The U.S. Centers for Disease Control and Prevention reports that nearly half of Americans take at least one prescription medication, and nearly 25 percent take three or more. Here in Convington, almost all of us either rely on prescription drugs to keep us healthy or have family members who do.
We rely on the Food and Drug Administration to tell us that a medication is safe, meaning it won’t cause dangerous side effects. Though the FDA requires drug companies to carefully test their products before they can release them to American patients, there are several issues with the system that occasionally allow defective drugs to hit the market.
Are human trials effective?
For each new drug, the FDA requires three rounds of trials on humans. But the number of people in each trial is relatively low. It may not be until the drug is approved and thousands (or millions) of patients start using it that serious side effects become known. The agency also has an Accelerated Approval process that allows the drugmaker to avoid the regular approval process in some cases. There may be even less that we know about drugs that go through Accelerated Approval.
Once a number of patients experience adverse effects from a new medication, a recall is often the next step. The manufacturer may voluntarily issue a recall, or if not, the FDA will order one. In other cases, the FDA will stop short of taking the drug off the market but order that new warnings be added to the labels and patient medication guides.
Taking on the drugmaker
If a defective medication has harmed you, you probably are not alone. It is not unusual for these cases to lead to class action lawsuits, where patients group together to hold a negligent drugmaker accountable.