The Food and Drug Administration (FDA) has strict standards about prescription drugs. However, many remain available to consumers for years before dangerous side effects finally result in their recall.
What kind of drugs are most often categorized as defective and how does the FDA react?
A little background
The FDA sets policies to ensure consumer safety with respect to regulated drugs. However, the process for enforcement and the removal of a drug from the market, if necessary, can take years. In the meantime, the FDA may make an announcement regarding the risks of taking a certain prescription drug and by adding new warnings to the drug’s label. Patients might continue to take a drug that has potentially dangerous side effects.
Defective prescription drugs
Among the prescription drugs commonly defective are:
- Type 2 diabetes drugs: Some show links to heart attacks and other cardiovascular problems. Actos and Avandia are among the defective drugs in this category.
- Antidepressants: Used for decades in treating depression, these drugs may result in birth defects or suicide. Examples of problematic drugs are Prozac and Zoloft.
- Antibiotics: Both adults and children take antibiotics, but Zithromax, used to treat bacterial infections, may cause heart problems. The FDA has issued a warning about this kind of side effect.
FDA follow-up
In response to defective prescription drugs, the FDA will conduct interviews, demand additional drug trials, add warnings to drug labels, contact doctors about the issues and write reports. The FDA might also require that patients who experience adverse side effects enroll in drug programs. The mislabeling of a drug and the resulting serious side effects are among the most common reasons for lawsuits pertaining to defective drugs.