Hello Ginette 35 meet Risma 17 You are going to make her Blind
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I strongly believe in a women’s right to have control over her reproductive system, but at what cost is this sometimes being achieved. In the case of Ginette 35, which perhaps intentionally, greatly appeals to any teenager with a pimple and sexual curiosity, the cost just seems too high. This being said I don’t think Ginette 35 is wholly to blame in this case. It seems the possibly criminally apathetic doctor and the questionable medical aid scheme restrictions need to share the limelight of guilt with Ginette 35. Without them Ginette 35 would never have been prescribed to Risma in the first place, and certainly her continued use of it, in the face of recognisable symptomatic side effects, contra indicated on the Ginette 35 packaging, would not have occurred.
There is an astounding list of Contra Indications, Side Effects and Special Precautions listed, and in the spirit of understanding, and just in case you are on Ginette 35 here is the whole insert listing, please read it carefully, it’s a shocker.
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GINETTE
SCHEDULING STATUS:
S4
PROPRIETARY NAME:
(and dosage form):
GINETTE
(Tablets)
COMPOSITION:
Each blister strip of 28 tablets contains 21 active hormonal film-coated tablets, each with 0,035 mg ethinyl oestradiol and 2 mg cyproterone acetate, plus 7 inactive non-hormonal tablets.
PHARMACOLOGICAL CLASSIFICATION:
A 21.8.2 Progesterones with oestrogens.
PHARMACOLOGICAL ACTION:
Cyproterone acetate is an androgen antagonist. It possesses progestogenic activity and suppresses the secretion of gonadotropins.
Cyproterone acetate causes the viscosity of the cervical mucous to increase, rendering it hostile to sperm penetration.
Ethinyl oestradiol is a synthetic oestrogen and in combination with cyproterone inhibits ovulation by suppressing the mid-cycle peak of the luteinising hormone released from the pituitary gland as well as the follicle-stimulating hormone.
The combination also alters the endometrium, and this may render the endometrium unfavourable for the implantation of the fertilised ovum. Sebaceous gland activity is suppressed by the cyproterone in the combination.
INDICATIONS:
Oral contraception in women who require anti-androgen therapy. Cyproterone acetate may be used in conjunction with ethinyl oestradiol for the control of idiopathic hirsutism.
For the treatment of severe acne, especially androgen-dependent acne accompanied by inflammation, seborrhoea or the formation of nodes.
CONTRA-INDICATIONS:
Oral contraceptives must not be used during known or suspected pregnancy as it may cause severe harm to the foetus.
A combination oral contraceptive should not be prescribed after a recent evacuation of a hydatidiform mole until urine and plasma gonadotropin concentrations have returned to normal.
Lactation.
Hypersensitivity to any of the ingredients.
Known or suspected breast cancer.
Patients with liver diseases or malignant or wasting diseases.
It should not be given to patients with a history of thrombo-embolic disorders.
This may include myocardial infarction, pulmonary embolism, venous thrombosis and stroke.
Contra-indicated in patients with severe chronic depression and sickle-cell anaemia.
Oral contraceptives are contra-indicated in patients with oestrogen-dependent neoplasms, functional ovarian cysts, the Dubin-Johnson or Rotor syndromes, disorders of lipid metabolism, markedly impaired liver function, cerebrovascular insufficiency, coronary artery disease, thrombophlebitis, deteriorating otosclerosis, a history of pruritus during previous pregnancy, undiagnosed vaginal bleeding, herpes, recurrent cholestatic jaundice or porphyria.
Patients with classical migraine should not use a combination oral contraceptive.
Relative contra-indications (these patient would require medical supervision):
Diabetes mellitus, tetany, hypertension, epilepsy, chorea, multiple sclerosis, renal dysfunction, asthma, mental depression, varicose veins, cardiac dysfunction, gallbladder disease, patients who wear contact lenses and obese patients, or other conditions influenced by fluid retention. The risk benefits should be considered in patients with endometriosis and uterine fibroids.
