SOLSTICE ENDOMETRIOSIS IS A FRAUD
The ADAEC contacted the above-mentioned telephone numbers, and the gynaecology secretaries of the hospitals took the data of the patients, but then called you from the laboratories. The person in charge of the laboratories refused to give us the composition of the “NEW PHARMACIST” without knowing for sure that we already had it (found among hundreds of publications where this composition is omitted). When we told him what it was and that it was a fraud, that it only changed the administration route of the same one, of injectable to oral route but that it was leuprolide equally and its secondary effects, he refused to continue speaking.
IN NONE OF THE ADS OR IN SPANISH IN EUROPE COMES THE FARMACO, MANY HOURS OF SEARCH MAKES US FIND IT.
TOO STRONG FOR MEN IF THE EFFECT OF THE AGONISTS HAS BEEN STUDYED… AND THE WOMEN WANT TO APPLY IT
SIDE EFFECTS OF LEUPROLIDE
Contraindications have been selected based on their potential clinical significance. The risk-benefit ratio should be considered when the following medical problems exist: sensitivity to gonadorelin (synthetic gonadotropin releasing hormone (GnRH) analogs such as buserelin, goserelin, histrelin, LEUPRORELIN and nafarelin.
Treatment of endometriosis or anemia due to uterine leiomyomas Conditions causing decreased bone density, personal or family history of osteoporosis in women treated with LEUPRORELINE can result in loss of bone mineral density induced by hypoestrogenism and may be irreversible; major risks include chronic alcoholism and/or tobacco abuse; family history of severe osteoporosis and chronic use of medications such as anticonvulsants or corticosteroids that decrease bone mineral density, LEUPRORELINE should be used with caution in these patients.
Undiagnosed abnormal uterine bleeding: Use of LEUPRORELINE may delay diagnosis.
Treatment of prostatic carcinoma:
Urinary tract obstruction or history: Existing urinary tract obstruction should be treated before starting treatment with LEUPRORELINE; for patients with a history of urinary tract obstruction, there is an increased incidence of disease during initial treatment with LEUPRORELINE due to the initial increase in serum testosterone concentrations; close monitoring is recommended during the first few months of treatment; catheterization may be necessary.
Vertebral Metastasis: Worsening of symptoms during the first weeks of therapy with LEUPRORELINE with risk of neurological problems including paralysis
Treatment of metastatic breast cancer: It is essential to verify the absence of pregnancy. It is advisable, as with all other GnRH analogues, to monitor patients who present an osteoporotic state during prolonged treatment.
In patients who present a breast cancer, as with the other GnRH analogues, there may be a possible and transitory increase at the beginning of the treatment of signs and symptoms that must be treated symptomatically.
Patient monitoring: The following determinations are especially important in monitoring patients (some may require other determinations depending on their condition)
Bone density measurement: Recommended as necessary to monitor patient response during long-term LEUPRORELINE use including treatment of endometriosis over 6 months.
Treatment of central precocious puberty: Determinations of linear bone growth rate, bone age velocity and imaging studies: Recommended before the initiation of treatment and periodically during treatment beginning 3 to 6 months after the initiation of treatment, diagnostic imaging studies should include x-rays of the left hand and wrist (or the hand and wrist that are not mastered) to
bone age determination, pelvic ultrasound and brain MRI. Serum concentrations of dehydroepiandrosterone, estradiol, follicle-stimulating hormone, human chorionic gonadotropin, hydroxyprogesterone, luteinizing hormone, prolactin and testosterone: recommended before starting treatment to establish the pre-pubertal gonadotropic response
If suppression of gonadal pituitary function does not occur within 6-8 weeks of initiation of LEUPRORELINE therapy and lack of patient consent is ruled out, LEUPRORELINE should be discontinued and a diagnosis of independent gonadotropin sexual precocity should be considered. Other possible causes of sexual precocity include testoxicosis adrenal hyperplasia and hypothalamic or testicular tumors.
Gonadotropin-releasing hormone stimulation tests: Recommended before starting treatment to establish the pre-pubertal gonadotropic response.
Pregnancy tests: Recommended if treatment is not started during menstruation and in patients with abnormal menstrual cycles.
For treatment of endometriosis and metastatic breast cancer:
Pregnancy test: Recommended for potentially reproductive women if treatment is not started during menstruation or in patients with irregular cycles or if the dosage plan is delayed.
Regular injection every 4 weeks of 3.75 mg of LEUPRORELINE; constantly produces a hypogonadotropic amenorrhea. The occurrence of metrorrhagia in the course of treatment is abnormal; this should lead to the verification of plasma estradiol rate and if it is less than 50 pg/ml to the investigation of possible associated organic lesions.
In case of prolonged administration, it is recommended to monitor the bone mass in order to take into account the risk of osteoporosis. Rarely, as with other GnRH agonists, hypercalcemia may appear after treatment in patients with bone metastases.
For treatment of prostatic carcinoma: Prostatic acid plasma phosphatase and/or prostate-specific antigen concentrations and serum testosterone concentrations: are recommended at periodic intervals to monitor response.
Bone scan: Recommended as necessary to monitor response in patients at risk for spinal metastases.
