FDA orders controls on apparently addictive migraine drug
Jun. 15, 1997
WASHINGTON (AP) _ Bruce Fisher was overjoyed to finally find a drug that almost instantaneously snuffed out his severe migraines. But the Illinois man became hooked on the seemingly innocuous nasal spray _ and at age 24, in the midst of addiction therapy, he shot himself to death.
Now, after hundreds of reports of patient dependence, the Food and Drug Administration has recommended that the popular migraine drug Stadol be classified as a controlled substance, to curb how doctors prescribe it.
The Drug Enforcement Administration says the new restrictions, on both the shot version hospitals provide and the popular nasal spray Stadol NS, will be in force within months.
That's too late for Chicago neurologist Dr. Morris Fisher, who despite his own medical expertise had no inkling Stadol could be addictive until his son was in trouble. He argues in this month's journal Neurology that neither the FDA nor Stadol's manufacturer adequately warned doctors or patients about what they knew was a mounting problem.
``The evidence would raise some questions about their having acted in the best interests of patients or physicians,'' Fisher said.
Manufacturer Bristol-Myers Squibb vehemently disagrees. In February 1995 _ six months before the younger Fisher's death _ it recommended to the FDA that the Stadol nasal spray be reclassified a controlled substance.
Still, ``I don't think we have a problem,'' the company's medical director, Dr. Darlene Jody, contended. ``Our data suggest that very few patients who have been prescribed Stadol NS have had problems with abuse or addiction.''
The FDA has received reports of 41 deaths and 774 addiction-associated side effects possibly involving Stadol.
The injectable version, sold since 1978, accounted for some. But for the nasal spray, the FDA lists 654 addiction-associated reactions and 18 deaths _ seven associated with drug abuse or addiction.
The spray was approved for marketing only in 1991.
The nasal spray, which Fisher wrote is five times more potent than the injection, accounts for the vast majority of Stadol's estimated $100 million in annual sales.
Every week, Dr. Joel Saper of the Michigan Head Pain and Neurology Institute hospitalizes two to three Stadol addicts who seek help from around the country.
Very few abuse Stadol for the ``buzz'' it gives certain users, he said. Instead, the problem is unique to migraines: The more painkillers some sufferers take, the more headaches they actually get. This ``rebound syndrome'' causes them to take enough Stadol to get hooked.
``Here is a drug that really works for some people,'' Saper said. ``The problem is doctors were not aware of the physical dependency risks,'' which would have warned them to withhold Stadol from patients with frequent migraines.
Marla, an Iowa mother, was hospitalized after she went from using the prescribed dose of Stadol NS two days a week to needing an entire $70 bottle every five days.
``You do what you do to function,'' explained Marla, who spoke from her Ann Arbor hospital room on condition that her last name not be used. ``It works almost immediately. Within 15 minutes your pain is starting to be relieved. But it's very easy for people to get out of hand with it.''
Stadol was especially developed to be less addictive than such narcotics as morphine. The FDA originally thought Stadol wouldn't be a problem because increasing doses _ a major sign of abuse _ can cause unpleasant reactions in many patients.
But seven states already have made Stadol a controlled substance.
The DEA curbs will limit how often doctors prescribe Stadol and how many refills patients get. The FDA also is considering whether to warn doctors officially of the addiction potential.
The danger may not be sufficient to warrant such an expensive, intrusive move, FDA addictive drugs chief Dr. Curtis Wright said.
The FDA started investigating Stadol in 1994. By then, 39 states had reported abuse ranging from forged prescriptions to street sales, Fisher discovered by viewing FDA files through a Freedom of Information request.
When Bristol-Myers agreed for the nasal spray to be controlled in February 1995, the DEA responded that legally it would have to curb the shots too. Last May, Bristol-Myers agreed, and the FDA made the recommendation formal in September.
Fisher doesn't understand the delay and says doctors need the addiction warning now. He notes that FDA just last April had to warn Bristol-Myers to rewrite a promotional brochure that said Stadol NS had ``low potential for abuse.''
Bristol-Myers' Jody insists Stadol does have low potential _ compared to morphine. And the FDA's Wright notes that language explaining all that is in the drug's official labeling that doctors are supposed to read, albeit on the last page.