Clipping of news on Brazilian Culture, Law and Citizenship
31/01/2013
This article was translated by an automatic translation system, and was therefore not reviewed by people.
ANVISA (National Health Surveillance Agency) published a report on Tuesday (29) on the pill Diane 35, warning of the risks of the product to patients with a history of thrombotic processes (clots in the veins or arteries). The document was issued after French drug regulatory agency, the MSNA (L'Agence nationale de sécurité du médicament et des produits de santé), have associated the occurrence of four deaths to the use of the drug.
On Wednesday (30), however, France announced that its generic pill and have suspended the sale - as they come into force in three months. The active ingredient of the product is cyproterone acetate and etinilestradio.
Diane 35 is used in Brazil as a contraceptive and also to control hirsutism (excess hair), acne and polycystic ovaries in women. In France, however, only the counter acne treatment was approved. The health authority considers that there are no studies to confirm the benefit of the product as a contraceptive.
"New data showed that the risk of thromboembolism, including venous thromboembolism, is four times higher in users compared to women who do not treatment," the statement said of MSNA.
The Brazilian agency says that so far has received no reports of health professionals about problems with the product, registered in the country since 2002, and says it is monitoring the case "to assess what measures should be taken."
Sought by UOL on the morning of Wednesday (30), after the agency francesaanunciou discontinuation of the pill, the press office of Anvisa said that for now, the position remains the same.
The report notes that Anvisa the product label in the country now brings warnings regarding the risk of venous or arterial thrombosis. So it should be respected contraindicaçãoi pill for people who have suffered deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, and also for women with signs that may precede these problems, such as angina (chest pain) and transient ischemic attack.
The French drug agency confirmed on Sunday (27), four women who died from deep vein thrombosis related to Diane 35. Other deaths reported were caused by "underlying disease", concluded the health authority.
In recent years, other contraceptives have also entered the radar of regulators, especially drospirenone (Yaz active principle of pills and Yasmin), which has been linked to cases of thrombosis and embolism, causing even some deaths.
Thrombosis is the formation of a blood clot in a vein or artery, blocking blood flow. In deep venous thrombosis, usually the affected vein is lower limbs. The clot can cause swelling and pain. When it disengages and moves into the bloodstream, is called embolism and may cause serious injuries in the brain, lungs or in another area of the body.
What the manufacturer says
Bayer reported that, to date, the contents of the report of the health authorities of France mentioned in press articles was not reported to Bayer Healthcare France. The company notes that Diane 35 is a medication approved by Health Authorities in France for the treatment of acne in women. The same product is approved for different indications in 116 countries in which it is marketed.
"Diane-35 should be prescribed as indicated in the instructions strictly and after a doctor's appointment, following indication and according to label directions. Risk of venous thromboembolism (VTE) is known and clearly mentioned on the product label. How to any drug, prescription Diane 35 is closely monitored. Results of this monitoring are reported to health authorities, following pharmacovigilance regulations, "the statement said.
The company also says it has always worked with health authorities to provide all relevant information about the use and benefit / risk of Diane 35 and will continue to do so.
Source: Uol - news
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This article was translated by an automatic translation system, and was therefore not reviewed by people.