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.
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.
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.
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.
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.
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.
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.
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.
|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|
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.
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.
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 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.
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 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 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.
Please seek the advice of a medical professional before making health care decisions.
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