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Experts Numerous remedies lead years later to unexpected and sometimes serious side effects
When newly developed medicines are approved for use on the open market, users actually assume that taking these medicines is safe. Researchers have now found that nearly a third of all new drugs that have been approved for more than a decade, years later lead to dangerous side effects.
Researchers at the internationally acclaimed Yale University found in their study that nearly one-third of 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).
Medicines are tested for safety before being licensed. Researchers noted that despite this review, many medicines years later can lead to serious health problems or even deaths. (Image: Minerva Studio / fotolia.com) Prescription drugs can lead to dangerous side effects
The results refer to all 222 prescription drugs available from U.S. Pat. Food and Drug Administration from 2001 to 2010 were approved. The researchers looked at potential problems that emerged during routine post-marketing surveillance. For example, the 71 safety-related drugs included agents to treat depression, arthritis, infection, and blood clots, the researchers said. 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 was a surprise to the experts. They included many side effects that were overlooked during the review process, explains author Professor Dr. Joseph Ross of Yale University. However, most security concerns were not serious enough to trigger drug recalls. The results of the study now raise the question of whether drugs are adequately tested before approval.
Some problems are only found in tests on a broad mass of the population
New drugs are tested primarily on hundreds or even thousands of people for their safety and effectiveness. However, new safety concerns are usually only identified when the drug is used by a broader population, says Professor Ross. Overall, U.S. Pat. However, the Food and Drug Administration (FDA) does a good job, the expert adds.
Physicians evaluate online FDA data for their study
Researchers analyzed online FDA data on new drugs and subsequent agency announcements on their side effects. Problems arose on average about four years after approval. We know that new safety concerns are often first identified as soon as a drug is used by a wider population, the doctors explain.
Side effects can even lead to death in some cases
The reported side effects include many serious health problems, including deaths or life-threatening events associated with the drugs, the researchers explain. There were dozens of warnings about less serious potential damage, but three drugs showed serious health damage that could even lead to death, as a side effect, the researchers add.
Examples of medicines and their side effects
Medicines with additional reported side effects included Humira, which is used for arthritis and some other diseases, Abilify, which is used in depression and other mental illnesses, and the drug Pradaxa, a blood thinner, explain the experts.
These drugs had to be taken off the market
There were also drugs that had to be taken off the market. For example, Bextra, an anti-inflammatory drug that can cause heart problems. Raptiva, a psoriasis drug that can cause a rare disease of the nervous system, and Zelnorm, a drug for the treatment of bowel disease, which can also lead to heart problems, the authors report.
Accelerated approval leads to more common side effects
Safety issues are most common with drugs that have been put on the market through so-called accelerated approval, experts point out. The accelerated approval procedure, which is relatively common in the US, should therefore be reconsidered.
It is almost impossible to detect certain side effects before marketing approval
The results of the study raise concerns about whether the newly developed drugs are adequately tested before approval. Since 2011, drugs have been increasingly tested on the basis of studies in a small number of patients. However, even with rigorous clinical trials and a more detailed regulatory review, it may be possible that certain warning signs will not be seen until several years after approval, after the medicine has been widely used, the experts explain. (As)