What are some FDA drug approval horror stories?
Another example is the drug Rezulin. It was approved to treat type 2 diabetes. But Rezulin was linked to liver toxicity, which led to a number of patient deaths. The FDA's approval process was questioned as it seemed that the potential for such a serious side effect was not adequately considered during the approval phase. There were also issues with how the drug's safety was monitored after approval.
What is involved in the process of a novel drug obtaining FDA approval?
The process of a novel drug getting FDA approval is quite rigorous. It includes preclinical studies, submitting an Investigational New Drug application, conducting phase 1, 2, and 3 clinical trials, and then submitting a New Drug Application with comprehensive data. The FDA assesses all this information carefully to ensure the drug's benefits outweigh its risks.
Can you share more details about FDA drug approval horror stories related to new drugs in recent years?
In recent years, a new drug for a neurological disorder got approved. But after it entered the market, there were reports of unexpected psychological side effects like severe depression and suicidal thoughts in some patients. This was not really highlighted during the approval process. It seems that the FDA's assessment of the drug's impact on mental health was not as thorough as it should have been. This has led to concerns among patients and healthcare providers alike about the reliability of the drug approval process.
LSD Drug Horror Stories: What are some real - life LSD drug horror stories?
I knew someone who tried LSD. His experience was a nightmare. He started having a 'bad trip' where he felt like he was falling into an endless void. He couldn't distinguish between what was real and what was the drug - induced hallucination. His heart was racing uncontrollably, and he was sweating profusely. He thought he was going to die. It took him a long time to recover both physically and mentally from that one LSD use.
Can you share some Medical Device FDA Horror Stories?
Sure. One horror story is about a faulty pacemaker. The device had a defect that wasn't detected properly during the FDA approval process. As a result, many patients who received it had irregular heartbeats and some even faced life - threatening situations. It led to a lot of emergency surgeries to remove and replace the pacemakers.
How many novel drug therapies has the FDA approved?
It's hard to give an exact number off the top of my head. You might need to check the FDA's official website or recent reports for the most accurate and up-to-date count.
What are some law FDA success stories?
One success story is the approval of certain life - saving drugs. For example, the approval of drugs for treating rare diseases has been a great achievement. These drugs often have no alternative treatments, and FDA's approval has given hope to patients and their families.
What are some drug test horror stories?
One horror story is when a person had unknowingly taken a cough medicine that contained an ingredient that showed up as a drug on the test. They got in trouble at work even though they were just trying to get better from a cold.
What are some drug addiction horror stories?
One horror story is about a young man who started using drugs in college. He became addicted to heroin. His life spiraled out of control. He lost his friends, dropped out of school, and stole from his family to get money for drugs. Eventually, he ended up in jail, his health in ruins.
What are some 'pcp drug horror stories'?
One horror story is about a person who took PCP and thought they could fly. They climbed onto a rooftop and jumped, resulting in serious injuries. PCP can cause extreme hallucinations and a complete loss of touch with reality, leading people to engage in very dangerous behaviors.
What are some spice drug horror stories?
One horror story is about a young man who used Spice. He started having extreme paranoia. He thought everyone was out to get him and locked himself in a room for days without eating. Eventually, his family had to call the police to break in and get him help.