Prescription Drug Legal Glossary

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Abuse-Liable: Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit and licit drugs.

Accolate: Accolate is a non-steroidal tablet intended for the prevention and continuous treatment of asthma in children and adults. FDA approved in September 1996, Accolate is manufactured by Zeneca Pharmaceuticals. In approximately 10 months on the market, Accolate was prescribed to around 250,000 U.S. patients. On July 22, 1997, the manufacturer of Accolate sent a letter to healthcare professionals that the company was making changes to the enclosed package insert for the asthma drug. Included in the revisions were warnings that the drug had been associated to rare occurrences of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes presenting as Churg Strauss Syndrome. Accolate manufacturer AstraZeneca warned that Accolate side effects were potentially deadly. Accolate side effects included severe liver damage. First surfacing in 2000, Accolate side effects had been more closely monitored by the FDA. The FDA told AstraZeneca to alert physicians of the dangerous side effects in September 2000. The company did not send out official FDA warnings regarding Accolate side effects, but instead just sent out physician notices in that month’s Physician’s Desk Reference. Women are at a much higher risk for suffering Accolate side effects like liver damage and it is advised for women to undergo regular blood tests to screen for the presence of Accolate side effects. Accolate patients experiencing fever, stomach pain, rash, jaundice, or nausea may be suffering serious side effects and should consult their physician. As a part of that warning AstraZeneca advised patients to seek medical attention if they were experiencing any of the following problems:

• Feeling itchy
• Feeling like you have the flu
• Feeling sick
• Feeling tired or lacking energy
• Loss of appetite
• Pain on right side of stomach, just below ribs
• Yellowing coloring of skin and eyes 

Accutane: Once the most often-prescribed acne medication on the U.S. market, Accutane is now considered a defective drug, having been associated with depression, suicide, psychosis, and birth defects, namely mental retardation and physical deformities. Accutane is still available by prescription, although women who are at risk for becoming pregnant while on the drug must sign a waiver that informs them of the risk before they are given a prescription. 

Acetaminophen: A medication effective for relieving mild pain and fever. It is also used as a non-steroidal anti-inflammatory. 

ADAMHA: Alcohol, Drug Abuse, and Mental Health Administration; reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration. 

Addiction: A physiological and psychological compulsion for a habit-forming substance. In extreme cases, an addiction may become an overwhelming obsession. 

Adjuvant Therapy: A therapy provided to enhance the effect of a primary therapy; otherwise known as an auxiliary therapy.

Adverse Effect: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (i.e. headache following spinal tap or intestinal bleeding associated with aspirin therapy).

Affidavit: A written statement under oath.

Agonist Opioid: Generic term for medications that relieve pain. Some analgesics like aspirin have a low pain-relieving threshold, whereas others like Oxycodone have a much higher ceiling.

Agreement: Mutual assent between two or more parties; normally leads to a contract; may be verbal or written.

Aleve: A recent study links naproxen, sold under the brand name Aleve, to an increased risk of heart attacks and strokes. The Aleve announcement by federal health officials on Monday, December 20, 2004, was termed cautionary; the drug remains on the market. Aleve, the popular over-the-counter pain reliever made by Bayer, was part of a three-year study by the National Institutes of Health. The agency ended the study because of the heart risks it discovered, and also stopped giving Aleve to study participants. Aleve is part of a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs, and are used to relieve arthritis and related chronic joint conditions. Aleve has been on the market since 1994. Naprosyn, the prescription version of Aleve, has been on the market since 1976. Other NSAIDs that have been on the market a long time include aspirin, acetaminophen and ibuprofen. In January 2004, the Food & Drug Administration sent a letter to the State Boards of Pharmacy regarding important safety issues for all products that contain NSAIDs. An FDA warning advises patients not to take naproxen (the generic form of Aleve) for more than 10 days unless directed by a doctor, and only in the amounts specified on its label: No more than two pills a day. The FDA warning pertains to all drugs that contain naproxen as the active ingredient. Other brand names of naproxen include Anaprox and Naprelan. It is unclear how Aleve caused the increased risk of heart attacks and strokes, but NSAIDs are suspected of increasing the likelihood of developing blood clots, which can block blood vessels to the heart. Researchers are still trying to understand the link between NSAIDs like Aleve and increased heart risk.

Amiodarone: This drug is linked to severe side effects such as blindness and lung damage. Amiodarone is an anti-arrhythmic drug used to correct irregular heartbeats to normal rhythm. Amiodarone is widely prescribed to treat heart rhythm disorders such as atrial fibrillation and atrial flutter. It is important to understand that Amiodarone is not approved for use and may not be suitable for use other than for treatment of life-threatening recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia, when all other available heart arrhythmia drugs have proved ineffective. Doctors are prescribing this drug for off-label use without warning their patients about the drug’s life-threatening side effects or that the FDA had not approved their treatment as safe and effective.

Anemia: A condition in which a person has a lower than normal number of red blood cells. Exposure to toxic chemicals can contribute to the development of anemia. 

Anesthesia injury: An injury sustained from incorrectly administered anesthetics.

Answer: Pleading filed by the defendant that responds to a complaint, petition, or motion.

Antidepressants: A type of drug used to control or reduce depression. Some antidepressants have been found to have serious side effects.

Appeal: A request to the higher court for review of the lower court’s decision and to request a reversal of the judgment.

Arava: An oral medicine prescribed to slow the progress of Rheumatoid Arthritis. Arava may cause liver dysfunction and birth defects.

Arbitration: The procedure by which a dispute may be resolved by a person who is not a judge. Arbitration is often used to limit legal costs to both parties.

Arbitrator: A person who conducts an arbitration.

Arbritration: The procedure by which a dispute may be resolved by a person who is not a judge. Arbitration is often used to limit legal costs to both parties.

Assent: Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

Assumption of Risk: A doctrine that states if the plaintiff has knowingly accepted the danger of doing something, recovery from the defendant in an action brought for negligence will be barred.

Assurance (as it relates to FDA research): A formal written, binding commitment which promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

Autonomy: Personal capacity to consider alternative choices and act without undue influence or interference of others.

Autopsy: Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.