European Medicines Agency: Long-term risks of speaking prematurely
The European Medicines Agency (EMA) announced this week that its specialists are investigating the presence of impurities in Zhejiang Huahai Pharmaceuticals, active substance of valsartan. – N-nitrosodimethylamine (NDMA) – clbadified as a potential carcinogen. Based on laboratory findings, the long-term use of NDMA may be a cause of oncological disease, but it is indicated that the long-term risk is too early to talk about. The conditions for the emergence of NDMA are thought to have appeared after the changes introduced in 2012.
In the past two weeks, national authorities withdrew from the marketing of all drugs containing valsartan produced by Zhejiang Huahai. This means that they will no longer be in pharmacies of the Member States of the European Union.
Inappropriate medicines were not flooded by Lithuania, they had to be removed from the trade and removed from the list of reimbursable medicines. Eldas Stropus, director of the department of medicines of the Ministry of Health (VLK), said that since July 14, 2009, the Department of Medicines of the Ministry of Health, Evaldas Stropus, has lost 26 drugs against valsartan in the 39 former second quarter of this year. The updated price list contains 17 pharmaceutical packs containing safe and high quality use of valsartan. Among these manufacturers, there are several pharmaceutical companies: Teva, KRKA, Sandoz, Novartis and SIA Ingen Pharma. According to E. Stropaus, these cleared medications will be given to patients in pharmacies with a new prescription from a doctor.
VLK recommends to doctors not to forget the aspect "pharmacoeconomic"
Part of the drug was withdrawn from the market, VLK sent information to medical institutions with recommendations on what drugs should be given, indicating that the active ingredient contained in them should also be the group of red, but pointed out that it is proposed to be "no more expensive than valsartan, for example. or telmisartan. "
"All medicines delivered on the Lithuanian market are safe, which guarantees that the procedure for the registration of medicines is carried out by the Ministry of Health of the Republic of Lithuania. maintained by the National Agency for the Control of Drugs.All drugs on the reimbursement list are also safe and authorized for use by patients.VLK recommends that the patient always articulates on the appointment or replacement of the patient.
It is suggested to use the cheapest drugs, but it is suggested to change the treatment to other drugs whose price is comparable to the price of drugs currently on the market. The doctor should always consider the drug as a drug from a pharmacological point of view, if the patient's illness can be treated with a drug less c expensive, so this drug should be the first choice, "said E. Strappus, a publisher
. The representative of the VLK indicated that their current quantity is sufficient and that if the suppliers can no longer supply them, according to the procedure established by the legal acts, will include a producer who is not currently compensated Price of drugs, drugs.
President of the Lithuanian Association of the Heart: the scandal has brought to light some important aspects
President of the Lithuanian Association of Heart, cardiologist prof. Raimondas Kubilius believes that some patients could have avoided this situation if they had the opportunity to choose the remedies to buy.
"Valsartan is still in 2010. Has become the best antihyperlipidemic product in the world, so I exceeded the record limit of $ 6 billion.On the other hand, three decades ago, when this The molecule's active ingredient has been developed and, in clinical practice, has proven its effectiveness and safety, there was no doubt that it would immediately become a target for generic drug manufacturers. "DELFI / Šarūnas Mažeika
This scandal has highlighted important aspects.One is that in the world due to the ongoing globalization, many pharmaceutical companies from a manufacturer, in this case the China, buy the same active ingredients, which are given in pharmacy form, packaged and issued under their own brand.Thus, the consumer has the same substance content, despite the fact that it is sold by different pharmace companies generic drugs.
Secondly, this story perfectly reflects the pbadionate debate between patients and public authorities about us at the beginning of the year, namely whether the patient should have the right to choose an ethical drug if he accepts a premium higher or to make the same choices only the cheapest on the market? Today, it is clear that patients will not experience these experiences that will last until July 6, "explains the professor
. According to a cardiologist, this drug, found in drugs containing valsartan, attracted attention 20 years ago. Chemists have discovered that the type of impurities found, nitrosamines, are found in various industrial production chains, while smoked meat products, fish, beer and tobacco products are harmless and extremely low, but they are not considered to be present in the body.
"N-Nitrosodimethylamine (NDMA) is known to be an organic substance that has been used as a carcinogen in early laboratory experiments, and NDMA is characterized by high toxicity and potentially carcinogenic mutagenic effects. that high amounts of this substance in rodents cause liver scars (fibrosis), and in the long-term effects of low doses and liver cancer.It is hypothesized that this substance can cause cancer in humans, although this is not definitively proven, "says the doctor.
The President of the Lithuanian Heart Association is inclined to believe that there will be no carcinogenic effects or adverse effects on liver patients.
"As I mentioned, although this compound is recognized as a carcinogen, it has not been shown. In general, it must be admitted that the regulation of the production, distribution and control of medicines is particularly strict in all countries, and that such stories are extremely rare, perhaps even unprecedented. Significantly, more cases occur when the product is withdrawn from the market because of unproven safety and adverse effects on the patient, "says Kubilius.
