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Drugs & Other Medical Products - FAQs:
Although some online pharmacies are legitimate businesses, patients must be cautious when purchasing drugs over the Internet. Patients should not buy drugs from web sites that:
- are not registered on a search engine;
- offer to prescribe a prescription drug without a physical exam;
- sell drugs not approved by the HHS Food and Drug Administration (FDA);
- do not offer the opportunity to ask questions of a registered pharmacist;
- require that you link to another web site to purchase the drug; and
- do not provide a U.S. phone number and address to contact for questions.
Before buying a prescription drug over the Internet, patients should check with the National Association of Boards of Pharmacy to see if the online pharmacy possesses a valid pharmacy license and has met state practice standards. Patients who believe that a web site is unlawfully selling a drug should report it to the National Association of Boards of Pharmacy or to the FDA.
For more information on buying medical products online, see the Agency's "Buying Medicines and Medical Products Online" Web page: http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.
Medicines can treat and cure many health problems. However, they must be taken properly to ensure that they are safe and effective. Many medicines have powerful ingredients that interact with the human body in different ways, and diet and lifestyle can sometimes have a significant impact on a drug's ability to work in the body. Certain foods, beverages, alcohol, caffeine, and even cigarettes can interact with medicines. This may make them less effective or may cause dangerous side effects or other problems.
When you take medicine, be sure to follow your doctor's instructions carefully to obtain the maximum benefit with the least risk. Changes in a medicine's effect due to an interaction with food, alcohol or caffeine can be significant; however, there are many individual factors that influence the potential for such variations, like dose, age, weight, sex, and overall health.
If you have any questions or concerns about possible drug interactions, consult your health care professional. Make sure your doctor and pharmacist know about every drug you are taking, including nonprescription drugs and any dietary supplements such as vitamins, minerals and herbals. If you have problems or experience side effects related to medication, call your health care provider right away.
It is also important to remember that many drugs interact with other drugs and may cause serious medical conditions. Not only can drugs interact with food and alcohol, they can also interact with each other. Some drugs are given together on purpose for an added effect, like codeine and acetaminophen for pain relief. But other drug-to-drug interactions may be unintended and harmful. Prescription drugs can interact with each other or with over-the-counter (OTC) drugs, such as acetaminophen, aspirin, and cold medicine. Likewise, OTC drugs can interact with each other. Sometimes the effect of one drug may be increased or decreased. For example, tricyclic antidepressants such as amitriptyline (ELAVIL), or nortriptyline (PAMELOR) can decrease the ability of clonidine (CATAPRES) to lower blood pressure.
In other cases, the effects of a drug can increase the risk of serious side effects. For example, some antifungal medications such as itraconazole (SPORANOX) and ketoconazole (NIZORAL) can interfere with the way some cholesterol-lowering medications are broken down by the body. This can increase the risk of a serious side effect.
Due to confidentiality rules, the Food and Drug Administration (FDA) is prohibited from releasing information on any drug under development, review or pending approval unless the information has been made public. You may contact the manufacturer directly to ask about products under development.
Another possible source of information is the Pharmaceutical Research and Manufacturers of America (PhRMA).
FDA does provide information about the following subjects related to drugs:
Emergency Preparedness
Bioterrorism, drug preparedness and natural disaster response
Drug Approvals and Databases
Drug-Related Databases from FDA; Information on Drug Approvals
Drug Safety and Availability
Medication Guides, Drug Shortages, Public Health Advisories and Other Safety Announcements
Development & Approval Process (Drugs)
Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements
Guidance, Compliance & Regulatory Information
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs
What's New on FDA Drug Approval Listing, Meetings and Conferences
Science & Research (Drugs)Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products
Resources for YouFor Consumers, Health Professionals, Industry
The HHS Food and Drug Administration (FDA) works with pharmaceutical companies to ensure that all drugs marketed in the United States meet specifications for identity, strength, quality, purity, and potency. Before approving a generic drug product, FDA requires many rigorous tests and procedures to ensure that the generic drug can be substituted for the brand name drug.
FDA bases evaluations of substitutability or "therapeutic equivalence" for generic drugs on scientific evaluations. By law, generic drug products must contain the identical amounts of the same active drug ingredient as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. FDA considers drug products to be substitutable if they meet the criteria of therapeutic equivalence, even though the generic drug may differ in certain other characteristics (e.g., shape, flavor, or preservatives).
For more information on generic drugs (FAQs), please visit: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm
From aspirin to cancer treatments, FDA's Center for Drug Evaluation and Research (CDER) ensures that the benefits of drug products outweigh any known risks. The Center has oversight responsibilities for prescription, over-the-counter and generic drugs. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens.
CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label, or--if necessary--remove a product from the market. Specifically, CDER regulates:
- Prescription Drugs: Prescription medicines include any drug product that requires a doctor's authorization to purchase.
- Generic Drugs: A generic drug is a drug product that is equivalent to brand name products in terms of quality and performance.
- Over-the-Counter Drugs: OTC drug products are available to consumers without a doctor's prescription.
A clinical trial is a research study conducted to evaluate a medical procedure or medical product, such as a drug. Each study is designed to answer scientific questions and find new and better ways to help people. With any new drug there are benefits as well as possible risks. There may also be some risks that are not yet known.
Clinical trials help us find out if promising new treatments are safe and effective for patients. During a clinical trial, more and more information is gained about a new drug, its risks, and how well it may or may not work. You may be interested in or asked to enter a trial. Learn as much as you can about the clinical trial before deciding. Only patients that volunteer take part in a clinical trial.
Learn More:
- ClinicalTrials.gov
- Educational Materials About Clinical Trials (National Cancer Institute/NIH)
- Clinical Trials (National Institute of Mental Health/NIH)
- Clinical Research & Clinical Trials (National Institute of Child Health and Human Development/NIH)
- Alzheimer's Clinical Trials (National Institute on Aging/NIH)
- Clinical Trials/Studies Seeking Patients (National Heart, Lung, and Blood Institute/NIH)
- Clinical Trials and Guidelines (National Digestive Diseases Information Clearinghouse/NIH)
- Women & HIV/AIDS Research and Clinical Trials (Womenshealth.gov)
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
For more information, see: http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Consumers/default.htm.
