It seems that the Food and Drug Administration (FDA) is in hot water again. Recent revelations that manufacturers more than a hundred are potentially dangerous, unapproved prescription medicines containing opoid and that these medicines are freely be distributed in the United States, a lot to keep the administrative capacity to monitor the safety of medicines. Even some children have taken drugs.
According to officials, the FDA has not approved most medications with codeine, hydrocodone, to remove the cough replacement. One of the most powerful medicines to treat pain or cough, hydrocodone has long known for its high potential for abuse.As with all opoids overdoses can cause respiratory, cardiac arrest, reached skills engines and judgment, disease and, in some cases, even the mort.Il is often used, however, instead of codeine, because it reduces the risk of these side effects as of nausea, an allergic reaction and gastrointestinal problems.
FDA, while recognizing its error, said that it is particularly concerned about inappropriate to unauthorized with the ingredient cough suppressants, also called Pediatric antitussives.Aucun labelling should be approved for children of less than two officials said, although "it y hydrocodone containing products on the market who claim that they are suitable for children from the age of two," Deborah M. Autor, Director, Office of the Agency, compliance function centre research and evaluation of drugs. "The FDA is announcing an action to stop illegal marketing of any non-approved drugs containing hydrocodone", she says.
These actions include manufacturers making and distributing unapproved hydrocodone products labeled for children six and under shutdown by 31 October of this year. Responsible other products is not allowed with the ingredient must also stop their production by December 31 and "more stop shipment in interstate it commerce the or before March 31, 2008.".
Texas recognized high potential of hydrocodone abuse fifteen years ago when officials commented that it was a "substantially harmed drug" and that forged prescriptions that were, in effect, a problem. Pétitionné Texas Pharmacy Council Council health of all forms of dosage of drugs in annex III to annex II rescheduled State controlled substances Act. This reclassification as a substance of annex II allowed over restrictions and better monitoring, including the requirement for the triple prescriptions; updated implementation of this strategy on drugs for Annex II influenced a drop of soixante-quatre per cent in their prescriptions.
These problems of violence are difficult questions to address, cependant.Douleur medicinal products are of vital importance to the medical community West and cover most of health with the appropriate requirements insurance companies are drugs. "Opoid analgesics are the cornerstone of the pharmacological post-operative pain management" according to the Agency for research and health policy. The World Health Organization, posted benefits narcotics under controlled conditions, deeming opoids, such as codeine and morphine, "essential drugs" that should be made available in all countries to deal with certain conditions.Use open, even if well-intentioned, however, has not only assisted in creating the need for rehabilitation centres large drug cities as Dallas, Austin and Houston, but has also fueled debate animated on the validity of the use of medical marijuana - always considered as illegal by Federal substance but regarded as legal medical pursuant to the laws of several États.De numerous studies on marijuana proved its efficiency for the management of pain, but her risk of reduction in the physical and psychological dependence.
However, until this issue is disabled, agencies must find a way to regulate the most dangerous and addictive analgesics as opoids.U.S.health officials announced their repression to manufacturers of products hydrocodone unapproved on September 28, vowing to make the situation under control.Most medicines not carry labels appropriate warning and have names similar to other drugs, they said."Product names are so similar erroneous dose or wrong medication may be exempt," says author.
27, President Bush signed a renewal of five years as a financing capacity of FDA law to oversee the safety of prescription despite a frenzied recent report of the Agency by the Inspector General of the US Department of health services and renewal sociaux.Le allows the administration to collect the highest cost of drugs and medical devices manufacturers trying to cover the costs of examination of products subject to the approval.It also allows the FDA action when there are problems with drugs already on the market, including the update of new warning labels.
Daniel r. Levinson, Inspector General of the US Department of health and social services, however, may have his doubts about one such renouvellement.Levinson reported that FDA has been having already badly to keep its tasks - that officials knew not how many clinical trials were conducted at a given time, and that they checked only one per cent of tests cliniques.Même sites when they have been verified, personal FDA generally have long after the tests had been completed and then rarely followed-up on or not the sites considered as having serious problems had implemented actions correctives.Hauts officials has also improved scores poor assessment returned for sites conducting human clinical trials soixante-huit per cent of the Levinson temps.Examen adds only to headaches recent FDA on imported foods, toys and drugs.
According to the author, two percent of all requirements applicable to us are non-approved drugs and it is very likely most medicines on the market with two hundred hydrocodone are trademarks not approuvés.Médicaments accepted with this ingredient include TussiCaps Tussionex, Pennkinetic, Mycodone Homatropine, METHYLBROMIDE, Hycodan, Tussigon, Vicodin.
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