Texas Children May Be Taking An Unapproved Prescription Opoid
It looks like the Food and Drug Administration (FDA) is in hot water yet again.
Recent revelations that over one hundred manufacturers are making potentially harmful, unapproved prescription opoid-containing medications, and that these drugs are being freely distributed in the United States, has many wary of the administration's ability to oversee drug safety.
Even some children have taken the medications.
According to officials, the FDA has not approved most drugs with the codeine substitute, hydrocodone, to suppress cough.
One of the more powerful medications to treat pain or coughing, hydrocodone has long been known for its high abuse potential.
As with all opoids, overdoses can cause breathing problems, cardiac arrest, impairment of motors skills and judgment, illness, and, in some cases, even death.
It is often used, however, instead of codeine, because it reduces the risk of such negative side effects as nausea, allergic reaction, and gastrointestinal problems.
The FDA, while admitting its mistake, said it is particularly concerned about improper pediatric labeling of unapproved cough suppressants with the ingredient, otherwise known as antitussives.
None should be approved for children under two, officials said, though "there are hydrocodone-containing products on the market that claim they are suitable for children as young as two," according to Deborah M.
Autor, director of the agency's Office of Compliance, Center for Drug Evaluation and Research.
"The FDA is announcing an action to stop the illegal marketing of any unapproved drug containing hydrocodone," she said.
Such actions include stopping manufacturers from making and distributing any unapproved hydrocodone products labeled for children six and under by October 31st of this year.
Makers of other unapproved products with the ingredient must also stop manufacturing them by December 31st, and must "cease further shipment in interstate commerce on or before March 31st, 2008.
" Texas recognized hydrocodone's high potential for abuse fifteen years ago when officials commented that it was a "significantly abused drug" and that forged prescriptions for it were, indeed, a problem.
The Texas Board of Pharmacy petitioned the Board of Health to reschedule all dosage forms of the drug from Schedule III to Schedule II of the state controlled substance act.
Reclassifying it as a Schedule II substance allowed for more restrictions and better monitoring, including the requirement for triplicate prescriptions; implementing this policy on Schedule II drugs influenced a sixty-four percent drop in their prescriptions.
Such abuse problems are difficult issues to address, however.
Pain medications are of vital importance to the Western medical community, and are drugs most health insurance companies cover with the appropriate prescriptions.
"Opoid analgesics are the cornerstone of pharmacological postoperative pain management," according to the Agency for Health Policy and Research.
The World Health Organization, as well, validated narcotics' benefits under controlled conditions, deeming opoids, like codeine and morphine, "essential drugs" that should be made available in all countries to treat certain conditions.
Such open usage, even if well-intentioned, however,has not only helped create the need for large drug rehabilitation centers in cities like Dallas, Austin, and Houston, but has also fueledheated debates over the validity of medical marijuana usage -- a substance still considered federally illegal, but considered legal for medical purposes under several states' laws.
Many studies on marijuana have proven its effectiveness for pain management, but its decreased risk of physical and psychological dependence.
Until that issue is cleared, however, agencies must find a way to regulate far more dangerous and addictive pain relievers, like opoids.
U.
S.
health officials announced their own crackdown on manufacturers of unapproved hydrocodone products on September 28th, vowing to bring the situation under control.
Many of the drugs don't carry the proper warning labels, and have names similar to other medications, they said.
"Product names are so similar that the wrong doses or wrong medication may be dispensed," commented Autor.
On the 27th, President Bush signed a five-year renewal of a law funding the FDA's ability to oversee prescription drug safety, despite a recent searing report of the agency by the inspector general of the U.
S.
Department of Health and Human Services.
The renewal allows for the administration to collect higher fees from drug and medical device makers in an attempt to defray the costs of reviewing products submitted for approval.
It also allows the FDA to take action when there are problems with drugs already on the market, including updating new warning labels.
Daniel R.
Levinson, inspector general of the U.
S.
Department of Health and Human Services, however, may have his doubts about such a renewal.
Levinson reported that the FDA was already having trouble keeping up with its tasks -- that officials did not know how many clinical trials were being conducted at any given time, and that they audited only one percent of clinical testing sites.
Even when they were checked, FDA personnel usually showed up long after tests had been completed, and then rarely followed-up on whether or not sites considered to have serious problems had implemented corrective actions.
Top officials also improved poor assessment scores returned for sites conducting human clinical trials sixty-eight percent of the time.
Levinson's review only adds to the FDA's recent woes over imported food, toys, and drugs.
According to Autor, two percent of all prescriptions in the U.
S.
are for unapproved drugs, and that it is very likely most of the two hundred medications on the market with hydrocodone are for unapproved brands.
Accepted medications with this ingredient include TussiCaps, Tussionex, Pennkinetic, Mycodone Homatropine, Methylbromide, Hycodan, Tussigon, and Vicodin.
