In the U.S., the government's Food and Drug Administration (FDA) must approve any drug - whether it's prescription or over-the-counter - before it can be sold. The FDA evaluates the safety of a drug by looking at side effects, how it's manufactured, results of animal testing and clinical trials, and more. The FDA also monitors a drug's safety after approval.
To make sure you use drugs safely
- Make sure that you understand and follow the instructions on taking the drug
- Don't share medicines
- Let your health care provider know about all other drugs, supplements and herbs you are taking
- Check Your Medicines(Agency for Healthcare Research and Quality) - http://www.ahrq.gov/consumer/checkmeds.htm
- Consumer Education: What You Need to Know to Use Medicine Safely(Center for Drug Evaluation and Research) - http://www.fda.gov/cder/consumerinfo/DPAdefault.htm
- Find the Latest Drug Product and Safety Information(Food and Drug Administration) - http://www.fda.gov/consumer/updates/druginfo041108.html
- From Test Tube to Patient: Protecting America's Health through Human Drugs(Food and Drug Administration) - http://www.fda.gov/fdac/special/testTubeToPatient/default.htm
- Medicine Safety: Who's at Risk and What You Can Do(Centers for Disease Control and Prevention) - http://www.cdc.gov/Features/MedicineSafety/
- Recalls, Market Withdrawals and Safety Alerts(Food and Drug Administration) - http://www.fda.gov/opacom/7alerts.html
- Speak Up: Help Avoid Mistakes with Your Medicines(Joint Commission on Accreditation of Healthcare Organizations) - Links to PDF - http://www.jointcommission.org/NR/rdonlyres/BF7973E4-BCEC-42E1-BB59-7D7D207D4870/0/speakup_brochure_meds.pdf
-
Use Medicine Safely
(Food and Drug Administration) - http://www.fda.gov/opacom/lowlit/medsafe.html
Also available in Spanish http://www.fda.gov/opacom/lowlit/medicina.html
- Plavix, Heartburn Drugs May Be Risky Combination(05/06/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_83909.html
- Anemia Drugs May Raise Death Risk in Cancer Patients(05/01/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_83636.html
- FDA Mandates New Warnings for Botox(04/30/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_83631.html
- FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs(04/10/2009, Food and Drug Administration) - http://www.fda.gov/bbs/topics/NEWS/2009/NEW01995.html
- FDA Statement on the Voluntary Withdrawal of Raptiva from the U.S. Market(04/08/2009, Food and Drug Administration) - http://www.fda.gov/bbs/topics/NEWS/2009/NEW01992.html
- FDA Takes Action Against KV Pharmaceutical Company(03/02/2009, Food and Drug Administration) - http://www.fda.gov/bbs/topics/NEWS/2009/NEW01965.html
- More News on Drug Safety http://www.nlm.nih.gov/medlineplus/alphanews_d.html#drugsafety
-
Drug Interactions: What You Should Know(Center for Drug Evaluation and Research) - http://www.fda.gov/cder/consumerinfo/druginteractions.htm
Also available in Spanish http://www.fda.gov/cder/consumerinfo/druginteractions-spanish.htm
- General Advice on Safe Medication Use(Institute for Safe Medication Practices) - http://www.ismp.org/consumers/brochure.asp
-
Generic Drugs: Questions and Answers(Food and Drug Administration) - http://www.fda.gov/cder/consumerinfo/generics_q&a.htm
Also available in Spanish http://www.fda.gov/cder/consumerinfo/generics_q&aSpanish.htm
- Grapefruit Juice: Can It Cause Drug Interactions?(Mayo Foundation for Medical Education and Research) - http://www.mayoclinic.com/print/food-and-nutrition/AN00413/METHOD=print
- Penny Wise/Pound Foolish? Breaking Tablets to Save Money May Be Dangerous(Institute for Safe Medication Practices) - http://www.ismp.org/consumers/Penny.asp
