Complications, combinations, abuse

In the US, the serious side effects of drugs take too

No effect without side effect. But that in the years between 1998 and 2005 has more than doubled the number of serious forelegal drug use, even the US experts surprise itself. Thomas Moore and his colleagues from the Institute for Safe Pharmaceutical Application ISPM in Pennsylvania examined the trap reported to the FDA in an eight-year-old period. The heavy side effects took around 2.6 times, such a deadly output by a factor of 2.7. In absolute numbers: 1998 were still 34.966 serious complications reported, 2005 already 89.842. The deadly trap increased from 5.519 to 15.107.

Study Manager Moore: "This is the first study who asks’ we make progress or rucks in the safety of prescription drugs?’And I mean, the inevitable conclusion is that we make jerking steps."Although outpatient prescriptions increased from 2.7 to 3.8 billion in the period, the number of figures reported four times so strong.

The spokeswoman of the FDA, Sandy Walsh, further appreciation needs look at the study, points to the "increased public attention regarding drug safety" and the improved reporting system. The scientists, on the other hand, are sure that not the more common report has caused the increase in numbers, because only almost 20 percent were reported directly to the FDA. You can see other causes.

Old acquaintance

A group of 51 medications recognized by the accomplished medicines is responsible for half of all reported traps. These are two-thirds of active ingredients that have long been on the market. So the heavy trap is quadrupled at insulin. Why is unclear. Moore suspects a "divoretic treatment" of type 2 diabetes.

The experts just want to see part of the rise on poorly advanced active ingredients. They drove a quarter of the increase in the amplifier use of medicine therapies back.

In addition, there were rough problems with morphine, hydrocodone and other opioids such as fentanyl and oxycodon. This active ingredient from the group of opioid analgesics is also increasingly used in Germany because one hopes for less side effects than other painkillers of the opioid class.

It is believed that improper use and combination with other medications, but above all the abuse by opiate-contacting to the auspicious increase in the reported complications. Survaged is also a connection to the lack of explanation of patients by doctors.

No kausalitat?

The authors of the study, which appeared in September ie of the Archives of Internal Medicine, drove another 15 percent of the increase in the side effects on biotechnological products, which only has launched in recent years. Among them are immunomodulators for the cancer therapy and interferons used in multiple sclerosis (interferon alpha) and hepatitis-C (interferon beta).

Despite the alarming data, the authors warn against premature conclusions. The submission of a report at the FDA was not justified by causality. In addition, one had focused on the primary-suspicious drug, and though averaging two drugs per incident had been mentioned. In a quarter of the trap, even funf or more prescribed active ingredients had played a role.

In Europe, the European pharmaceutical agency collects the submitted data on side effects. Official annual reports do not exist, however, it became known that the published forelection from the EU member states between 2003 (15017) and 2005 (42120) almost tripled. However, there is no consumer nor physician access to the database. This should first be like the agency "in the coming years" change.

Until then, the individual Lander Dafur are scaled to capture the risks that are reported by doctors, manufacturers and patients. In Germany, the Federal Institute for Medicines and Medical Devices (BfArM) evaluates these reports. In addition to the statement work of the doctors, the curiosity of the patients is still in demand. But only about 70 percent of patients read the leaflet of their medicine – and only the half of them understands them.