In a report to federal regulators, the manufacturer of buprenorphine has provided the starkest evidence to date that misuse of the drug is growing in parts of the country where it is most widely prescribed as an addiction treatment.
Reckitt Benckiser Pharmaceuticals Inc. outlines problems such as a rise in the number of children sickened by accidentally ingesting the pills; an increase, in some areas, of people taking the drug to get high; and commonplace street sales in some cities for as little as $2 per tablet.
The U.S. Food and Drug Administration received the report Jan. 8. A spokesman for the agency said it is under review but declined to comment further. If federal officials conclude that abuse of the drug has become a problem, they can seek further controls over its distribution.
The report linked misuse and illicit sales to the federally sanctioned practice of allowing doctors to prescribe large quantities of the drug for patients to take at home. "It was the patients in treatment for opioid abuse - no doubt selling or trading their own supply of buprenorphine - who were seen as major contributors to the street supply," the report stated.
Federal officials didn't anticipate such abuses when they spent $26 million to develop the drug and help Reckitt Benckiser bring it to market. Congress considered buprenorphine, sold mainly in the U.S. as Suboxone, the centerpiece of its plan to broaden access to addiction treatment.
The latest report closely parallels the findings of a series published in December in The Sun, which revealed that while buprenorphine has been shown to be highly effective as an addiction treatment, its misuse is increasing. The newspaper also identified patterns of illegal sales as well as several deaths caused by taking the drug in combination with other substances.
Many specialists in addiction medicine believe that in the five years the drug has been on the market, its benefits have outweighed any problems. That's also the view of Baltimore's health commissioner, Dr. Joshua M. Sharfstein, who has asked the General Assembly for $5 million to expand buprenorphine treatment for heroin addicts.
Reckitt Benckiser submits the reports as part of a "post marketing surveillance" system as a condition of the FDA's 2002 approval of the drug. The surveillance, conducted by a consultant hired by the company, is intended to alert U.S. regulators to any abuse. A copy of the document was obtained by The Sun.