It is advised that the use of GINETTE be discontinued if any of the following symptoms occur:
1. The onset of migraine or severe headache in a new patient.
2. When there is a gradual or sudden loss of vision or hearing.
3. At the first signs of thrombo-embolic disorders, e.g. pulmonary embolism, cerebrovascular insufficiency, thrombophlebitis, cerebral haemorrhage, retinal thrombosis, coronary or mesenteric thrombosis.
4. Surgery or prolonged bed rest as this may increase the risk of thrombo-embolic episodes. It is recommended that oral contraceptives be discontinued 4 to 6 weeks before major surgery.
5. The product should be discontinued if persistent upper abdominal pain, hepatitis or jaundice develops.
6. If the blood pressure rises markedly the product should be discontinued.
7. Pregnancy.
WARNINGS:
Woman who use oral contraceptives should be strongly advised not to smoke.
Smoking increases the risk of myocardial infarction.
Women smoking more than 15 cigarettes per day have at least a 20% increased risk of serious cardiovascular side-effects. This risk also increases with age and is quite marked in women over 35 years of age.
Not to be used in children and men.
DOSAGE AND DIRECTIONS FOR USE:
Before commencing with GINETTE, an appropriate medical (including gynaecological) examination should be done and the patient's medical history carefully evaluated. Regular medical examinations are recommended during use. Pregnancy should be excluded.
Disorders of the clotting system and family history of thrombo-embolic diseases, especially at a young age, should be excluded.
Androgen-producing tumours or an adrenal enzyme defect should be ruled out before prescribing GINETTE for the treatment of hirsutism.
Additional contraceptive precautions should be taken for the first 14 days of the first cycle or if a tablet is accidentally missed.
Spotting may occur but will usually stop spontaneously.
The patient is advised to consult her doctor if prolonged and persistent bleeding occurs.
The tablet should be taken roughly at the same time every day, not exceeding 24 hours, for maximum effectiveness. The tablet may be taken with a meal to reduce nausea.
Missed doses: Take as soon as possible, that is within the next 12 hours at the latest, but not when it is nearly time for the next dose. Do not double doses. Take the next tablet at the usual time to prevent withdrawal bleeding. Additional non-hormonal contraceptive precaution should be taken.
In the case of diarrhoea or vomiting, additional non-hormonal contraception should be employed in order to prevent pregnancy.
First cycle:
The patient should take the first tablet on the first day of the cycle (the first day of the cycle being the first day of the menstrual bleeding). Thereafter, one tablet should be taken daily, following the sequence of the arrows, at the same time, until all the tablets have been taken. The first tablet should be taken from the silver section (of the calender pack), commencing with the appropriate day as indicated on the strip.
Subsequent cycles:
A new pack should be started the very next day after completing the previous pack, once again starting from the appropriate day within the silver section of the strip. This method should be followed as long as the contraception is desired.
For the treatment of androgen-dependent acne: Dosage as for contraception.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following side-effects may occur:
Breast changes including tenderness, enlargement and secretion.
Changes in menstrual flow (spotting, breakthrough bleeding, amenorrhoea) temporary intermenstrual bleeding, changes in libido, depressive moods, abdominal cramping or bloating and dizziness may occur. Nausea, vomiting, headaches, chloasma, skin pigmentation, vaginal candidiasis, gastro-intestinal irritation, mass gain and peripheral oedema.
Alterations in hair pattern, skin reactions and anaemia have been reported.
Gallbladder obstruction, or hepatitis may occur.
In women using combined oral contraceptives the incidence of circulatory system diseases is significantly higher than those of controls, and the mortality is slightly increased. Cerebrovascular accidents, coronary thrombosis and venous thrombosis are more likely to occur in women over 35 years of age, particularly if they have used contraceptives for 5 years or longer or are cigarette smokers. The incidence is also increased in women who are obese, or if they suffer from hypertension.
The incidence of circulatory system diseases is also higher in women suffering from diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. Thrombosis may be more common in women with blood groups A, B or AB.
Hypertension may occur. Regular blood pressure checks, including a pre-treatment check, are advised. There may be changes in carbohydrate and lipid metabolism.
Liver functions may be impaired. There appear to be an increased incidence of benign liver tumours.
