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The law does not require them to put all the information in the prospectus

By on 07/28/2020 0
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Letter sent by Elsa to Maria Antonia:
María Antonia, before I forget, I wanted to comment on a topic, because the other day I saw that you put a news about the interests of the Pharmaceutical Industry…, you see and I’m not paranoid, in Spain the law does not force them to put all the information in the leaflets, but they put a summary of what is convenient for them, and if you want to know all the side effects of a drug, you have to look at the leaflets of Great Britain, United States, France, etc, where they do force them to put everything… (I learned this trick from other medical forums), well to the point, the point is that I already told you that I started with the issue of “weird” muscle and bone pain, insomnia, etc. as a result of the DECAPEPTYL and how it was as if I never recovered from that treatment and my symptoms remained permanently, as if my body had not returned to normal function after that menopause and as a result of the subject I was diagnosed with Fibromyalgia…, and I began to investigate and found that the complete “official” leaflet, which could be downloaded from the laboratory’s website http://www.ipsen.com and which is the file attached to you (it has now disappeared), says the following:

– Undesirable Effects
Endometriosis and uterine fibroid patients

In endometriosis and uterine fibroid patients, adverse effects such as hot flushes, menorrhagia and vaginal dryness, reflect the efficacy of pituitary-ovarian blockade. Cutaneous rash, hair loss, asthenia, headache, weight gain, oedema, arthralgia, myalgia, transient sight disturbances and temporary hypertension may occur. As with any GnRH analogue, a small loss in bone density, specifically trabecular bone density, occurs during six months of DECAPEPTYL SR 3 mg treatment. Clinical data suggest that this loss is reversible.

-Side effects
Endometriosis and patients with uterine fibroids

In endometriosis and patients with uterine fibroids, harmful effects such as hot flashes, menorrhagia and vaginal dryness, which reflect the effectiveness of pituitary-ovarian blockade. Skin rashes, hair loss, asthenia, headache, weight gain, edema, arthralgia, myalgia, transitory visual disturbances and temporary hypertension may occur. As with any GnRH analog, a small loss of bone density, specifically bone mass density, occurs during six months of DECAPEPTYL treatment. SR 3 mg. Clinical data suggest that this loss is reversible.

I’m sure that if you have a leaflet at home you’ll see that it doesn’t say anything about this… (I’ll keep it and if you want I’ll scan it for you…)

I also found this copied from the web: www.lainfertilidad.com, which publishes information about medicines obtained from the General Council of Official Associations of Pharmacists

DAILY DECAPEPTYL
GONADOTROPHIN-RELEASING HORMONE ANALOGUES

ACTION

Synthetic analog of luteinizing hormone-releasing hormone (LH-RH). Chronic administration of triptorelin produces an inhibition of pituitary luteinizing hormone secretion resulting in a reduction of serum testosterone concentrations at the castration level. Initially, in a similar way to other agonists, it temporarily increases the concentrations of gonadal steroids. Treatment with LH-RH analogues, as well as orchidectomy, has not been shown to produce a prolongation of survival, although they do improve the patient’s quality of life.

INDICATIONS

– Advanced [PROSTATE CANCER] with metastasis (Decapeptyl 3.75, Decapeptyl Quarterly 11.25): Treatment is more favourable in patients not previously subjected to other hormonal treatments. – ENDOMETRIOSIS] (Decapeptyl 3.75): Genital and extragenital. The duration of treatment is limited to 6 months. – Uterine [FIBROME] (Decapeptyl 3.75) – [FEMALE INFERTILITY] (Decapeptyl 3.75 and Decapeptyl daily): Complementary treatment associated with gonadotropins (HMG, FSH, HCG) during ovulation induction for in vitro fertilization and embryo transfer. The treatment enables an increase in follicle genesis and follicular recovery. – EARLY PUBERTAINMENT] (Decapeptyl 3.75): start before age 8 in girls, and age 10 in boys.

POSOLOGY

– Prostate carcinoma, im: 3.75 mg/4 weeks or 11.25 mg/3 months – Uterine fibroids: im, 3.75 mg/4 weeks, start treatment during the first five days of the cycle. The duration of treatment depends on the evolution of the fibroids, determined by ultrasound, although it should not be less than 4 months or more than 6 months. A second cycle with this or another LHRH analogue is not recommended. – Endometriosis, uterine fibroids, im: 3.75 mg/4 weeks, within the first 5 days of the cycle The duration of treatment depends on the initial severity and clinical course (usually not less than 4 months and not more than 6 months). It is not recommended to exceed 6 months of treatment with tryptorelin or another LHRH analogue. – Female infertility: 3.75 mg (im) on the 2nd day of the cycle Gonadotropin stimulation should be performed with plasma estrogen levels < 50 pg/ml (normally around day 15 of the cycle). Daily, subcutaneous regimen: Short protocol: 0.1 mg/24 h (sc) from day 2 of the cycle (concurrent with ovarian stimulation) until the day before the planned induction. The average duration of treatment is 10 to 12 days per cycle. Long protocol: 0.1 mg/24 h (sc) from the 2nd day of the cycle. When pituitary desensitization appears (E2 < 50 pg/ml) approximately on day 15 after the start of treatment, stimulation with gonadotropins is begun while continuing with the administration of 0.1 mg until the day before the planned induction. The duration of treatment may be 18 to 25 days per cycle. – Early puberty, im: 3.75 mg/4 weeks. Children under 20 kg, half dose. – Rules for proper administration: quarterly and monthly presentations will be administered by im profunda. Daily presentation by subcutaneous route.

