Drug Side Effects and Medical Device Complications

Prescription drugs and medical devices can come with unwanted side effects and complications. These serious adverse events can be life-threatening and potentially fatal. Enter the adverse events you are experiencing into the box below to discover possible links to prescription drugs and medical devices.

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    Even though the U.S. Food and Drug Administration may approve a drug or medical device for use, it may still cause side effects or complications for some patients. Manufacturers, regulators and health care professionals have to weigh the benefits of a drug or device against its risks. Sometimes this means comparing risks to benefits for the general population. Other times it may mean comparing risks to benefits for an individual patient.

    Device Hospital

    For the most part, serious side effects and complications are rare. But people taking medicines, undergoing surgery or receiving a medical implant should be aware of potential side effects.

    What are Severe Drug Side Effects?

    Severe side effects from drugs can range from infections to death.

    If a drug has numerous reports of a particular problem, the U.S. Food and Drug Administration can add warnings to the drug’s label, including its stringent black box warning. In rare cases, the drug is recalled or removed from the market.

    The FDA refers to side effects or other problematic consequences of drugs and medical devices as “adverse events.” Under federal regulations, adverse events include any unexpected or unfavorable medical occurrence whether it is related to the drug or not.

    Drug Adverse Events

    FDA serious adverse events include:

    • Death
    • A life-threatening condition
    • Hospitalization
    • Disability
    • Congenital anomaly – any affect from prior to conception through pregnancy that may have an adverse outcome on the fetus or child
    • Intervention required to prevent permanent impairment or damage

    Tracking Adverse Events

    From 2011 to mid-2017, the FDA received more than 5.4 million reports of prescription drug adverse events, including more than 1 million deaths. The agency keeps these reports in its FDA Adverse Events Reporting System (FAERS) database. Consumers can search for side effects of specific drugs reported to the FDA at the agency’s Public Dashboard.

    Regulators can use this data to look for “signals,” indications there may be a potential safety issue with a particular drug. These may occur when there is a spike in the number of reports of a particular side effect.

    These reports, along with scientific studies, can help determine if regulators should issue warnings of serious side effects to the public and health care professionals or require drug makers add warnings to their drug labels.

    Serious Side Effects of Commonly Prescribed Drugs:

    Drug Cancer Death Heart Issues Infection Kidney Damage Liver Damage Pancreatitis Stroke Suicide
    Abilify
    Fluoroquinolones
    Onglyza
    PPIs
    Risperdal (Invega)
    SGLT2 Inhibitors
    SSRIs
    Talc
    Taxotere
    Testosterone
    Xarelto

    Severe Medical Device Complications

    Complications of medical devices include risks from surgery, infection and device failure. All surgeries include some level of risk. These may be minor bruising or more serious, such as a reaction to anesthesia.

    The risk of infection is common to all surgeries, and can be a serious complication of medical devices. Treating an infection may be as simple as taking antibiotics or as complex as a second surgery to remove and replace a device.

    Severe Complications of Medical Devices:

    • Death
    • Device breakage or failure
    • Device migration
    • Infection
    • Organ damage
    • Perforation
    • Revision surgery

    Medical Device Complication Discovery

    The FDA defines medical devices as just about any device used in the diagnosis, treatment, prevention or cure of a medical condition. These can include surgical instruments or devices left temporarily or permanently in the human body such as hip and knee implants, surgical mesh, and pacemakers.

    Medical Device Testing

    Did You Know

    Unlike prescription drugs, many medical devices are sold with little or no testing before they receive FDA approval. Most serious complications with these devices are detected only after they’ve been in use for some time by the general population.

    Many of these devices gain approval through the FDA’s 510(k) clearance process. This allows companies to market a new device if they can show it is “substantially similar” to other products already on the market.

    Some high-risk devices do require advanced safety studies, but federal regulations allow for smaller and less rigorous trials than what is required for prescription drugs.

    Some medical devices have been found to have serious complications specific to the device. These may be due to a design flaw or a manufacturing defect.

    Severe Complications of Common Medical Devices:

    Device Death Device Failure Migration Infection Organ Damage Perforation Surgery
    Bair Hugger Blankets
    Essure
    Heater-Cooler Devices
    Hernia Mesh
    Hip Implants
    IV Flush Syringes
    IVC Filters
    Knee Implants
    Duodenoscopes
    Transvaginal Mesh

    Minor Side Effects and Complications

    Prescription drugs and medical devices may also have minor side effects and complications.