Recent revelations that over one hundred manufacturers are making potentially harmful, unapproved prescription opoid-containing medications, and that these drugs are being freely distributed in the United States, has many wary of the administration's ability to oversee drug safety.
Even some children have taken the medications.
According to officials, the FDA has not approved most drugs with the codeine substitute, hydrocodone, to suppress cough.
One of the more powerful medications to treat pain or coughing, hydrocodone has long been known for its high abuse potential.
As with all opoids, overdoses can cause breathing problems, cardiac arrest, impairment of motors skills and judgment, illness, and, in some cases, even death.
It is often used, however, instead of codeine, because it reduces the risk of such negative side effects as nausea, allergic reaction, and gastrointestinal problems.
The FDA, while admitting its mistake, said it is particularly concerned about improper pediatric labeling of unapproved cough suppressants with the ingredient, otherwise known as antitussives.
None should be approved for children under two, officials said, though "there are hydrocodone-containing products on the market that claim they are suitable for children as young as two," according to Deborah M.
Autor, director of the agency's Office of Compliance, Center for Drug Evaluation and Research.
"The FDA is announcing an action to stop the illegal marketing of any unapproved drug containing hydrocodone," she said.
Such actions include stopping manufacturers from making and distributing any unapproved hydrocodone products labeled for children six and under by October 31st of this year.
Makers of other unapproved products with the ingredient must also stop manufacturing them by December 31st, and must "cease further shipment in interstate commerce on or before March 31st, 2008.
" Texas recognized hydrocodone's high potential for abuse fifteen years ago when officials commented that it was a "significantly abused drug" and that forged prescriptions for it were, indeed, a problem.
The Texas Board of Pharmacy petitioned the Board of Health to reschedule all dosage forms of the drug from Schedule III to Schedule II of the state controlled substance act.
Reclassifying it as a Schedule II substance allowed for more restrictions and better monitoring, including the requirement for triplicate prescriptions; implementing this policy on Schedule II drugs influenced a sixty-four percent drop in their prescriptions.
Such abuse problems are difficult issues to address, however.
Pain medications are of vital importance to the Western medical community, and are drugs most health insurance companies cover with the appropriate prescriptions.
"Opoid analgesics are the cornerstone of pharmacological postoperative pain management," according to the Agency for Health Policy and Research.
The World Health Organization, as well, validated narcotics' benefits under controlled conditions, deeming opoids, like codeine and morphine, "essential drugs" that should be made available in all countries to treat certain conditions.
Such open usage, even if well-intentioned, however,has not only helped create the need for large drug rehabilitation centers in cities like Dallas, Austin, and Houston, but has also fueledheated debates over the validity of medical marijuana usage -- a substance still considered federally illegal, but considered legal for medical purposes under several states' laws.
Many studies on marijuana have proven its effectiveness for pain management, but its decreased risk of physical and psychological dependence.
Until that issue is cleared, however, agencies must find a way to regulate far more dangerous and addictive pain relievers, like opoids.
U.
S.
health officials announced their own crackdown on manufacturers of unapproved hydrocodone products on September 28th, vowing to bring the situation under control.
Many of the drugs don't carry the proper warning labels, and have names similar to other medications, they said.
"Product names are so similar that the wrong doses or wrong medication may be dispensed," commented Autor.
On the 27th, President Bush signed a five-year renewal of a law funding the FDA's ability to oversee prescription drug safety, despite a recent searing report of the agency by the inspector general of the U.
S.
Department of Health and Human Services.
The renewal allows for the administration to collect higher fees from drug and medical device makers in an attempt to defray the costs of reviewing products submitted for approval.
It also allows the FDA to take action when there are problems with drugs already on the market, including updating new warning labels.
Daniel R.
Levinson, inspector general of the U.
S.
Department of Health and Human Services, however, may have his doubts about such a renewal.
Levinson reported that the FDA was already having trouble keeping up with its tasks -- that officials did not know how many clinical trials were being conducted at any given time, and that they audited only one percent of clinical testing sites.
Even when they were checked, FDA personnel usually showed up long after tests had been completed, and then rarely followed-up on whether or not sites considered to have serious problems had implemented corrective actions.
Top officials also improved poor assessment scores returned for sites conducting human clinical trials sixty-eight percent of the time.
Levinson's review only adds to the FDA's recent woes over imported food, toys, and drugs.
According to Autor, two percent of all prescriptions in the U.
S.
are for unapproved drugs, and that it is very likely most of the two hundred medications on the market with hydrocodone are for unapproved brands.
Accepted medications with this ingredient include TussiCaps, Tussionex, Pennkinetic, Mycodone Homatropine, Methylbromide, Hycodan, Tussigon, and Vicodin.
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