Malignant liver tumours have also been reported. In cases of severe upper abdominal pain, liver enlargement or intra-abdominal haemorrhage, a liver tumour should be excluded.
An increased risk of cervical cancer is reported although other factors may be involved. Intolerance to contact lenses has been reported and vision may deteriorate in myopic patients.
Prolonged amenorrhoea following the use of oral contraceptives may occur. The incidence is in the order of 1% of users. Where oligomenorrhoea or amenorrhoea have occurred in the past, caution is advised.
Special Precautions:
Before hormonal contraceptives are prescribed, the patient should undergo an appropriate medical examination end her medical history should be carefully evaluated. Regular medical examinations should be done during the use of oral contraceptives.
Oral contraceptive failure may occur with the concomitant use of griseofulvin, rifampicin, and other antibiotics, especially aminopenicillins (e.g. Ampicillin, amoxicillin, pivampicillin) and tetracyclines.
Additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for seven days afterwards. Those on long-term antibiotic therapy need only take extra precautions for the first two weeks of the antibiotic therapy. Breakthrough bleeding or spotting are possible signs of diminished contraceptive effectiveness.
Pregnancy have been reported in women taking anti-epileptics (barbiturates, primidone, phenytoin, carbamazepine).
There is evidence that the overall effect of a large supplement of Vitamin C is to convert a low oestrogen oral contraceptive to a high-dose oral contraceptive. Breakthrough bleeding may occur with the withdrawal of high doses of Vitamin C.
The effectiveness of some anticoagulants, antidepressants and antidiabetics may be reduced and the plasma concentration of cyclosporin may be increased with concomitant use. The effectiveness of anti-hypertensives, beta blockers and diuretics may also be reduced and the plasma concentrations of theophylline may be increased during concomitant use. Some laboratory tests may be changed, in particular hormone tests, blood coagulation, thyroid function, glucose tolerance, liver function tests and serum triglycerides.
Under no circumstances should the oral contraception be stopped without having adopted alternative contraception.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.
IDENTIFICATION:
21 yellow film-coated biconvex tablets and 7 larger, white film-coated biconvex non-hormonal tablets.
PRESENTATION:
Carton containing a blister strip containing 21 yellow film-coated biconvex tablets and 7 white film-coated biconvex tablets (calender pack).
STORAGE INSTRUCTIONS:
Store in a cool dry place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
33/21.8.2/0185
NAME AND BUSINESS ADDRESS OF APPLICANT:
Cipla Medpro (Pty)
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 2002.
Cipla-Medpro logo
179NA
IY-1
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“We consider that the risks far outweigh the benefits of Diane 35 for the treatment of acne”-Canadian Health Department 1996
For Risma, who was never allowed a choice, Ginette 35 should never have been prescribed; she did not even have chronic acne. Furthermore was Risma actually put through all the necessary tests that would have indicated any of the numerous contra-indications of the above list? It just has that feeling of another pill blindly thrown at the patient, in the hopes that they are not; the one out of however many statistic that will be negatively effected by that pill. What is worse though, is when Risma did begin to display symptomatic conditions associated with Ginette 35;
2. When there is a gradual or sudden loss of vision or hearing.
3. At the first signs of thrombo-embolic disorders, e.g. pulmonary embolism, cerebrovascular insufficiency, thrombophlebitis, cerebral haemorrhage, retinal thrombosis, coronary or mesenteric thrombosis.
Risma’s doctor did not connect them to Ginette 35 at all, and he gave her antibiotics to treat what he supposed was an eye infection, and she continued taking Ginette 35. One week later she was totally blind, the cause; Retinal Thrombosis or the formation or presence of a blood clot in a blood vessel within the retina. The doctor in question stated that there was a chance, (a chance!) that Risma’s eyesight would return once the toxins worked themselves out of her body. But until that chance of a day, young beautiful Risma on the very cusp of adulthood has been thrown into a pit of darkness.
For the doctor perhaps it was his turn to be unlucky on the roulette table of generalised allopathic doctor prescriptions, Risma was that 1 out of 1666 people who are negatively effected by Ginette and form blood clots that can and have killed other users.