LUP: a very rare case
Deputy Chief Zydrūnas Martynas says that the situation when drugs are canceled not only from Lithuania but also in the EU markets and d & # 39; other countries are very rare. The IWT spokesperson also explained that manufacturers are responsible for quality control of drugs.
"The supply of drugs in EU countries is regulated unanimously by guidelines and regulations.If you are asked if the drugs are controlled before you To enter the Lithuanian market (or any other EU country), the quality control of the drugs and the so-called marketing are carried out by the manufacturer of the drug. the Republic of Lithuania states that state control and release are only mandatory for immune and blood products.
Monitoring of drugs on the Lithuanian market is ensured by examination of drugs included in the IOP annual quality control program. The selection in the program is carried out in accordance with the principles of risk badessment (developed according to the directives of the Quality and Health Care Directorate of the Council of Europe), without distinction between generics and original preparations ", said Martinėnas magazine, Internet magazine
Martynas said that information on the poor quality of drugs containing valsartan are available on websites, but also on television (LRT, TV3, LNK), on the radio (LRT), to health facilities and pharmacies.
be able to choose a treatment
It is clear that the main people in this situation are the patients who have been treated with these drugs. Augustinienė, president of the Council of Representatives of Lithuanian patient organizations, look at the list of drugs that are now cleared for patients involves a disappointment – there is nothing to choose
"This case shows that in these cheap drugs, even though the Ministry of Health still explains the importance of the active ingredient, but not the other ingredients, it turns out very important. This case has shown that the active substance is the same, but one of the ingredients is the cancer that causes it. Perhaps the European Medicines Agency is also worrying unnecessarily about removing them. I think that's the first case of this list, when it happened, but maybe there are more.
If you look at the list of reimbursement drugs, the arm is really fluctuating. People are being denied the opportunity to treat better, more effective, newer drugs, while leaving cheap drugs alone. What about the cost of 2-3 euros and the bonus of only one cent? A person is deprived of the right to receive adequate and effective treatment. Doctors can no longer give patients the medications that they have been able to treat so far, because the drugs probably have not lowered their prices to zero, simply disappear from the list and people have to change of treatment ", – says V. Augustinienė in the DELFI.
The most difficult treatment is to coordinate at the same time chronic people with several different drugs, and if any of them changes they can fall into all their food.
Pharmaceutical products accepted and replaced free of charge
Representatives of the Ministry of Health and the National Drug Control Agency (LPIC) have previously indicated that due to the poor quality of return of drugs and their replacement with other safe drugs, has the right to prescribe prescription drugs in some cases.
Representatives from three pharmacies confirmed that many people are asking for a change in their medication or just asking for advice. All interlocutors indicated that their pharmacies take substandard quality wadding and replace it with others, but not with the same ones.
Asva Valatkeviciene, head of "Eurovision" communication, said residents could bring a free, dangerous medicine to any Eurovision pharmacy. take other drug manufacturers with active ingredients manufactured safely. According to her, since the end of last week, more than 300 people have requested such a service.
"We are very interested in people who call and find out which drugs containing valsartan are safe and potentially dangerous. A number of types of drugs of this type are withdrawn from the market, but there are also drugs that are produced safely. Our information specialists and our pharmacists constantly advise people, helping them to differentiate themselves. When pharmacies arrive with a dangerous drug, they choose the appropriate safe medication from another manufacturer and issue it for free, "said A. Valatkeviciene.
In all "Amber" pharmacies, drugs are also exchanged for free regardless of which pharmacy they purchased. There is no need for a prescription to change drugs.
"<...> We have taken steps to ensure that patients can continue their treatment with safe medications July 13" We are removing potentially dangerous drugs from all our online pharmacies, and instead of safe alternatives – drugs with the same active ingredients produced by other manufacturers, "says Irena Tėvelienė, marketing director of Amber Pharmacy.Lina Skersytė, department head, said that nearly three hundred patients have requested In these pharmacies, a recipe is needed
"We accept all packets brought to the pharmacy for the valid course of treatment and are purchased at Camelia pharmacies and are replaced by the same amount of usable drugs free of charge. . A patient who wants to change medication must submit a document certifying the appointment of a doctor at the pharmacy. We plan to comply with such a drug replacement policy by July 31, so we invite patients to visit Camelia Pharmacy and deal with this problem to exchange drugs. "- L. Skersytė commented on the situation.
Withdrawn from Marketing
DELFI recalls that valsartan is not the name of the drug but the active ingredient. There are many drugs containing valsartan, but they do not all produce the active ingredient they need for their products.
The company that manufactured this active ingredient has administered valsartan to many generic drug companies.
The IWT report indicated that the appearance of impurities was supposed to be due to changes in the way of production of the active substance
The list of these drugs published by the IWT IUCN was suspected of causing suspicion of specialists, is 38, and the trade in these drugs has been canceled in 22 countries. Later, the United States joined countries that refused to receive drugs with low quality valsartan.
For a list of canceled medicines from the Lithuanian market, see:
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