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.

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.

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.

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.

To avoid last - minute term changes, make sure you have everything in writing from the lender. Read all the contracts carefully before signing. If something seems off, don't be afraid to ask questions.

The most common ones often involve devices where the safety features don't work as expected. For instance, a ventilator that was supposed to have reliable alarms to indicate problems. However, the alarms malfunctioned, and patients were at risk without proper warning. Also, there are cases of medical devices with software glitches. These glitches can cause the device to function erratically, like a drug - delivery pump that delivers the wrong dosage.

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.

There are also cases where the appraised value of the property comes in lower than expected. Let's say you agreed to buy a house for $300,000. But the bank's appraisal says it's only worth $250,000. If you can't come up with the extra $50,000 difference, the mortgage may not be approved. This can be a nightmare especially if you've already made plans based on getting that mortgage and moving into the new home.

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.

The 'no hunger bread' being a 'true FDA horror story' could imply several things. It might be that the product made false claims about reducing hunger. The FDA has strict rules regarding food labeling and health claims. If this bread was making unsubstantiated claims, that's a violation. Also, there could have been problems with the ingredients, like if they were contaminated or not suitable for human consumption. This would be a major issue as it could lead to various health problems for those who ate the bread. The FDA would then have to take action, which might be what makes it a 'horror story' in terms of the company behind the bread facing consequences for their misdeeds.