience intervals of amenorrhea of more than 60 days. When this duration of amenorrhea lasts for up to 12 months, it is classified as postmenopause. The stage of perimenopause spans from the beginning of the stage of menopause transition up until the completion of 1 year following the final menstrual period.
Important Questions To Ask About Menopause Hormone Medicines
- Are hormones right for me? Why?
- What are the benefits?
- What are the serious risks and common side effects?
- How long should I use hormone therapy?
- What is the lowest dose that will work for me?
- Are there any non-hormone medicines that I can take?
Want more information about menopause? Check the FDA website at: www.fda.gov/menopause
The drug and risk information in this booklet may change. Check Drugs@FDA for the latest facts on each product listed in this booklet.
Fda Approves Oral Testosterone Replacement Therapy Kyzatrex
The Food and Drug Administration has approved Kyzatrex for testosterone replacement therapy in adult males for conditions associated with deficiency or absence of endogenous testosterone:
- Primary hypogonadism : testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins above the normal range.
- Hypogonadotropic hypogonadism : gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
The approval was based on data from an open-label, 6-month, phase 3 study that evaluated the efficacy and safety of Kyzatrex in 155 men with hypogonadism. Patients received Kyzatrex at a starting dose of 200mg twice daily with meals the dosage was adjusted on days 28 and 56 based on plasma testosterone concentration.
Kyzatrex is a Schedule III controlled substance. The product is supplied as 100mg, 150mg, or 200mg of testosterone undecanoate capsules in 90-count bottles. It is not substitutable with other oral testosterone undecanoate products.
What Do Hormone Pellets For Menopause Cost
The cost of hormone pellet therapy can vary depending on the provider, but an average cost may be close to $1,536 each year.
Healthcare insurance may cover FDA-approved hormone therapy, but the extent of the coverage may vary among plans. Most insurance companies are unlikely to cover compounded bioidentical hormone therapy because it is not FDA-approved.
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Side Effects And Risks Of Bhrt
While the FDA has approved some preparations of bioidentical estradiol and progesterone, it hasnt approved any compounded bioidentical hormones. There are claims that bioidentical hormones are safer and more effective than traditional HRT because theyre identical in structure to those produced in the body. But these claims have not been confirmed by large-scale, reputable studies. The FDA urges caution when using compounded products.
Research has shown that hormone replacement therapy in general may increase the risk for certain conditions and diseases including:
Talk to your doctor about which form may be best for you and your lifestyle. Youll likely need to be monitored regularly once you begin BHRT to evaluate your bodys response. However, the FDA cautions against monitoring hormone levels via blood and saliva tests. These only tell you your hormone levels at a moment in time and can vary widely throughout the day.
The FDA recommends that if you do choose any form of hormone therapy that you use the lowest dose that produces results. The FDA also says you should use it for the shortest length of time possible.
What Are Bioidentical Hormones
Bioidentical hormones are processed hormones designed to mimic the hormones made by your bodys glands. Taking bioidentical hormones can help people who experience symptoms of low or unbalanced hormones. This is often the case for people experiencing symptoms of perimenopause or menopause.
Hormones are chemicals made by your endocrine glands. They are messengers that tell other parts of your body how and when to work. Hormones affect many systems and functions in your body. Even the slightest imbalance can cause symptoms that interfere with your day. Healthcare providers may recommend hormone replacement therapy as a treatment for these symptoms.
Bioidentical hormone therapy uses processed hormones that come from plants. Estrogen, progesterone and testosterone are the most commonly used bioidentical hormones.
Some prescription forms of bioidentical hormones are premade by drug companies. The U.S. Food and Drug Administration has approved certain types of bioidentical hormones. Other forms of bioidentical hormones are custom-made by a pharmacist based on a healthcare provider’s prescription. These are compounded bioidentical hormones.
The compounded forms have not been tested and approved by the FDA. Though it is often advertised that products that are made from plants are “natural” choices, they are altered in a lab so are no longer natural when done with processing.
Conventional hormone therapy vs. bioidentical hormone therapy
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Are Herbs And Other Natural Products Useful In Treating Symptoms Of Menopause
At this time, FDA does not know if herbs or other natural products are helpful or safe.
Should I use estrogen just to prevent thin bones?
You can, but there are also other medicines and things you can do to help your bones. Speak to your healthcare provider.
Should I use hormone therapy to protect the heart or prevent strokes?
No, do not use hormone therapy to prevent heart attacks or strokes.
