Nearly 25 million Americans suffer from the debilitating pain of migraine headaches. It can be excruciating, leaving sufferers desperate for relief. So when a painkiller called Stadol became available in an easy-to-use nasal spray, it provided many not only with relief, but with a sense of hope as well.  Stadol Nasal Spray, manufactured by Bristol-Myers Squibb, hit the market in 1992. It's a powerful drug, five times as potent at pain relief as morphine. At the time, the manufacturer told the U.S. Food and Drug Administration that Stadol had little of the addictive qualities of other narcotics. Stadol, said Bristol-Myers Squibb, was a different kind of narcotic, "remarkably safe," with an "extremely low" potential for abuse. Their claims were backed by the FDA, which decided to allow doctors to prescribe Stadol without any government controls. Last year, Stadol Nasal Spray hit nearly $140 million in sales in the United States alone.

Contrary to the manufacturer's claims, in the last few years it has been revealed that the synthetic opiate in Stadol is extremely addictive and has been blamed for several deaths.

To the many who have become addicted, getting off Stadol can be a nightmare.

One spray of Stadol is equivalent to 37.5 milligrams of (the narcotic) Demerol.

When a drug is scheduled-or classified as a controlled substance-by the government, it serves as a red flag to doctors, pharmacists and patients to be on guard about its addictive potential.
    
To find out why Stadol hit the market without any controls, you have to go back nearly 20 years, to 1978, when the FDA initially reviewed Stadol. The drug was then to be used in an injectable form, mainly in hospitals and typically for postoperative pain.

The FDA's own advisory committee had voted overwhelmingly 12 to 2  to schedule the drug as a controlled substance. But in an unusual step, the FDA disregarded the advice of its own committee and allowed Stadol to be marketed as an unscheduled drug.

In December 1991, Bristol-Myers Squibb won FDA approval to sell Stadol in a new, much more accessible form: a nasal spray.
The company's application to the FDA stated that the nasal spray was not be used chronically  for a prolonged period. But it immediately began to market it aggressively for migraines, which are frequently a chronic condition, requiring repetitive use. For many migraines sufferers, the drug did provide relief, and sales began to soar, jumping 600 percent from 1992 to 1995.

The FDA has logged reports a significant amount of deaths and severe addictions associated with the drug. An injectable version took the blame in some of those cases. However the nasal spray has brought most of the complaints. The spray has been linked to hundreds of cases of addiction and numerous deaths.

In February 1995, Bristol-Myers Squibb itself wrote the FDA requesting that it schedule the nasal spray as a controlled substance because of a "modest number of reports of inappropriate use" of Stadol. Yet, at that same time, some of the company's marketing material aimed at patients contained no mention of Stadol's addictive properties.
For Bristol-Myers, the request to control Stadol NS and restrict its sales was unprecedented. By making a drug a controlled substance, makes it more difficult for doctors to prescribe and may prompt some to choose another painkiller.

The question arises as to why Bristol-Myers Squibb did not initially recommend Stadol NS to be labeled as a controlled substance and why the company worked hard to argue the drugs non-addictive benefits to FDA.

Only when one turns to the detailed language in the package insert for the nasal spray is there a warning. It reads: "Special care should be exercised in administering Stadol to emotionally unstable patients and to those with a history of drug misuse. When long-term therapy is necessary, such patients should be closely supervised."

The FDA failed to act, despite a growing number of reports of "drug dependence" submitted by physicians. Among other things, FDA documents state that "addiction appears to develop rapidly from Stadol and that abstinence from Stadol was very difficult."

The FDA still refused to act. Instead, the agency sent a memo about Stadol to the states, suggesting "abuse problems would be best managed by the states."  More than two years after Bristol-Myers Squibb's request to the FDA, Stadol remains an uncontrolled substance. Finally the FDA did request that the federal Drug Enforcement Agency place controls on the drug.

    

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