Imaging studies: Intravenous pyelogram, CT scan and/or ultrasound should be used to diagnose or measure patients at risk for obstructive uropathy are especially important during the first few weeks of therapy.
THEY ARE MURDERERS…SO THEY TALK ABOUT NOT BEING ABLE TO HANDLE WOMEN WITH BONE PROBLEMS.
SECONDARY AND ADVERSE REACTIONS:
Some of the adverse effects of LEUPRORELINE are related to hypoestrogenism and hypotestosteronism in men. With long term use the reversibility of clinical hypogonadism produced by LEUPRORELINE has not been established.
There is a risk of increased loss of vertebral trabecular bone density during treatment for endometriosis or for anemia due to uterine leiomyomas, this loss may be irreversible. However, the loss is generally less when the treatment period is limited to 3 months (for fibroids) or 6 months (for endometriosis), except in patients with existing risk factors such as a history of osteoporosis.
Compared to pre-treatment bone density values, bone density values measured by x-ray absorptiometry decreased 3% in patients treated for endometriosis at 6 months; a 12-month measure, 6 months after stopping treatment with LEUPRORELINE showed a 2% decrease in these patients. Also, decreases in bone density have been reported in men who have had orchiectomy or in men treated with a gonadotropin-releasing hormone analogue.
The following adverse side effects have been selected based on their potential clinical significance
The oral active hormone gonadotropin releasing (GnRH) already exists under the name of Ginecrin depot AND OTHERS CHANGE THE NAME TO ORAL AND VUALA …NEW MEDICATION AND EXPOLISHING THE DISEASES
LUPRON IN THE UNITED STATES DEVASTATING EFFECTS
Advanced Prostate Cancer
Exchange of experiences, support and advice for men and with advanced recurrent prostate cancer
“If we have observed a causal effect, then for all the hormone therapies together, we can estimate that compared to what is normal in the general population, about 10 extra ischemic heart disease events per year will occur for every 1,000 prostate cancer patients treated with these drugs,
AND THE STRONGER ASSOCIATIONS OF DISEASES THAT PROMOTE IT, WITHOUT BURDEN OF RESEARCHING.o SIMPLY THE SAME THAT PASSES WITH THE VISANNE THAT HAVE CREATED INTERESTS.
The Solstice study on Endometriosis pain is looking for participants. Please follow the link to see how you can…
a full-scale campaign as you can see…
THESE ARE THE EFFECTS OF THE DRUG ALREADY WARNED SINCE 2011 BY THE AEMPS
Gonadotropin-releasing hormone (GnRH) analogues and risk of depression
Some data suggest that the use of GnRH analogs is associated with an increased risk of depression, which can be severe. The data sheets and package inserts for these drugs in Europe will be updated.
Following the report of a study in Japan describing cases of depression, including suicide, in women with endometriosis treated with GnRH1 analogues, the marketing authorisation holder of leuprorelin carried out an epidemiological study with the GPRD (General Practitioner Research Database). This study showed an increased risk of new cases of depression in endometriosis and prostate cancer patients and an increased risk of suicidal behavior in prostate cancer patients treated with GnRH analogues.
For this reason, the national drug agencies of the European Union decided to evaluate in detail the new available evidence in this respect, taking into account the risk of this type of alterations in patients with prostate cancer or other alterations which constitute the indications of GnRH analogues. On the other hand, it is known that prostate cancer patients treated with GnRH analogues have a higher risk of developing depression or of worsening a pre-existing depression. In addition, there is also a potential risk of behavioral changes and depression in women treated with GnRH analogs for non-neoplastic hormone-dependent conditions.
The active ingredients included in this review have been: buserelin, goserelin, histrelin, leuprorelin, nafarelin and triptorelin.
The data evaluated in this review are from the study conducted with the GPRD database and from a previous safety assessment of leuprorelin based on published data2-11, as well as from spontaneous reporting of suspected adverse reactions.
The results of the study using the GPRD database showed a rate of new cases of depression of 1 to 10 cases per 100 patient-years in men and women treated with GnRH analogues.
In patients with endometriosis treated with GnRH analogues there was an increase in risk of approximately 50% (RR 1.46, 95% CI 1.12-1.89), although the risk observed overlaps with that obtained in unexposed patients (RR 1.38, 95% CI 1.29-1.48).
In this same study, for patients with prostate cancer, a RR of new cases of depression of 1.97 (95% CI 1.86-2.10) was obtained, higher than the increased risk associated with prostate cancer itself (RR 1.45, 95% CI 1.35-1.55). An increased risk of suicidal behavior was observed in these patients treated with GnRH analogues, although the small number of cases and the retrospective and observational character of this study, make these results should be interpreted with caution.
The review of published articles2-12 and cases from spontaneous reporting show that depression and behavioral changes are known risks related to the reduction of estrogen/testosterone levels during treatment with GnRH analogues.
The conclusion of this review has been that the risk of depression and behavioural changes should be consistently included in the data sheets of these drugs. The data sheets and package inserts will be updated to include warnings about the risk of depression, which can be serious, as well as the need to inform the patient and establish timely treatment if necessary. Changes in behaviour and depression shall be included in the section on adverse reactions.