Online database shows side effects of drugs

Database: Massive drug side effects

04/24/2013

As we have reported many times, medications can have serious side effects: whether liver damage from painkillers, an increased risk of abortion through anti-inflammatory drugs or pulmonary embolism by taking birth control pills - the list is long and whenever a new one „Drugs scandal“ Once again, the question arises as to whether this could not have been prevented and why medicines with such severe risks should even be marketed.

Federal Institute for Drugs and Medical Devices puts database on the Internet
But now there is a new opportunity for patients to get valuable information about medications and possible side effects, because the Federal Institute for Drugs and Medical Devices (BfArM) is now publishing its database for adverse drug reactions (ADRs) via the Internet.

Here, according to the BfArM since 1995, all „reported suspected cases of adverse drug reactions (ADRs) from Germany in connection with the use of medicinal products (synonym: "Suspected cases of adverse reactions") listed“ - which does not mean, however, that this causal relationship with the drug actually exists. Therefore, in the next step, the negative effects of medicines reported annually by physicians are checked for actual side effects in the next step - the Federal Institute for Drugs and Medical Devices finds the negative effects after a thorough examination of the data for „real“, Finally follows the assessment or the recall of the corresponding product.

However, free access to raw data could also cause confusion
The database is freely accessible without limit, but whether this in the current form rather confusion rather than support, remains to be seen first. Because the data are not straightforward for medical laymen to understand, so what it means for yourself, for example, if in five patients within a year after the intake of drug X dizziness occurred, remains questionable at first. If, on the other hand, there is the information that there have been 20 cases of dizziness in females between the ages of 20 and 40 over a period of 10 years, then the patient may be more likely to get a full picture of the risks of the drug.

BfArM tries to avoid misinterpretations through education
So there is a certain risk here that the data could be misinterpreted and might cause panic rather than reassurance. The BfArM is obviously aware of this danger, because if you want to use the database, you will first be confronted with a multitude of information, hints and warnings about the search, which must first be accepted before the page can go any further. Nevertheless, it is reasonable to assume that free access to the data will soon lead to much discussion and criticism, especially because, for example, pharmaceutical opponents could easily use the data in their favor.

Discovery of rare side effects through patient reports
But despite the risk of misinterpretation, the free accessibility of data in addition to education also offers great potential in terms of the discovery of massive side effects that may be so rare that they are not even mentioned on the usual package leaflet. It is all the more important that negative drug effects are not only researched, but can also be reported by patients at the same time - so in autumn a corresponding Internet portal will be opened, in which patients can quickly and easily report changes and side effects of drugs.

Registration system for patients since 2012 in the test phase
Since October 2012, the reporting system for patients and consumers is already in the test phase. Heilpraxisnet.de reported that at that time the Federal Institute for Drugs and Medical Devices, together with the Paul Ehrlich Institute (PEI) for vaccines, had launched the portal www.verbraucher-uaw.pei.de, which has since been used to transmit side effects to the federal authorities depending on the responsibility, to the BfArM or the Paul-Ehrlich-Institut. (No)