The Food and Drug Administration is responsible for determining the safety and efficacy of foods, vitamins, cosmetics, medical products, and prescription or over-the-counter pharmaceuticals. Before approving pharmaceutical medications, the FDA examines extensive scientific evidence on all risks, benefits, and safety concerns. After approving medications, the FDA provides information to the public and continues to monitor the safety of each medication. Although prescription medications must pass a rigorous approval process, there is still a risk for serious side effects. In the event of unexpected safety problems, contamination or packaging flaws, the FDA will issue consumer updates, recall notices, and other important information.
The FDA provides a number of consumer information services to help patients stay current with the FDA’s latest updates. Public health advisories and safety alerts are distributed through MedWatch, DailyMed, and Drugs@FDA.
Before the FDA approves a drug for clinical testing, they will review extensive data from studies conducted on lab animals. Pharmaceutical manufacturers, independent laboratories, and research organizations all collect data from animal studies that will be relayed to the FDA for review.
When manufacturers announce a medication has entered the new drug approval process, it means the FDA has reviewed animal studies that deem it safe to conduct clinical trials in the general population. After data from clinical trials is compiled, the FDA will make a ruling whether to approve the drug based on safety concerns and potential health benefits.
The FDA considers an adverse drug reaction to be any undesirable side effect resulting from drug use. Adverse reactions include temporary, life-threatening, and permanent side effects. Mild side effects are often temporary while serious side effects can led to hospitalization, premature death or disability.
Certain prescription medications and classes of pharmaceutical drugs are required by the FDA to be packaged with supplemental warnings to inform patients of the risks for serious side effects and how to avoid adverse reactions. All information included in medication guides has been review by the FDA before publication.
Pharmacies prepare consumer medication information sheets or CMIs to inform patients about important drug information, warnings, and other safety information. CMIs typically include information on how to store the medication and how to identify or treat related side effects.
Package inserts and prescription drug labeling provides crucial information about the drug’s use and how it should be prescribed. Drug labeling is intended for physicians to understand safety risks, potential side effects, and data from clinical trials. Some prescription drug labels also include a brief synopsis intended for patients.
All over-the-counter medications, such as aspirin and allergy medications, include a non-prescription drug label or drug facts section that indicates the drug’s intended use, who it should be given to, how it should be taken, and any possible safety risk.
Boxed warnings or black box warnings are the highest advisory issued by the FDA. When medications have been linked to life-threatening side effects, the FDA requires packaging to be labeled with an additional boxed warning highlighting the potential risks.
After a drug has been approved for the pharmaceutical market, the FDA continues to monitor its safety as well as any reported side effects and safety problems. If necessary, the FDA may require drug companies to modify packaging, manufacturing methods, drug labeling, or patient warnings to reflect data gathered during post-market surveillance.
To monitor the safety of drugs after they enter the market, the FDA operates the adverse event reporting system or AERS, which is a computerized database that records adverse events and side effects reported by hospitals, doctor’s offices, pharmacies, patients, and advocates.
MedWatch is operated by the FDA to relay information between healthcare professionals and the regulatory industry. Through MedWatch, the FDA releases important product updates based on safety concerns and adverse events reported by healthcare providers.
The FDA classifies drug recalls on three levels of severity from Class III to Class I with Class I being the most severe. The FDA may recall drugs from the market due to problems with pharmaceutical ingredients, package seals or the manufacturing process. Class I recalls are only issued when drugs have been linked to life-threatening or fatal reactions.
When drugs have been linked to a disproportionate number of permanent or life-threatening reactions, the FDA may ask the manufacturer to voluntarily withdrawal the drug from the market. If the FDA believes the risks of marketing a drug outweigh the any possible health benefits, they will issue a final recommendation to withdrawal the drug from the market.