North Carolina Dangerous Drug Attorney

Many people throughout the U.S. take prescription or over-the-counter medications to treat certain health conditions and symptoms. While many drugs are designed to provide recognizable health benefits, some patients experience adverse side effects after taking medication. When a drug causes harm, drug makers can be held legally responsible for the resulting damages—even if the drug has been previously approved for use by the U.S. Food and Drug Administration (FDA). Patients who have been injured by dangerous drugs are filing lawsuits against the drug makers with the assistance of a North Carolina dangerous drug attorney.

The Drug Approval Process

Before a new prescription drug can enter the marketplace and be prescribed to patients by a medical professional, it must undergo a rigorous testing and evaluation process. According to the FDA, the first step a drug manufacturer must take is to receive approval to perform animal tests to determine if the medication will be safe enough for humans to use. After animal testing is performed, the manufacturer can then perform clinical trials, which are monitored by the FDA, and submit a New Drug Application to the FDA’s Center for Drug Evaluation and Research (CRER) if the trials are successful.

Once it is determined by the CRER that the new drug has more benefits than risks, it can then enter the health care marketplace. However, just because a drug enters the marketplace does not mean that the FDA discontinues its monitoring of the medication. After a drug is permitted to enter the marketplace and be sold, the FDA uses a number of strategies to monitor the safety and effectiveness of the medication.

Why Drug Approval Data is Limited

Despite the FDA’s comprehensive testing and approval process for new drugs, the safety data they collect during these processes is still limited for a number of reasons, including:

• When drug manufacturers performs clinical trials, they are only able to test a group of people that is substantially smaller than the total number of people who will eventually take the drug. As a result, it can be difficult for companies to determine if rare side effects will occur.
• While the data from a drug’s clinic trials are assessed by a team of professionals, it is extremely difficult to determine exactly which bad reactions can occur when the drug is used.
• Many prescription drugs are taken by sick people who take a number of medications, making it hard to tell how every individual will react to a certain medication.

Additionally, since adverse drug-related events are reported on a voluntary basis, many serious drug reactions go unreported to the FDA, allowing some harmful medications to remain in circulation.