Should I use hormone therapy to prevent memory loss or Alzheimers disease?
No, do not use hormone therapy to prevent memory loss or Alzheimers disease.
Do hormones protect against aging and wrinkles or increase my sex drive?
Studies have not shown that hormone therapy prevents aging and wrinkles or increases sex drive.
How Much Does Bioidentical Hormone Replacement Therapy Cost
The cost of bioidentical hormone replacement depends on your specific regimen. For example, several FDA-approved bioidentical hormones, like Estrace, have lower-cost generic versions. Other brand-name-only products, like Bijuva, may be more expensive.
The cost of compounded bioidentical hormones can be even more varied. Thats because pricing can be different from pharmacy to pharmacy, even for a similar product. And compounded medications arent always covered by insurance. So, youll likely need to pay out-of-pocket for your prescription.
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What Are The Symptoms Of Menopause
Every womans period will stop at menopause. Some women may not have any other symptoms at all. As you near menopause, you may have:
- Changes in your periodtime between periods or flow may be different.
- Hot flashes getting warm in the face, neck, or chest, with and without sweating.
- Night sweats that may lead to problems sleeping and feeling tired, stressed, or tense.
- Thinning of your bones, which may lead to loss of height and bone breaks .
When Will Bijuva Be Available
Bijuva will become available in the Spring of 2019.
A spokesperson from TherapeuticsMD, the company that markets Bijuva, said the medicine will be covered by insurance, and there will be a patient affordability program in place for eligible women.
This treatment will be covered by insurance, unlike compounded hormone therapy products, where women mostly pay out of pocket, said Pinkerton. It is a novel, effective, and often requested therapy for symptomatic menopausal women and their healthcare providers.
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How Does My Healthcare Provider Select My Dose
People on hormone treatment are watched very closely by their healthcare providers. The goal is to relieve symptoms with the lowest dose possible for the shortest amount of time. Depending on your healthcare provider, you might have routine blood, urine or saliva tests to check your hormone levels. Your healthcare provider may adjust your dose based on your changing hormone needs.
The FDA recommends against using hormone levels to guide the dosing of hormone therapy in women, as normal levels fluctuate day to day. In particular, salivary hormone levels are known to fluctuate and have not been shown to be related to menopausal symptoms.
Are Testosterone Products For Women Approved By The Fda
While the hormone testosterone has been linked with raising female libido, preventing bone fractures and breaks and elevating mood, women considering the use of testosterone patches, rings, and creams should proceed with extreme caution. Read on to learn more about what women should be aware of before using testosterone products.
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Hormone Therapy And Breast Cancer
The association of hormone therapy with breast cancer may have different potential based on estrogen alone, estrogen and a progestin or conjugated estrogen plus bazedoxifene. Different medication formulations and dosages, timing of initiation and length of use may also affect occurrence of malignancy. Individual patient characteristics, combined with medical comorbidities and genetic risk factors and the interactions with hormone therapy are important but not yet clearly elucidated.
While the WHI confirmed an increased risk of breast cancer in users of CEE and MPA, the women in the estrogen alone arm had a nonsignificant reduction in breast cancer at 7.2 and 13 years. Smaller trials have also shown a nonsignificant reduction in breast cancer in women taking estrogen alone but observational studies have demonstrated increased risk
There are no RCT for assessing breast cancer in long- term users of estrogen therapy, but one small, randomized, non-blinded trial found no increased breast cancer risk at 10 and 16 years of use have shown mixed results
The effects of progestogen therapy with estrogens suggest micronized progesterone may have less risk on the development of breast cancer than the more potent medroxyprogesterone acetate . Randomized trials are needed.
Oral CEE and bazedoxifene prescribed to menopausal women followed for up to 2 years did not show an increased risk of breast cancer
Genitourinary Syndrome Of Menopause
Breast cancer survivors may suffer genitourinary syndrome of menopause . This consists of vulvar burning or itching, vaginal dryness or discharge, dyspareunia or post-coital spotting, and recurrent urinary tract infections or symptoms of dysuria, frequency, or urgency. These symptoms may result from menopause related to surgery, chemotherapy or use of post- treatment medications to reduce risk of recurrence. Genitourinary symptoms frequently arise 1-3 years after the onset of menopause but some women experience them earlier. BCSs are typically not candidates for conventional menopause therapies but nonhormonal vaginal moisturizers or lubricants may have limited use over the long term.