ADVERSE EFFECTS

At the beginning of the treatment, testosterone and estradiol levels are elevated (so their use is associated with antiandrogens: cyproterone, flutamide, etc.) with exacerbation of some of the symptoms, such as bone pain, myalgia, increased urinary difficulty and spinal cord compression. The most characteristic are: -Allergic/Dermatological: occasionally (1-9%): reaction at the injection site (erythema, ecchymosis, pruritus, hardening); alopecia, fever, dry skin. -Cardiovascular: frequently: peripheral oedema (12%); occasionally (<5>5%): nausea, vomiting, constipation, anorexia; occasionally (<5%): gastrointestinal bleeding, diarrhoea, peptic ulcer, taste alterations -Endocrines: very frequently: hot flushes and sensation of heat (40-75%); amenorrhea in 70% of women after the first dose; in treatments for early puberty in girls (30%): occasional metrorrhagia after the first dose; occasionally (1-9%): hypoestrogenism (hot flushes, sweating, headache, depression, mood disorders, reduced libido); sexual impotence, gynecomastia. -Genitourinary: occasionally (1-9%): dysuria, hematuria, vaginitis, vaginal dryness. -Metabolic: occasionally (1-9%): hypercholesterolemia, hypertriglyceridemia. -Neurological: occasionally (5%): dizziness, headache, peripheral neuropathy, paresthesia, weakness of lower limbs. -Osteomuscular: occasionally: increased bone pain (10%) in the initial phase of treatment; myalgia and arthralgia (5%). -Psychological/Psychiatric: occasionally (5%): depression, sedation, asthenia, anxiety, insomnia.

WARNINGS

In patients with prostate cancer it may be useful to perform regular blood testosterone checks, which should never exceed 1 nanogram/ml.

PREGNANCY

Animal studies have not recorded any teratogenic effects. There are no adequate and well-controlled studies in pregnant women. The proportion of malformations in children conceived within IVF protocols where an LHRH agonist was used is 2.7% (general population, 2.1%). Several studies show a higher proportion of premature births in fertilization procedures, which could be related to a higher frequency of multiple pregnancies and the higher number of Caesarean sections recorded in assisted conceptions than in spontaneous pregnancies. The use of LHRH analogues does not increase perinatal mortality, however the incidence of ectopic pregnancies is higher. The use of this drug during pregnancy is only accepted in the absence of safer therapeutic alternatives. It is recommended to exclude pregnancy prior to triptorelin treatment and the use of appropriate and effective non-hormonal contraceptive method during therapy and some time afterwards (except in its use in female infertility). It is also recommended to warn of the potential risk to the fetus or the potential loss of pregnancy in case the patient uses the drug during pregnancy or becomes pregnant during its use.

BREASTFEEDING

It is not known if tryptorelin is excreted with breast milk. Because of the possibility of serious adverse effects in infants, it is recommended that breastfeeding be discontinued or the administration of this drug be avoided.

CONTRAINDICATIONS

– When starting treatment with LH-RH analogues, consideration should be given to the use of an anti-androgen to prevent the effect of the initial increase in serum testosterone. In men: patients with premonitory signs of spinal cord compression. In women: pregnancy.

PRECAUTIONS

– [PROSTATE CANCER], isolated cases of accentuation, usually transitory, of clinical symptoms (bone pain in particular) have been reported. This advises precise clinical observation during the first month of treatment, especially in patients at risk of developing [URETRAL OBSTRUCTION] or spinal cord compression. For the same reasons, the risk of starting this treatment in patients with premonitory signs of spinal cord compression should be assessed. – In the treatment of uterine fibroids and endometriosis, regular administration causes sustained hypogonadotropic amenorrhea. During the first month of treatment, non-hormonal contraceptive treatment should be initiated. With the exception of the first month, the occurrence of metrorrhagia during the course of treatment is not normal. The first menstruation occurs 70 days after the last injection. In case of prolonged treatment, monitoring of bone mass is recommended.

IMPORTANT

The information on medicines is taken from the General Council of the Official Associations of Pharmacists. Under no circumstances should the information published here replace that of your doctor.

Date of publication: 18/08/2004

Look on that same website now appears “summarized”: http://www.lainfertilidad.com/default.asp?seccion=78&idRep=8#

The thing is that I had to go several times to the ER because of the fucking treatment, nobody knew how to say anything and when he went to the gine with the information you do not see the chicken that was mounted, because I have also contacted more people who happened similar things and I have references from foreign studies that relate these treatments with the subsequent appearance in women with endometriosis, fibromyalgia, neurological problems, etc. and even the rheumatologist who diagnosed me with fibromyalgia had also treated another girl with endometriosis with the same root problems of Decapeptyl… And in the United States Lupron (the equivalent) was denounced for these issues and among its side effects it puts… fibromyalgia…

But well, that’s another story I’ll tell you and if you want I’ll give you references, I just know that why aren’t we given full information about the treatments? Why does the General Council of Official Associations of Pharmacists have more information than what appears in the leaflets? What are they hiding from us patients?

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