About one-third of medications approved by U.S. Food and Drug Administration have safety issues. The result has been found after the researchers reviewed 222 FDA-approved drugs from 2001 until 2010.
In the study, 71 drugs had postmarket safety risks, in which FDA completely banned three drugs. Additionally, the company sent out 59 pieces of safety communications and instilled 61 box warnings.
The drugs that posed most of the risks following the approval were biologics, according to Everyday Health; these medications are made up from living organisms. Other drugs that face safety issues include psychiatric disease medications, drugs approved with an impending deadline for review, and drugs from FDA's accelerated approval program.
In the FDA's Accelerated Approval Program, drugs were produced for instant treatments for serious conditions with unfulfilled medical needs. Some of the recent drugs approved by FDA here are the treatments for urothelial carcinoma - for urinary system cancer. The findings indicate that rushed process for drug approval plays a big part in causing the problem.
The maker of drugs should present an application to FDA regarding the procedures for testing and chemical compositions upon developing the drug. FDA will test the toxicity and efficacy on animal species, and review all the data before approving the medication on humans.
Then, manufacturers will run three phases of clinical trials. First, they will focus on the side effects and safety of the drug to 20-80 participants. After that, they will review the efficacy of the drug to identify if it works on a particular condition before testing it again on hundred participants.
In the last phase, manufacturers will recruit thousands of people to merge the effectiveness and safety of the drug, and will analyze the dose and interactions of the drug to other medications.
FDA will review all of the medical labelings, then records a New Drug Application to the manufacturer to assess the application and research, and then on the safety and effectiveness of the drug.
For the last step, FDA inspects the facilities of the manufacturer before the proposed treatment will be either approved or denied. These submissions are all evaluated by the FDA's team including chemists, physicians, pharmacologists, and statisticians.
However, despite the crucial process, there are still drugs found to have deadly consequences. According to the report from NPR, Vioxx - a drug that reduces gastrointestinal pain - has been prescribed for approximately 20 million people before being pulled out of markets. The medication has been found to cause several heart problems like heart attacks leading to strokes.