Terms and Words in Dangerous Drug and Device Cases

The FDA defines an adverse event as "any undesirable experience associated with the use of a medical product in a patient." Health care providers should report an if it results in death, disability, hospitalization, is life-threatening, causes a congenital anomaly, or requires treatment to prevent permanent damage.

Medication for pain relief

An MRI study of a blood vessel, usually an artery

A cancer-causing chemical or other substance which promotes the growth of a cancer. Examples of know carcinogens are arsenic, benzene, asbestos, radon, and uranium.

A class of drugs) that selectively block one form, COX-2, but not the other form, COX-1, of the enzyme cyclooxygenase and that are intended to relieve the pain and inflammation of arthritis while minimizing gastrointestinal side effects

The formation of a blood clot in a large vein deep in the body. Most such clots form in the large veins of the thigh and legs. If the clot, or thrombus, breaks loose, it can travel through the circulatory system and lodge in the lungs or in a coronary artery.

An electronic device used to defibrillate the heart, by applying an electric shock to it. Fibrillation is very rapid irregular contractions of the muscle fibers of the heart resulting in a lack of synchronism between heartbeat and pulse. If it is not stopped, fibrillation can be fatal.

A stent coated with a drug. Once the stent is implanted, the drug is slowly released into the body.

A procedure authorized in 1997 that permits pharmaceutical manufacturers to speed up their applications for new drugs to the FDA.

Dyes used in MRI studies. GBCA’s are not FDA approved for use in angiograms, but are frequently used off-label.

Non-steroidal anti-inflammatory drug. A large class of pain-reducing drugs, including aspirin and ibuprofen, and naproxen.

The practice of prescribing and using of a drug for a purpose outside the scope for which the drug was approved. The FDA leaves the use of a drug to the physician’s judgment, and does not regard off-label use as illegal. However, it is unlawful for a pharmaceutical company to market, advertise or otherwise promote the off-label use of drugs

A term for medications that can be purchased without a prescription. Vitamins, supplements, and aspirin are all examples of over-the-counter medications.

An electrical device for stimulating or steadying the heartbeat or reestablishing the rhythm of an arrested heart.

A secondary, unintended, and usually adverse effect of a drug, called also side reaction. An example is the drowsiness caused by many antihistamines.

A short tube inserted into a vein, artery, or other natural conduit of the body to improve flow of fluids such as blood. A stent may also be used to prevent or reverse a constriction of flow induced by disease.

The formation or presence of a blood clot inside a blood vessel.