Following is a news release based on a ìViews & Reviewsî article published in the May issue of Neurology, the scientific journal of the American Academy of Neurology (AAN). The AAN is an association of more than 14,500 neurologists and neuroscience professionals dedicated to improving patient care through education and research. For a copy of the full article or for more information, contact Sarah Parsons or Rona Stewart at 612-623-8115 or by e-mail [email protected].
Neurology Views and Reviews Article: ëSafeà Treatment for Migraine Can Cause Addiction Medical professionals and patients are not being informed or warned about the serious dangers associated with a migraine drug, according to an article published in the May issue of Neurology. The lack of information on the increasing incidence of addiction/dependence associated with Stadol NS' (butorphanol nasal spray), manufactured by Bristol-Myers Squibb is largely due to the failure of the Food and Drug Administration to discern and act on the abuse potential of the drug and to recommend further controls to Drug Enforcement Administration, according to the article. After his son committed suicide during treatment for his Stadol' addiction, neurologist Morris A. Fisher, MD, professor of neurology at Loyola University, Stritch School of Medicine, Maywood, IL, and his niece, investigative reporter Stephanie Glass, Fairfield, CT, gathered information for the article through the Freedom of Information Act. The results of his investigation are published as a ìViews & Reviewsî article in Neurology. Views & Reviews articles are review submissions or opinion statements on timely clinical or scientific subjects. Fisher states that evidence showing abuse potential should force the FDA to recommend to the Drug Enforcement Administration (DEA) that the drug be scheduled. Drugs which are scheduled are controlled by the DEA because of their potential for dependence. These drugs are much more closely tracked to prevent diversion into illegal channels. Medical evidence, he says, has always indicated that Stadol' a synthetically derived opioid, is an addictive drug that should be scheduled for both effective control and as a caution to physicians and patients. ìThe failure to do this has caused considerable harm and repeated the well-established pattern of narcotic drug use in the United States,î Fisher writes. This evidence has been accumulating for a long time, according to Fisher. In 1978, as part of the drug approval process, the FDAÃs Drug Abuse Advisory Committee (DAAC) reviewed an injectable form of Stadol. The committee recommended scheduling Stadol' noting its abuse potential and withdrawal symptoms in people who had received the drug during clinical trials. The committeeÃs recommendation was not followed. Arguments against scheduling the drug included patient convenience and decreased commercial potential. Soon after the approval, reports were made to the FDA of abuse and adverse drug reactions including psychological disturbances consistent with narcotic use ñ confusion, hallucinations and paranoid reactions. From during the period 1979-92 adverse drug reactions from Stadol' were reported to FDA at a rate of about 60 per year, six of which annually were reports of dependence/addition, and one death. However, since the drug was largely administered within the confines of hospitals or clinics, ìinterpretation of these reports was that they were not of ëvery great significance.Ãî In 1989, Bristol-Myers Squibb, applied for approval of Stadol' as a nasal spray. The DAAC again discussed the issue of scheduling the drug, including the likelihood of increased abuse potential due to the nasal spray form. In the record of the approval process, Fisher found that the manufacturer argued that there was no new evidence for potential or actual abuse. However, the record also contains evidence for physical dependence on Stadol' with rats, monkeys, baboons, and humans. The FDA review panelÃs conclusion, according to Fisher, was to wait to see if problems arose. Despite the fact that BMS told FDA that Stadol NS' would not be used chronically, Fisher reports that in 1991 after the nasal spray form of the drug, the companyÃs advertising campaign promoted its use for migraine headaches, ìa condition in which repeated long-term use could be anticipated.î Stadol NS' was promoted in advertising materials as a safe pain killer for migraines, with few and minor side effects. Fisher points out that the relatively mild side effects mentioned in Bristol-Myers Squibb product literature stand in stark contrast to reality. The documents he uncovered show that during the first three years after release of the nasal spray, adverse drug reactions reported to the FDA increased from ì60 per year to about 400 per year.î About half were major psychological disturbances or dependence/addiction. Because of the adverse reactions, the FDA sent a memo in 1994 to State Drug Program Directors, Boards of Pharmacies and Drug Enforcement Officials asking for experiences with Stadol. Thirty-one of the 47 responding states were aware of non-medical use, diversion or abuse of Stadol. Over 50 percent instituted special controls to limit access to the drug. These problems surfaced within two years of the release of Stadol NS. Fisher says that physicians rely on the DEA to control addicting prescription drugs and the FDA to keep them informed. ìThe fundamental issue raised by the history of (Stadol') use is the lack of accurate and timely information,î he said. ìFor example, that dependence/addition is by far the most common adverse effect of a drug reported to the FDA is obviously important medical information, but the public is not well-served if meaningful drug information can be obtained only through the Freedom of Information Act. The experience with Stadol' should not be repeated.î
RSS