- Request a Brown-Bag Check-Up(Institute for Safe Medication Practices) - http://www.ismp.org/Newsletters/consumer/alerts/BrownBag.asp
- Throw Away Your Old Medicines Safely(Institute for Safe Medication Practices) - http://www.ismp.org/consumers/throwAwayMedsSafely.asp
- To Chew, or Not to Chew? Patient Dies After Chewing Medication(Institute for Safe Medication Practices) - http://www.ismp.org/consumers/chewable.asp
- Treat Medication Samples with Respect(Institute for Safe Medication Practices) - http://www.ismp.org/Newsletters/consumer/alerts/Samples.asp
-
Buying Drugs Online (Internet)(Food and Drug Administration, Office of Women's Health) - http://www.fda.gov/womens/getthefacts/onlinedrugs.html
- Buying Medicines and Medical Products Online(Food and Drug Administration) - http://www.fda.gov/oc/buyonline/
- Buying Prescription Drugs Online: The Do's and Don'ts(Mayo Foundation for Medical Education and Research) - http://www.mayoclinic.com/print/buying-prescription-drugs-online/GA00042/METHOD=print
- Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names(Food and Drug Administration) - http://www.fda.gov/oc/opacom/reports/confusingnames.html
- Counterfeit Drugs(Food and Drug Administration) - http://www.fda.gov/counterfeit/
- Drug Name Confusion: Preventing Medication Errors(Food and Drug Administration) - http://www.fda.gov/fdac/features/2005/405_confusion.html
- Drugs Marketed in the United States That Do Not Have Required FDA Approval(Food and Drug Administration) - http://www.fda.gov/cder/drug/unapproved_drugs/default.htm
- FDA 101: Biological Products(Food and Drug Administration) - http://www.fda.gov/consumer/updates/biologics062608.html
- FDA 101: Product Recalls(Food and Drug Administration) - http://www.fda.gov/consumer/updates/recalls123107.html
- FDA and Product Recalls(Food and Drug Administration) - http://www.fda.gov/fdac/features/2006/306_recalls.html
- Impact of Severe Weather Conditions on Biological Products(Center for Biologics Evaluation and Research) - http://www.fda.gov/cber/weatherimpact.htm
- Is It Really FDA Approved?(Food and Drug Administration) - http://www.fda.gov/consumer/updates/approvals093008.html
- Managing Drug Safety Issues(Food and Drug Administration) - http://www.fda.gov/consumer/updates/drugsafetyqa053107.html
- MedWatch, the FDA Safety Information and Adverse Effect Reporting Program(Center for Drug Evaluation and Research) - http://www.fda.gov/medwatch/
- Off-Label Drugs and Medical Devices(Mayo Foundation for Medical Education and Research) - http://www.mayoclinic.com/print/off-label/DI00088/METHOD=print
- Postmarket Drug Safety Information(Food and Drug Administration) - http://www.fda.gov/cder/drugSafety.htm
- Sentinel System to Monitor Medical Product Safety(Food and Drug Administration) - http://www.fda.gov/consumer/updates/sentinel052208.html
- Strengthening Drug Safety(Food and Drug Administration) - http://www.fda.gov/consumer/features/drugsafety0607.html
-
Substandard and Counterfeit Medicines(World Health Organization) - http://www.who.int/mediacentre/factsheets/fs275/en/
Also available in Spanish http://www.who.int/mediacentre/factsheets/fs275/es/
- Your Guide to Reporting Problems to FDA(Food and Drug Administration) - http://www.fda.gov/consumer/updates/reporting_guide061008.html
-
Effect of Drug Concentration Expression on Epinephrine Dosing Errors(American College of Physicians) - Links to PDF - http://www.annals.org/cgi/reprint/148/1/I-30.pdf
- FDA and Nanotechnology Products: FAQs(Food and Drug Administration) - http://www.fda.gov/nanotechnology/faqs.html
- FDA Readies for More 'Nanoscale' Challenges(Food and Drug Administration) - http://www.fda.gov/consumer/updates/nanotech072507.html