    Possibly the most common side effects of any prescription drug are gastrointestinal issues, including nausea, constipation and diarrhea, because most drugs go through the digestive system to be absorbed. Other common effects include drowsiness, pain and skin reactions. Minor complications from medical devices could include varying levels of pain.

    Prescription Drugs

    Common Minor Side Effects of Prescription Drugs:

    • Diarrhea
    • Dizziness
    • Drowsiness
    • Fatigue
    • Heart issues (palpitations, irregular heartbeats)
    • Hives
    • Nausea and vomiting
    • Rash
    • Stomach upset

    Common Side Effects by Drug Type:

    Drug Type Common Side Effects
    Antibiotics Nausea, diarrhea, rash, yeast infection, fever
    Antidepressants Weight gain, insomnia, nervousness
    Antihistamines, allergy medications Drowsiness, insomnia, weakness
    Asthma medications Nervousness, sweating, nausea, vomiting
    Decongestants Nose bleed, nasal irritation
    Diabetes medications Nausea, heartburn, fatigue, dizziness
    Heart and blood pressure medications Dizziness, drowsiness, chest pain, loss of appetite, leg pain
    Heartburn medications Constipation, bloating
    Pain relievers Stomach upset, tinnitus, nausea

    Common Minor Side Effects of Medical Devices

    Minor side effects are generally defined as those that may be uncomfortable for the patient, but does not threaten the person’s health or is so uncomfortable the device has to be removed or repaired.

    Most minor side effects or complications involving medical devices happen through surgery. This may involve a tool used during an operation or a device implanted into the body.

    Device Complications

    Minor side effects and complications from medical devices include:

    • Bruising around the surgical site
    • Mild allergic or other reaction
    • Minor infection
    • Numbness
    • Pain
    • Redness
    • Swelling

    Most minor complications can be treated with medication. If these conditions persist or worsen, they may be a sign of a more serious problem and you should talk to a doctor immediately.

    High-Risk Conditions

    People who have serious health conditions such as heart disease, cancer or diabetes frequently have other medical conditions as well. The medications they take for these other conditions may present serious side effects or complications that make their conditions worse. Medical devices they rely on may also affect their risk of complications or affect their treatment.

    Diabetes

    Diabetes is a group of conditions in which the body is not able to produce or respond to a critical hormone called insulin. People who develop diabetes have too much sugar in their blood. Your risk for developing diabetes can include family history, excess weight, lack of exercise and improper diet.

    People diagnosed with diabetes may take medicines for other conditions such as allergies or high blood pressure. But some of those medications or conditions may worsen their diabetes or affect their medical devices for treating the disease.

    Diabetes Complications

    If you have diabetes, you should be aware of the risks from:

    • Antipsychotic drugs
    • Beta-blockers (high blood pressure, glaucoma drugs)
    • Glucocorticoids (steroids)
    • Niacin (cholesterol medication)
    • Thiazide diuretics (blood pressure drugs)

    Heart Disease and Stroke

    Heart disease includes both heart attacks and heart failure. Both are usually the result of coronary artery disease, a condition where fat and other materials can build up in arteries, making them harder and narrower.

    The most serious side effects include:

    • NSAIDS (pain relievers)
    • Decongestants, allergy and cold medications
    • Weight-loss drugs

    The American Heart Association lists more than 100 different drugs that pose a risk to people with heart disease. Many of these drugs can also interfere with treatment after a stroke.

    People with heart disease take an average of seven drugs every day just to treat that one condition. This can also increase the risk of a dangerous drug interaction with other medicines they may take. Heart and stroke patients should make sure every doctor they visit is aware of all the medications they are taking and never take drugs without first checking with their doctor.

    Cancer

    Cancer is a condition in which abnormal cells in the body start dividing out-of-control and invade nearby organs or other tissue. It can spread throughout the body through the bloodstream or through a person’s lymph nodes — small glands throughout the body.

    Medications cancer patients take for other conditions — from heartburn to depression — can change the way the body absorbs to cancer drugs. This effect may weaken cancer drugs or make them more toxic.