“I would place Diane 35 at the most risky end of the range of combined contraceptives” Dr Jurgen Beckman
So why are doctors doling out such dangerous contraceptives to our teens for whom it has such an obvious appeal? They are effectively condemning every 1666th teenage to possible blindness and death. With a current estimated world population of 6,612,833,325 people of those 293,228,885 are female teens between 15 - 19 years of age, and therefore 176,008 of them could be negatively affected by Ginette 35, and possibly die. Is this an acceptable loss to the pharmaceutical companies and doctors, should any loss at all actually be an acceptable loss, this is not a war, this is our teenagers very lives, and quality of life we are talking about here. Admittedly the pharmaceutical companies have themselves well covered from liability; their detailed insert took care of that. But not so with the doctor, whose implicit care and trust Risma was placed under the moment she walked through his office door. In this case the tragedy was obviously avoidable, and should never had occasion to be so blithely presented to Risma as the only cure all it was touted to be.
We are all unique individuals and this is something that will always trouble allopathic doctors and pharmaceutical companies. We do not fit; can not fit; into neat boxes and classifications in the terms of our medical treatments. The barest glimpse we have had of the true complexity of each persons DNA is proof of this. Beside these unique genetic differences there are always individual unique circumstances that lead a patient to a doctor’s door. It is time for allopathic institutions, and the doctors they turn out; to see this and begin to treat us as the individuals we are. To start looking at our problems holistically and not just instinctively reach for that Russian roulette prescription pad.
I have always been under the impression that an essential holistic part of being an allopathic doctor died out when they stopped making house calls. When a doctors stopped being a part of the family, and truly observing and understanding a family’s whole situation and history, before issuing individual advice and prescriptions. Perhaps the conveyor belt system of a doctor’s office has detached and isolated the average doctor from the real world, real people and their real problems in it. If this is so it is to the detriment of both doctor and patient, and therefore us all. It is an issue that should be addressed; in amongst a horde of others, that together end up treating us like a herd of branded cattle.
What is even worse in this particular case is that any one with online access and a credit card can order Ginette 35 and have it delivered to their doorstep world wide, I got this off a pharmaceutical online shop FAQ, ranked at no 1 on Google Search in a search for Ginette 35;
Q: Do I need to forward a doctor's prescription to supply me with the medications I want to buy?
A: No a prescription is not required to supply any of the medications listed on the website. Most countries worldwide accept the importation of prescription medications into the country. You can import up to a three months supply for personal use.
And if something goes wrong while you are taking the product they sold to you?
Q: Does your company offer medical advice?
A: NO! We are not a medical center nor are we medically qualified. We will not advise or recommend. The information listed on the website is to be used as general information only and is not a substitute for professional medical services or advice. The onus is placed on the customer to be responsible for their own health issues. Please seek the advice of a medical professional if you have any questions regarding suitability etc PRIOR to placing an order.
And so they are not liable just like the pharmaceutical company that supplies them, if anything happens to you while taking Ginette 35. So again it falls to the doctors as their responsibility, though not so, if you bought it without their prescription and counsel. The doctor is the only thin white line between these pharmaceutical companies and their own patients. If they fall victim to the known corruption inflicted by pharmaceutical companies and others like; medical aid schemes and insurance companies, we are statistically doomed before we as patients, even knock on the doctor’s door.
If you take a broader look at oral contraceptives a whole horde of other problems begin to show up statistically. My mother was a dutiful taker of her pill, a teen of the sixties for her it was an inalienable right as a liberated woman. When she was diagnosed at the age of 52, with chronic osteoporosis, her doctor laid the blame squarely on the contraceptive she had been taking for nearly 30 years. In other cases the side effects have included the inability to have children after stopping the pill, sometimes for years and sometimes never again. There are countless more of theses cases and their incidence does seem to be on the rise. They are all high level risks that women have to take on a daily basis to express that unquestionable right of control over their reproductive systems.
With 6 billion of us and growing, we have to have the means to limit our world birth rate, and the pill would seem to be the most reliable way to do that. But again I ask, at what costs is this being achieved, and are we consigning the Risma’s of the world to an atrocious fate with a combination of all of these factors?
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