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PRESCRIPTION DRUG LEGALGLOSSARY |
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Glossary of
Prescription Drug Terms
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Negligence: Failure to act with the prudence that a reasonable person would exercise under the same circumstances
Negligent Distribution/Marketing: Negligent distribution or marketing occurs when a company breaches a general duty to the public to exercise reasonable care when distributing its products.
Neurontin/Gabapentin: Medicine given for the treatment of partial seizures (when symptoms are limited) in patients with epilepsy and for the relief of nerve pain after shingles. Neurontin, available by prescription only, comes in capsule form to be taken three times a day. Approved by the U.S. Food and Drug Administration (FDA) in 1993, Neurontin is made by Pfizer, Inc. Side effects of Neurontin use included, but may not be limited to, drowsiness, headache, dizziness, unwanted eye movements, anxiety and nausea. The practice of promoting off-label uses of drugs is standard for medical doctors who are then able to use the latest medical findings to benefit patients without first waiting for regulatory approval for a new use of a drug. Drug companies, on the other hand, are not allowed to promote these off-label uses until FDA approval for it has been granted. The practice is becoming more heavily scrutinized as government agencies have been investigating big drug companies because of these unauthorized drug promotions. In 2000, Pfizer acquired Warner-Lambert and paid doctors consultant fees to attend conferences in Hawaii and Florida, as well as the 1996 Atlanta Olympics. According to the Justice Department, who was involved in investigating Pfizer's Warner-Lambert unit, the company discussed unapproved uses of its epilepsy drug Neurontin at these events. As a result, the company defrauded the government's Medicare and Medicaid programs by urging doctors to prescribe Neurontin for off-label purposes. Pfizer had previously said it had set aside $427 million to settle a whistle-blower lawsuit and federal and state investigations related to the Neurontin off-label sales. In July 2003, NBC’s television show, Dateline, ran a story accusing pharmaceutical company Warner-Lambert, which was acquired by Pfizer in 2000, of deliberately falsifying medical information about Neurontin so doctors would prescribe the drug for "off-label" uses. Although it is legal for physicians to prescribe medications for "off-label" uses, it is not legal for a drug company to promote unapproved uses or distort information about a medication's "off-label" benefits. In its year-long investigation, Dateline interviewed a former Warner-Lambert scientist who alleges company officials encouraged him to persuade physicians to prescribe Neurontin for a number of disorders, including attention deficit disorder and bipolar disease, even though there was minimal preliminary data indicating that Neurontin could help patients with those diseases. On May 13, 2004, Pfizer pled guilty to U.S. criminal charges of misbranding Neurontin and will pay more than $430 million to settle the charges. The $240 million criminal fine Pfizer is paying for health care fraud is a record amount according to the Justice Department, in addition to the $190 million in civil settlements with state and federal health care programs. The following is a list of illegally unapproved uses of Neurontin/Gabapentin:
- Bipolar Disorder (Suicide Effects)
- Pain Syndromes, Peripheral Neuropathy, and Diabetic Neuropathy
- Treatment of Epilepsy alone
- Reflex Sympathetic Dystrophy (RSD)
- Attention Deficit Disorder (ADD)
- Restless Leg Syndrome (RLS)
- Trigeminal Neuralgia
- Post-Hepatic Neuralgia (PHN)
- Essential Tremor Period Limb Movement
- Migraine
- Drug and Alcohol Withdrawal Seizures
Nevirapine: A drug prescribed for use in combination with other anti-HIV drugs. Nevirapine can cause a severe rash in some patients. Reports have also associated nevirapine with hepatotoxicity, a condition which can result in liver damage and death.
New Drug Application: Request for FDA approval to market a new drug.
Neurontin: The makers of Neurontin, an epilepsy-treatment drug, are currently facing an anti-trust lawsuit for extending their monopoly over the main ingredients in Neurontin well past the expiration of their patents. By preventing others from having access to the ingredients, the defendants, Pfizer, Inc. and the Warner-Lambert Company, cost users millions that they could have saved had there been a generic alternative available. The defendants, accused of violating the Sherman Anti-Trust Act, are also believed to have falsely claimed copyright infringement to prevent competitors from profiting.
Norplant: A contraceptive device that is implanted in the patient, Norplant provides birth control by releasing active agents over time. Norplant® has been associated with side effects such as irregular menstrual bleeding, headache, nervousness, depression, nausea, dizziness, skin rash, acne, change of appetite, breast tenderness, weight gain, enlargement of the ovaries, and excessive growth of body or facial hair.
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