Experts: Many medicines lead to unexpected and sometimes severe side effects years later

Doctors check the safety of already approved medication
When newly developed drugs are approved for use on the open market, users actually assume that taking these drugs is safe. But researchers have now found that almost a third of all new drugs that have been approved for over a decade lead to dangerous side effects years later.

The scientists at the internationally recognized Yale University found in their investigation that almost a third of the newly approved drugs lead to sometimes life-threatening side effects or complications years later. The experts published the results of their study in the internationally recognized medical journal "Journal of the American Medical Association" (JAMA).

222 prescription drugs can lead to dangerous side effects
The results refer to all 222 prescription drugs released by the U.S. Food and Drug Administration were approved from 2001 through 2010. The researchers examined potential problems that arose during routine post-market surveillance. The 71 drugs with safety risks also included agents for the treatment of depression, arthritis, infections and blood clots, for example, the scientists explain. The drugs can cause severe skin reactions, liver damage, cancer, and even death.

Are new drugs adequately tested?
A large percentage of the problems identified came as a surprise to the experts. They included many side effects that were overlooked during the review process, explains author Professor Dr. Joseph Ross from Yale University. However, most of the safety concerns were not serious enough to trigger drug recalls. The results of the study now lead to the question of whether drugs are adequately tested before approval.

Some problems are only found when tested on a wide range of the population
New drugs are primarily tested on hundreds or possibly thousands of people for their safety and effectiveness. However, new safety concerns are usually not identified until the drug is used by a broader population, says Professor Ross. Overall, the U.S. Food and Drug Administration (FDA) does a good job, however, the expert adds.

Doctors evaluate online FDA data for their study
The researchers analyzed online FDA data about new drugs and later agency announcements about their side effects. Problems averaged approximately four years after approval. We know that new safety concerns are often only identified once a drug is used by a broader population, the doctors explain.

Side effects can even lead to death in some cases
Side effects identified include many serious health problems, including deaths or life-threatening events related to the medication, the scientists explain. There have been dozens of warnings about less serious potential harm, but three drugs showed serious health effects that could even result in death as a side effect, the researchers add.

Examples of drugs and their side effects
Medicines with additional side effects identified were, for example, Humira, which is used for arthritis and some other diseases, Abilify, which is used for depression and other mental illnesses, and the drug Pradaxa, a blood thinner, the experts explain.

These drugs had to be withdrawn from the market
There were also medications that had to be withdrawn from the market. For example, Bextra, an anti-inflammatory drug that can lead to heart problems. The authors report Raptiva, a psoriasis drug that can cause a rare nervous system disease, and Zelnorm, a drug for the treatment of intestinal diseases, which can also lead to heart problems.

Accelerated approval leads to more common side effects
Experts emphasize that safety problems most frequently occur with medicines that have been brought onto the market by a so-called accelerated approval. The accelerated approval process, which is used relatively frequently in the United States, should therefore be reconsidered.

It is almost impossible to identify certain side effects before marketing approval
The results of the study raise concerns about whether the newly developed drugs will be adequately tested before approval is granted. Since 2011, drugs have increasingly been tested based on studies on a small number of patients. Even with rigorous clinical studies and a more precise regulatory review, it may be possible that certain warning signals can only be recognized a few years after approval, after the medicine has been in widespread use, the experts explain. (as)

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