Kate says her GP initially dismissed her symptoms of leg cramps and breathlessness as anxiety and sent her away with antidepressants. She was told she was suffering from a urine infection and given antibiotics. But two days later she collapsed and was rushed to hospital where she was diagnosed with deep vein thrombosis DVT in both legs, which had travelled to her lungs and caused life-threatening p ulmon ary embolisms. Her legs had swollen up and turned purple, and she also suffered pneumonia, a severe stomach bleed, cysts on her kidneys and an enlarged heart.
When Kate, who lives in Brighton, was first taken into hospital she had been taking Dianette, a hormone treatment prescribed for severe acne in women that also functions as birth control, for her bad skin. Oral contraceptives come with a very small risk of blood clots, and the drug — which is also known as Diane — is associated with a higher risk than other combined pills. Kate, now 28, had been taking the medication on and off for 18 months.
A few months before she was hospitalised, she was prescribed Loestrin 2 — a low oestrogen combined contraceptive pill — despite complaining of leg pain and cramps, which are classic signs of DVT. I was a healthy young 25 year old woman. Then I had lost the ability to walk. After spending a month in hospital, Kate had to move in with her mother and was left needing a wheelchair. Forced to take 18 months off work, she endured a long recovery learning to walk again. Deep vein thrombosis DVT is a blood clot that develops within a deep vein in the body, usually in the leg.
It can cause pain and swelling in the leg and may lead to complications such as pulmonary embolism PE , a serious condition that occurs when a piece of blood clot breaks off into the bloodstream and blocks one of the blood vessels in the lungs. If symptoms do occur they can include:. DVT usually although not always affects one leg. Australian women are still being prescribed a contraceptive pill temporarily banned in France earlier this year, in breach of the advice of the medicines regulator.
An ABC News investigation has found Diane is still routinely prescribed off-label even though it is only approved in Australia as an anti-acne medication. The Therapeutic Goods Administration TGA said it would investigate claims the drug's manufacturer Bayer breached laws that prevent them marketing the drug as a contraceptive. The drug was described as a "contraceptive" on the company's website until this week, when it amended the site following inquiries from the ABC.
Diane was temporarily banned in France in January following a spate of deaths after its regulator found the increased risk of blood clots outweighed its potential benefits. The TGA's advice on the drug has long been that it is only approved for use as a short to medium-term treatment for acne and other hormonal conditions. While it also works as a contraceptive for prescribed patients, it does not have approval for that specific use. The medicine is not listed on the Pharmaceutical Benefits Scheme and sales of the drug are hard to track.
Gold Coast woman Suzanne Lynch developed a blood clot in her lungs after being on Diane for four months. Ms Lynch was prescribed the medication by a doctor who was not her usual general practitioner and failed to pick up a family history of blood clots.
Not-for-profit group National Prescribing Service NPS MedicineWise says it regularly receives calls from women who take the medicine as a contraceptive. NPS pharmacist Sarah Spagnardi says many women started on the pill for acne but stayed on it long-term to prevent pregnancy.
Retail pharmacists support their position, telling the ABC the drug is still routinely stocked on shelves but that sales had dropped off following negative publicity in January.
The active ingredient in Diane is cyproterone with ethinyloestradiol and it is also sold in Australia under the generic names Estelle, Brenda, Juliet and Laila. Published studies indicate the risk of blood clots from Diane and its generics is up to two times higher than other oral contraceptives and four times higher than women not taking the pill at all.
Some doctors are less concerned about risks posed by Diane and its generics, saying there is a higher risk of blood clots during and after pregnancy, which the pill prevents. Obstetrician Steve Robson says doctors need to take a detailed history of patients when prescribing Diane and monitor patients closely. The TGA says its review of the safety information was that the benefits outweighed the risks and it should continue to be available for acne and other androgenisation conditions.
A spokeswoman for Bayer says the medication had a favourable benefit-risk profile when used as directed. South Australian solicitor Tim White is representing women in a class action against the makers of other contraceptives Yaz and Yasmin. Mr White warned doctors who prescribe Diane off-label they could be exposing themselves to potential law suits if patients become ill.
Then you take one pill at the same time every day for 21 consecutive days, which should lead you to the end of the packet. At this point, you must stop taking the treatment for 7 days. This therapeutic pause is necessary and is related to its effect on the menstrual cycle.
