Generic Name: Evista
What is Evista?
I feel that it is in your readers' best interest to be presented with this critical information, as these facts were not included in the Epstein and Cody editorial. Angela Sekston Eli Lilly and Company Letter 1Recently there have been some media reports questioning the safety of Evista raloxifene hydrochlorideLilly's new drug for the prevention of postmenopausal osteoporosis. These reports suggest that Eli Lilly and Company, with the FDA's "complicity," may have suppressed critical information about the drug and its purported risk for ovarian cancer.
The allegations raised in these reports are without merit and are in conflict with the totality of safety data accumulated on Evista. In light of these accusations, it is important for you to understand the facts. It is also well-established that mice are especially susceptible to development of ovarian tumors.
Because the animals were treated with Evista throughout their entire reproductive lives, hormonal changes occurred that are known to cause ovarian tumors in rodents. In contrast, Evista does not produce similar hormonal changes in postmenopausal women.
Visit the FDA MedWatch website or call 1-800-FDA-1088. In clinical trials, EVISTA-treated women had an increased risk of venous thromboembolism deep vein thrombosis and pulmonary embolism. Other venous thromboembolic events also could occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with EVISTA than with placebo. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy.
Because immobilization increases the risk for venous thromboembolic events independent of therapy, EVISTA should be discontinued at least 72 hours prior to and during prolonged immobilization e. In addition, women taking EVISTA should be advised to move about periodically during prolonged travel.
In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with EVISTA. During an average follow-up of 5. EVISTA had no significant effect on all-cause mortality. EVISTA should not be used for the primary or secondary prevention of cardiovascular disease. There is no indication for premenopausal use of EVISTA.
Safety of EVISTA in premenopausal women has not been established and its use is not recommended. EVISTA should be used with caution in patients with hepatic impairment. Women with this medical history should have serum triglycerides monitored when taking EVISTA.
How should I take Evista?
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture. The active substance in Evista, raloxifene, is a selective oestrogen receptor modulator SERM.
Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb. Three studies looked at the prevention of osteoporosis in 1,764 women who took either Evista or placebo a dummy treatment for two years. The studies measured the density of the bones.
What should I avoid while taking Evista?
Other lifestlye issues related to healthy bones are followed. Since beginning treatment with Evista, I have had three DEXA scans, and my bone density has remained stable. I have had no broken bones or spinal fractures during this period, and I have heighth has remained the same. I take one 60mg pill daily which can be taken anytime of the day, with or without food. Other Osteoporosis prevention drugs have many side effects.
This particular drug has almost no side effects and has shown evidence in clinical testing to reduce the occurance of breast cancer.
Evista side effects
Raloxifene decreases the risk of developing invasive breast cancer by blocking the effects of estrogen on breast tissue. This may stop the development of tumors that need estrogen to grow. Raloxifene also prevents and treats osteoporosis by mimicking the effects of estrogen to increase the density thickness of bone. Raloxifene comes as a tablet to take by mouth. It is usually taken once a day, with or without food. It is important to remember to take this medication every day to get the maximum benefit from taking it.
If you forget to take a dose, resume your regular schedule - do not double your dose to make up for the missed dose.
Common Evista ide effects may include:
I have been on Evista at least 16 years for Osteopenia.
They are available as follows: Tablet Imprint LILLY 4165 4165 Presentations and NDCs Bottles of 30 unit of use 0002-4165-30 0002-4184-30 Bottles of 100 unit of use 0002-4165-02 0002-4184-02 Bottles of 2000 0002-4165-07 0002-4184-07 16.
Reduces the absorption and enterohepatic cycling of raloxifene.
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By measuring and analyzing incremental new prescriptions for doctors who attended the advisory board meetings, Lilly was using this intervention as a tool to promote and sell Evista. As part of the consent decree, Lilly has agreed to comply with the terms of a permanent injunction, which will require the company to implement effective training and supervision of its marketing and sales staff for Evista, and ensure that any future off-label marketing conduct is detected and corrected.
Lilly has agreed to be permanently enjoined from directly or indirectly promoting Evista for use in preventing or reducing the risk of breast cancer, reducing the risk of cardiovascular disease, or for any other unapproved use in a manner that violates the Food, Drug, and Cosmetic Act unless and until FDA approves the drug for an additional use or uses.
The information is an allegation only.
Where can I get more information?
The incidence of all-cause mortality was similar among groups: 23 0.
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