Once the FDA puts its stamp of approval on a prescription or over-the-counter medication, it’s completely safe to use, right? Wrong. Even after a substance has passed all of the clinical safeguards, adverse reactions may still show up later. These should be reported to the FDA, and a defective drug injury lawyer should be called.
Understanding the Approval Process
In most cases, it takes several years for drugs to be approved by the FDA. In fact, every new medication, no matter its intended purpose, must undergo rigorous testing to ensure its efficacy and safety.
- Initial Steps. Before any medicine is ready for human use, the chemicals and ingredients must pass a full animal testing phase. Toxicity levels and potential side effects are noted. While animals are different from humans, this testing provides some insight on what should be expected. After animal testing is complete, the drug company may submit an application to FDA. The FDA then reviews all applications, looking for any indication that the drug may be harmful to humans.
- Clinical Testing. The next step involves three phases of clinical testing with human volunteers. Each phase serves a distinct purpose, and each phase must be completed and approved before going on to the next one.
- Phase One. This is the smallest phase, with only a few dozen participants. The goal is to see whether the drug is properly metabolized by humans. Side effects are also noted.
- Phase Two. This phase involves several hundred patients. The goal is to determine the long-term efficacy of the drug, along with noting all side effects, no matter how minor. Trials often use a double blind study, where some patients are given the drug, while others are presented with a placebo. Results are monitored from both groups.
- Phase Three. When a drug reaches this phase, drug manufacturers are optimistic that it will ultimately be approved. Thousands of patients are given the drug. The manufacturer may try different dosage combinations to determine whether there is a difference with efficacy.
- Final Review. After all clinical testing is finished, the FDA will review the results. An application is submitted, showing clinical findings and side effects. If the FDA believes that the beneficial results outweigh the side effects, the medication will most likely be approved.
Not All Approved Medications Are Safe
Even after years of trials, some medications that are approved by the FDA eventually are determined to be unsafe. Patients may experience dangerous side effects years after taking the medication, while others may become permanently disabled or even die as a result of the medication.
When It’s Time to Hire an Attorney
If you are dealing with health problems as a result of taking a medication you thought was safe, you need to hire a lawyer with experience in FDA drug injuries. A lawyer will gather evidence to prove that the medication is to blame for your distress. You have the right to be compensated for any injuries you sustained after taking an FDA approved pharmaceutical.