After a 7-day break, you should start a new pack and resume your regular schedule. You will experience withdrawal bleeding during your break, which may continue beyond 7 days. You still have to restart your pill-taking schedule after 7 days. Even though Dianette is prescribed as an anti-acne and anti-hirsutism treatment, you are also completely protected from the risk of pregnancy because of its contraceptive effect; therefore, you must not take another hormonal contraception.
If you are relying on this as a contraceptive method, you must remember that oversights put you at risk of getting pregnant. It is, therefore, necessary to adopt certain procedures to minimise this risk if you realise that you have forgotten to take a pill. If you remember within 12 hours after the forgotten pill, you are still protected from a possible pregnancy and should simply take the pill as soon as you remember. Continue to take the pill as usual after this.
If you only remember after 12 hours, its contraceptive efficacy is impaired and cannot be guaranteed for the remainder of the cycle. You must take the missed pill immediately and take the next one at the usual time even if you have the take them very close together, or even at the same time , and also use a non-hormonal contraceptive device condoms, spermicides, diaphragms, cervical caps until your next pack, including during the 7-day break.
Be aware that if you had sex in the 7 days before the missed pill, there is a feasible risk of pregnancy, in which case we advise you to perform a pregnancy test. These provisions also apply in cases of acute diarrhoea and vomiting that occurs within 3 hours after taking a pill, resulting in the same consequences as if you forgot your pill.
Taking Dianette can cause side effects that can either be serious, or frequent and systematic. Also, it varies depending on the woman, as well as how prone they are to developing problems. Firstly, Dianette can be responsible for the onset of migraines and headaches, nausea and vomiting.
This contraceptive and anti-acne treatment can also give you breast pain or tension, especially if it causes them to increase in size. Dianette can also cause bleeding and vaginal discharge during your cycle, which tends to fade and disappear.
There is also the potential to gain or lose weight because of a reduction or increase in your appetite. To avoid this, try to refrain from succumbing to an unusual appetite, or follow a diet until the effects on your hormonal balance have stabilised. It may also have an effect on your libido, again either positively or negatively. Finally, in some rarer cases, you could experience dermatological disorders such as erythema skin rash with lesions whether they are knotty accompanied by hard swellings or multiform in a circle or ring , or hives or rashes red spots.
Women who are intolerant to fructose, glucose and lactose cannot use this pill because it contains these ingredients. Dianette is often prescribed as a second intention after the patient has already tried other treatments for acne beforehand that have not proven effective. Your doctor will do tests and assess your condition in particular by taking your blood pressure as well as conducting a questionnaire about your history and lifestyle, in order to determine whether or not this anti-acne and anti-hirsutism treatment is suitable for you.
In addition, remember that if you are able to use Dianette, it has a very favourable risk-benefit ratio. There is the same low risk of thromboembolism as for 2nd generation pills. There is no need to worry, as this risk is very low. However, Dianette will not be recommended to you if you have any known predisposition, whether hereditary or acquired by declaration and diagnosis of the conditions below, or if your lifestyle exposes you to risks. If you or a family member suffers from venous thromboembolism phlebitis, deep vein thrombosis or pulmonary embolism or arterial thromboembolism stroke, myocardial infarction : thrombosis describes the formation of a blood clot that can obstruct a vein and migrate to the lungs, creating an embolism.
If a member of your family has been diagnosed with one of these disorders, you are not advised to use Dianette. The risk of thrombosis is higher if you have risk factors linked to other diseases, such as cardiovascular disease coronary artery disease—which involves constriction of the coronary arteries—heart valve lesions, or angina or heart issues high blood pressure.
These problems, whether you have a history or currently suffer from them, could also trigger arterial thrombosis. Diabetes should also be monitored because it can cause cardiovascular complications and vascular lesions. Finally, abnormalities related to blood flow in the brain or in the eye may increase the risk of embolic arterial thrombosis.
You will only be prescribed Dianette if you have never experienced one of these antecedents, in order to avoid any risk to your health. All of these predispositions could trigger thrombosis, including those related to blood coagulation resistance to active protein C, or protein C and S deficiency.
Among other predispositions are hyperlipidaemia or excessive levels of different lipid classes in the blood. This concerns people with high cholesterol hypercholesterolemia , including induced dyslipoproteinemia lipoprotein excess in the blood carrying cholesterol.
This also applies to the presence of excess triglycerides in the blood hypertriglyceridemia. Finally, other factors linked to your lifestyle or situation can increase the risk.
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