Frequently Asked Questions
Medicines are an important part of everyday life, making it possible for millions of Americans to lead more productive, healthier lives. Fortunately, today there are more than 10,000 prescription medicines available to patients—each of them holding potential benefits and risks.
The purpose of this document is to answer the most frequently asked questions about drug safety.
Are prescription drugs safe?
There are more than 3.6 billion prescriptions written per year in the U.S. and for the overwhelming majority of patients, those medicines have proven to be safe and effective.3 According to the Food and Drug Administration (FDA), about 97% of the drugs it has approved over the past two decades are still on the market and considered safe.4 America’s pharmaceutical companies, while pleased with this performance, continue to strive for improvements to this safety record.
How is drug safety established?
Drug safety is established incrementally through all stages of the development process. It is assessed early in the process through a series of laboratory tests, animal tests, and then with very small numbers of volunteer patients. Only after it’s clear that a drug is safe for people will it be tested in larger numbers of individuals in carefully controlled, monitored studies known as “clinical trials” to assess both safety and efficacy. These studies, which are evaluated by the FDA and overseen by independent review boards, often take in total 10-15 years to complete.
How is drug safety monitored?
Pharmaceutical companies, the FDA, health care providers and patients all play important roles in monitoring drug safety. Once a new medicine is approved, the manufacturer is required to file safety reports with FDA every three months for three years, and then annually for as long as the drug is marketed. Serious and unexpected adverse events must be reported to FDA within 15 days.
In addition, FDA may request a series of long-term, follow-up studies on the medicine. The companies have dedicated teams of experienced physicians and scientists whose job is to collect and analyze safety data on a daily basis, and to immediately report any potential problems to government authorities.
FDA has a team of physicians and analysts that monitors these reports closely, gathers data from a variety of sources and looks for evidence of an unsafe product or potential safety concern. Approximately half of the Agency’s drug review resources are dedicated to evaluating both pre- and post-market drug safety.
Physicians, nurses, and other providers are on the front-line of drug safety; they are often the first to learn of a potential problem with a medicine and are obligated to report issues or concerns promptly to the FDA.
Finally, patients have a critical role to play—sometimes safety issues are not discovered in the clinical trials process but become evident once a larger number of people begin taking a drug. That is why it is imperative for patients to understand what the potential risks are of their drug, to recognize side effects, and to report them to their physician or FDA immediately.
If drugs are tested so carefully during the clinical trials phase, why do we need to monitor them so closely after they receive FDA approval?
No drug is 100% safe and effective for all patients. Every drug, whether it is over-the-counter or prescription, carries some risks, or potential side effects, and sometimes these side effects don’t become known until after the medicine has been made available to the general patient population. Therefore, manufacturers and FDA collaborate on long-term follow-up studies and physicians, nurses, and patients are urged to report any unusual side effect experienced while taking medication.
What is the role of pharmaceutical companies in ensuring drugs safety?
The pharmaceutical industry has two major roles in managing the safety of medicines:
- To collect, investigate and proactively evaluate information relating to side effects of medicines during the clinical trials phase.
- To vigorously monitor health outcomes and report to the FDA any and all evidence of possible “adverse events,” or negative side effects, that some patients experience once the medicine is made available to the general patient population.
What is the FDA’s role?
The FDA serves as a consumer watchdog—it makes sure that safe and effective drugs are available to improve the health of patients who need them. The FDA evaluates new drugs before they can be sold and ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks. The FDA’s review of new drug applications not only prevents unsafe drugs from entering the market, but it provides doctors and patients with the information they need to use medicines wisely.5
In addition, the FDA continues to actively monitor and ensure the safety of drugs after approval. Among its post-marketing activities, the agency analyzes reports of adverse reactions submitted by companies and health care practitioners, and in some cases requires pharmaceutical manufacturers to conduct additional post-marketing testing (Phase IV trials) to evaluate long-term effects of approved medicines.
What can patients do to protect themselves from unsafe drugs?
Patients can be confident that the drug they are taking has been thoroughly studied and evaluated in a series of clinical trials before the FDA approved it for the public. Nevertheless, there are some important steps patients should take to make sure their medicines are safe for them:
- Understand the side effects
- Follow the directions on how to take the medicine
- Monitor how the medicine makes you feel and report this to your physician
- Only fill prescriptions from a reputable pharmacy that has a licensed pharmacist on staff; avoid internet pharmacies and be aware of counterfeit drugs.
Are unsafe drugs allowed in the market?
No. However, on rare occasions, negative side effects for a particular drug may become apparent after it’s been approved for the general population and large numbers of patients begin using it. In those cases, the FDA and pharmaceutical companies work together to educate the public about those risks and, on rare occasions, remove the medicine from the marketplace.
Are there ways to make drugs even safer?
Pharmaceutical manufacturers are dedicated to educating the public about drug safety. In addition, the companies are committed to:
- Improve the adverse event reporting system to make it easier for patients and physicians to report issues
- Provide the FDA with the additional resources it needs to collect, analyze, and evaluate drug safety data in an efficient manner
- Provide the FDA with necessary funds to improve the way it communicates medicines’ potential risks to patients
3FDA Webview. ‘Accelerated Enforcement’ Now Against Unapproved Drugs. Available at: http://www.fdaweb.com/default.php?ea=fv&aid=D5104815&cate=FN. Accessed 3/15/07.
4U.S. Food and Drug Administration. PART 2: Is the FDA maintaining the quality of its premarketing reviews? Available at: http://www.fda.gov/oc/tfrm/Part2.html. Accessed 3/15/07.
5U.S. Food and Drug Administration. Frequently Asked Questions about CDER. Available at: http://www.fda.gov/cder/about/faq/default.htm#1. Accessed 3/12/07.