Suit says nasal spray made migraine sufferer an addictJul 9, 1999 | Bergen Record An Upper Saddle River woman has filed suit against a New Jersey pharmaceutical company, claiming she became addicted to a nasal spray prescribed to treat her migraine headaches.
The suit by Annette Nurkin, 36, is the latest in a series of legal actions surrounding the drug Stadol, which was first marketed by the Bristol-Myers Squibb Co. as a nasal spray pain reliever in 1992.
Nurkin, who the suit claims had no history of drug abuse, checked herself in to a drug rehabilitation facility to overcome the dependency.
She began using the nasal spray in spring 1997. "Within months, she began to experience addictive tendencies to this drug," said the suit, filed this week in state Superior Court in Hackensack.
The suit says Nurkin suffered "hot and cold flashes, mild tremors, crying, weight loss, [and] increased headaches" while she took the drug. After about six months, the suit claims, she checked into Good Samaritan Hospital in Suffern, N.Y., for a weeklong treatment.
The suit charges that by February 1995, the Princeton-based drug company was aware that "addiction to Stadol was widespread [and] appeared to develop rapidly, and that discontinuing use of Stadol was very difficult."
Despite this knowledge, the complaint says, the company "failed to add a warning to the drug and continued to aggressively market Stadol for migraine sufferers."
Patrick Donohue, associate director of public affairs at Bristol-Myers Squibb, said Friday that his company had cooperated with the Food and Drug Administration and the Drug Enforcement Administration to have Stadol made a Schedule IV controlled drug. That was done in October 1997, just a fortnight before Nurkin checked herself in for treatment.
Stadol was first sold in 1978 as an injectable pain reliever, and the nasal spray was marketed 14 years later. Now the label's fine print warns that the drug could cause drowsiness or dizziness and that physicians should use special care in prescribing the medication "to patients with a history of drug abuse or to patients receiving the drug on a continuous basis for an extended period."
Physicians should follow "proper patient selection," Donohue said.
Donohue said his company has not seen the Bergen County lawsuit and could not comment on that specifically. Although several lawsuits have been filed nationwide, he said, an attempt to create a class-action suit in Chicago failed.
"Some were dismissed," Donohue said. "Some may have been settled or otherwise resolved." Traditionally, he said, settlement cases remain private.
The drug came under media scrutiny in 1995 when a law student from Miami reportedly became addicted to the medication and committed suicide.
Donohue noted, however, that Stadol continued to be sold as a "potent medication that is used in the management of pain."
Although Stadol is commonly prescribed for use during acute migraines, Donohue said, it also is used for pain relief after surgery or for broken bones.
"We believe Stadol is a safe and effective product," Donohue said. Still, he noted, the medication should be "taken as prescribed by the physician."
Brad Stone, of the public affairs department of the Food and Drug Administration, said reports of deaths or addictions stemming from use of Stadol could be obtained only through a Freedom of Information request.
Nurkin has suffered from migraines since she was 5, said her attorney, John J. Scura. He said the headaches were so severe she was forced to lie in a darkened room. Then her doctor prescribed Stadol.
"It did help," Scura said. "It did relieve the migraine pain, but you have to keep pumping the stuff."
Since her hospitalization, Scura said, Nurkin has struggled with the addiction again.
"She's like a yo-yo," he said. "She's up and down."