    Medications that affect cancer drugs’ effectiveness include:

    • Anticonvulsants – drugs that stop seizures or treat epilepsy
    • Antidepressants – including SSRIs such as Paxil (paroxetine) and Prozac (fluoxetine)
    • Antifungal drugs
    • Calcium channel blockers – used to treat hypertension, high blood pressure
    • HIV therapy drugs
    • Proton pump inhibitors – heartburn drugs including Prilosec (omeprazole), Nexium (esomeprazole) and Prevacid
    • Certain antibiotics – fluoroquinolones such as Cipro (ciprofloxacin)
    • Statins – cholesterol medicines such as Crestor (rosuvastatin) and Lipitor (atorvastatin)
    • Steroids – including testosterone replacement therapy such as AndroGel

    Author

    Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


    Hide Sources

    1. Light, D.W. (2014, June 27). New Prescription Drugs: A Major Health Risk with Few Offsetting Advantages. Retrieved from: https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages
    2. Barry, P. (2011, September 1). Prescription Drug Side Effects. AARP. Retrieved from: http://www.aarp.org/health/drugs-supplements/info-09-2011/prescription-drug-side-effects.html
    3. Prescription for Trouble. (January 2006). ConsumerReports.org. Retrieved from: http://www.consumerreports.org/cro/health/drugs/index.htm
    4. Dangerous Prescription. (2003, November 13). PBS Frontline. Retrieved fromhttp://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/synopsis.html
    5. FDA. (2016, February 2). What is a Serious Adverse Event? Retrieved from: https://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm
    6. World Health Organization. (n.d.). Definitions. Retrieved from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/trainingcourses/definitions.pdf
    7. FDA. (2017, January 26). Learning About Side Effects. Retrieved from: https://www.fda.gov/drugs/resourcesforyou/consumers/ucm196029.htm
    8. American Academy of Allergy Asthma & Immunology. (n.d.). Medications and Drug Allergic Reactions. Retrieved from: http://www.aaaai.org/conditions-and-treatments/library/at-a-glance/medications-and-drug-allergic-reactions
    9. Kentucky Cabinet for Health and Family Services. (n.d.). Common Medication Classification and Adverse/Side Effects. Retrieved from: http://training.chfs.ky.gov/school_med_admin1/train/html/Common_Medication.pdf
    10. Kantor, E.D., et al. (2015, November 3). Trends in Prescription Use Among Adults in the United States from 1999-2012. Retrieved from: http://jamanetwork.com/journals/jama/fullarticle/2467552
    11. FDA. (n.d.). FDA Drug Approval Process. Retrieved from: https://www.fda.gov/downloads/drugs/resourcesforyou/consumers/ucm284393.pdf
    12. FDA. (2017, April 1). CRR – Code of Federal Regulations Title 21. Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32
    13. Consumer Reports. (2012, May). Dangerous Medical Implants and Devices. Retrieved from: https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm
    14. Groeger, L. (2012, April 30). 4 Medical Implants that Escaped FDA Scrutiny. Retrieved from: https://www.scientificamerican.com/article/four-medical-implants-escaped-fda-scrutiny/
    15. FDA. (2015, June 24). Implants and Prosthetics. Retrieved from: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/default.htm
    16. FDA. (2013, March 14). FDA Drug Safety Communication: FDA Investigating Reports of possible Increased Risk of Pancreatitis and Pre-Cancerous Findings of the Pancreas from Incretin Mimetic Drugs for Type 2 Diabetes. Retrieved from: https://www.fda.gov/Drugs/DrugSafety/ucm343187.htm
    17. FDA. (2017, May 16). FDA Drug Safety Communication: FDA Confirms Increased Risk of Leg and Foot Amputations with the Diabetes Medicine Canagliflozin (Invokana, Invokamet, Invokamet XR). Retrieved from: https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm
    18. FDA. (2015, December 4). SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections. Retrieved from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475553.htm
    19. Reefhuis, J., et al. (2015, July 8). Specific SSRIs and Birth Defects: Bayesian Analysis to Interpret New Data in the Context of Previous Reports. Retrieved from: http://www.bmj.com/content/351/bmj.h3190
    20. FDA. (2008, July 8). Information for Healthcare Professionals: Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR), Gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin)]. Retrieved from: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
    21. FDA. (2016, March 14). Preventable Adverse Drug Reactions: A Focus on Drug Interactions. Retrieved from: https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm110632.htm#ADRs