Newer management options have become available for all menopausal women experiencing genito-urinary symptoms, including the use of adrenal androgen DHEA in vaginal suppository, low-dose/ultra low-dose topical estrogen cream, tablet or vaginal ring, or an oral selective estrogen receptor modulator ospemifene. Use of these therapies may also reduce the incidence of urinary tract or bladder infections, a cause of significant morbidity in older women. Undiagnosed or untreated urinary infections may lead to urosepsis with an increased risk or long-term morbidity or mortality.
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Menopause Symptoms Impact Health And Work
Menopause symptoms arent limited to hot flashes and night sweats. Other symptoms of menopause include difficulty sleeping, difficulty concentrating, mood swings, depression, headaches, racing heart, vaginal dryness, decreased recent memory and decreased energy. For some women, these symptoms begin years before menopause.
Hot flashes are uncomfortable, but they are also related to other issues. Hot flashes can disrupt sleep and may cause mood changes, difficulty concentrating, and impairment of short-term memory. In one study, frequent hot flashes and night sweats were associated with a 50% increased risk of cardiovascular disease. And, if these hot flashes and night sweats persisted over time, then there was a 77% increased risk of later cardiovascular disease.
Given the health and career impact of menopause symptoms, its a problem that many clinicians are not well-informed on the current thinking regarding hormone therapy. Bluming explains that part of the problem stems from the fact that menopause education is currently offered to less than 25% of residents studying obstetrics/gynecology. This may also explain why some practitioners still refuse to prescribe hormones. Given that over 50 million women in the United States are over the average age of menopause , one would think menopause care would be a higher priority.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. You should have a complete physical exam, including blood pressure measurements, breast and pelvic exams, and a Pap test at least yearly. Follow your doctor’s directions for examining your breasts report any lumps immediately.
If you are taking hormone replacement therapy to treat symptoms of menopause, your doctor will check every 3 to 6 months to see if you still need this medication. If you are taking this medication to prevent thinning of the bones , you will take it for a longer period of time.
Before you have any laboratory tests, tell the laboratory personnel that you take hormone replacement therapy, because this medication may interfere with some laboratory tests.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Fda Approves New Hrt Warning Labels
Warnings Cite Health Risks of Estrogen Products
Jan. 8, 2003 — For women, it’s the closest thing to the final word on hormone replacement therapy . The FDA has asked that all labels on estrogen and estrogen-progestin HRT products be revised to carry a “high-level warning.”
The new box warning, the highest level of warning information in labeling, will state the increased risks for heart disease, heart attacks, strokes, and breast cancer. The warning also emphasizes that these products are not approved for heart disease prevention.
“We have approved all new labeling for Wyeth Pharmaceuticals for Prempro, Premarin, and Premphase,” said FDA spokeswoman Pam Winbourne, in a teleconference with reporters. “All other manufacturers are being faxed letters asking them to revise their labels in a similar fashion.”
“We believe that different estrogens and progestins act similarly, and in absence of data otherwise, women need to assume the risk with other estrogens and progestins are similar,” said Winbourne. “Other studies do show that estrogens and progestins are associated with these same side effects.”
The FDA also urges that women take only the lowest doses of estrogens and estrogen-progestin products — and for the shortest duration to achieve treatment goals, says Winbourne. “Women should regularly discuss with their healthcare providers if they need to continue treatment,” she said.
The FDA has also modified two of the approved uses for the products:
Menopause And Hormone Therapy
Although decreasing estrogen levels alone do not cause all menopausal symptoms, estrogenwith or without progestogen has been prescribed for many years to manage menopause. Estrogen was often prescribed to help alleviate symptoms of menopause, as well as to prevent cardiovascular disease and osteoporosis.
Some have recommended that the term hormone replacement therapy in menopause be changed to hormone therapy or menopausal hormone therapy , to reflect the shift in focus from replacing hormones to using them for symptomatic relief.
The Clinical Practice Guidelines of the Endocrine Society, 2015, note that for menopausal women < 60 years of age or < 10 years post menopause with bothersome vasomotor symptoms who do not have a contraindication or excess risk of cardiovascular disease or breast cancer and who are willing to take menopausal hormone therapy , that estrogen therapy or estrogen and progestin therapy be initiated.
The US Food and Drug Administration has approved hormone therapy for four indications: bothersome VMS, prevention of bone loss, genitourinary symptoms, and estrogen deficiency caused by hypogonadism, premature surgical menopause, or premature ovarian insufficiency . This does not encompass the management of POI in young or adolescent women, which requires different management protocols.
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