adverse effect

Harmful effects of medication.



Drugs: patients may experience side effects, make themselvesComplaints by medicines over the Internet Report: Federal launch new portal to risks earlier entdeckenZur enlargeCorbis
Complaints by medicines over the Internet Report: Federal launch new portal to risks to discover previously
Those who suffer from side effects of a drug can now even his complaints reported to the appropriate regulatory authorities. With a new web portal to test whether risks discover faster and minimize leave.
It rumbles in my stomach, the head seems to spin: Anyone taking a new medication stops, sometimes very closely into what the drug in the body is changing. This attention will now take advantage of two federal agencies to improve the safety of medicines. The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) for vaccines launched on Tuesday the trial period for a new internet portal where patients can now directly report possible side effects of drugs. Until now this was only to physicians, pharmacists and pharmaceutical companies possible.
The aim of the portal is to detect such reports in future faster and easier. Patients and consumers. Via the web access to a simplified reporting form where they can report suspected cases of adverse reactions, without the need for additional confirmation of a physician is required Because the hurdle to visit a doctor because of side effects is relatively high for many patients. This probably lose important information continuously. BfArM writes: "Your message can help us to identify new risk signals in order to take appropriate measures to minimize a risk to human health and can thereby improve the safety of the drug."
The initiative is a proposed change in the law in the European Union, with the purpose of strengthening the importance of patient reporting. International experience has shown, therefore, that the direct report of possible drug side effects by patients can help detect risks early. In Germany also pharmaceutical companies, doctors and pharmacists are required to report suspected cases of adverse drug reactions.
Drugs without clinical trials
The recently published Report 2012 drugs accounted that a third of all new pills is unnecessary. The editor of the report, the emeritus Heidelberg pharmacologist Ulrich Schwabe criticized that today hundreds of medicines in pharmacies, which "had been officially approved without clinical trials." The reason: In Germany, it is only since 1976, a drug law, at least for new drugs required a few studies on safety and efficacy. For the time in question already in the market more than 100,000 drug law did not find any application. Even for these drugs can patient experience now provide additional information.
According BfArM PEI and the personal data of patients will not be stored in accordance with the Privacy Policy. However, it is possible that the authorities put before the deletion of the information feedback to assess the adverse events reported correctly.
An overly detailed introspection can also have negative effects - doctors speak then the so-called nocebo effect, the opposite of the placebo effect: If a physician refers a patient to side effects of medications, can cause the negative expectations of the patient to the fact that he is experiencing the side effects actually.