References and abstracts from MEDLINE/PubMed (National Library of Medicine)
- Article: Preface. - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19373986&tool=MedlinePlus
- Article: Application of toxicogenomic tools in the drug research and development... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19373985&tool=MedlinePlus
- Article: Implanon sub-dermal implants: a 10-month review of acceptability in Jos,... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19320403&tool=MedlinePlus
- Drug Safety -- see more articles - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&term=safety[majr]+OR+safety+management[majr]+AND+(pharmaceutical+preparations[majr]+OR+drug+labeling[mh])+OR+(pharmaceutical+preparations/ae[majr]+OR+pharmaceutical+preparations/ct[majr])+AND+english[la]+AND+humans[mh]+NOT+(letter[pt]+OR+editorial[pt]+OR+case+reports[pt])&doptcmdl=summary&cmd_current=Limits&pmfilter_EDatLimit=last+1+Year&tool=MedlinePlus
- Guide to Drug Safety Terms at FDA(Food and Drug Administration) - http://www.fda.gov/consumer/updates/drugterms041108.html
- Center for Biologics Evaluation and Research - http://www.fda.gov/cber/
- Center for Drug Evaluation and Research - http://www.fda.gov/cder/
- Institute for Safe Medication Practices - http://www.ismp.org/
- SafeMedication.com(American Society of Health-System Pharmacists) - http://www.safemedication.com/
- FDA Consumer(Food and Drug Administration) - http://www.fda.gov/fdac/fdacindex.html
- FDA Law Enforcement: Critical to Product Safety(Food and Drug Administration) - http://www.fda.gov/fdac/features/2006/106_ora.html
- FDA Takes Action against Unapproved Drugs(Food and Drug Administration) - http://www.fda.gov/fdac/features/2007/107_drug.html
- How to Report Problems with Products Regulated by FDA(Food and Drug Administration) - http://www.fda.gov/opacom/backgrounders/problem.html
- Special Risks of Pharmacy Compounding(Food and Drug Administration) - http://www.fda.gov/consumer/updates/compounding053107.html
- Vaccine Adverse Event Report System(Center for Biologics Evaluation and Research) - http://www.fda.gov/cber/vaers/vaers.htm
-
20 Tips to Help Prevent Medical Errors in Children(Agency for Healthcare Research and Quality) - http://www.ahrq.gov/consumer/20tipkid.htm
Also available in Spanish http://www.ahrq.gov/consumer/20tkidsp.pdf
-
Medications: Using Them Safely(Nemours Foundation) - http://kidshealth.org/parent/system/medicine/medication_safety.html
Also available in Spanish http://kidshealth.org/parent/en_espanol/general/medication_safety_esp.html
- Medication Use and Older Adults(Food and Drug Administration) - http://www.fda.gov/fdac/features/2006/406_olderadults.html
-
Medicines: Use Them Safely
(National Institute on Aging) - http://www.niapublications.org/agepages/medicine.asp
Also available in Spanish http://www.niapublications.org/agepages/medicine-sp.asp -
Multiple Medicines(Consumers Union of U.S.) - Links to PDF - http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/money-saving-guides/english/MultipleMedicines-FINAL.pdf
- Diagnostic Imaging - http://www.nlm.nih.gov/medlineplus/diagnosticimaging.html
- Health Fraud - http://www.nlm.nih.gov/medlineplus/healthfraud.html
- Herbal Medicine - http://www.nlm.nih.gov/medlineplus/herbalmedicine.html
- Latex Allergy - http://www.nlm.nih.gov/medlineplus/latexallergy.html
- Medical Device Safety - http://www.nlm.nih.gov/medlineplus/medicaldevicesafety.html
- Medicines - http://www.nlm.nih.gov/medlineplus/medicines.html
- Vitamins - http://www.nlm.nih.gov/medlineplus/vitamins.html
- Drug Therapy - http://www.nlm.nih.gov/medlineplus/drugtherapy.html
- Safety Issues - http://www.nlm.nih.gov/medlineplus/safetyissues.html