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  1. merc11292
    ROCKVILLE, Md., Sept. 28 -- The FDA today ordered makers of more than 200 unapproved hydrocodone-containing cough suppressants to take them off the market, starting the end of next month.
    The unapproved antitussives are prescription products that probably represent the majority of cough syrups prescribed by physicians, said Deborah M. Autor, J.D., director of compliance at the FDA's Center for Drug Evaluation and Research (CDER).

    There are only seven FDA-approved hydrocodone-containing cough syrups, she said, so it is likely that the majority of prescriptions are for unapproved products. Moreover, many of the unapproved products have names much like one another or very similar to approved products, which may be confusing to physicians, pharmacists, and patient.

    Autor said the FDA was giving the drug makers until Oct. 31 to stop the marketing and distribution of unapproved hydrocodone cough syrups that are labeled for use in children younger than six. The companies have until Dec. 31 to stop making the products and until March 31, 2008, to stop interstate shipment.

    The announcement marked the latest action in an FDA campaign, launched in June 2006, against unapproved drugs.

    In most cases the products have been sold for decades, but in the 1960s Congress authorized the FDA to review drugs marketed from 1938 through 1962 to determine both safety and efficacy. In 1982, a hydrocodone cough syrup was reviewed as required by the Drug Efficacy Study Implementation (DESI) "and it was found to be safe and effective," Autor said. As a result of that action, all other hydrocodone cough syrups were required to submit to DESI review.

    Seven companies did receive FDA approval for their products, but the rest -- more than 200 -- simply continued to market their products without approval. "They just took the shortcut," Autor said.

    The seven approved hydrocodone-containing cough suppressants are:
    • TussiCaps made by Tyco
    • Tussionex/Pennkinetic by Celltech
    • Hydrocodone compound by Actavis Mid Atlantic
    • Mycodone by Morton Grove
    • Homatropine methlybromide and hydrocodone bitartrate by Actavis Totowa
    • Hycodan by Endo Pharmaceutical
    • Homatropine methypromide by King Pharmaceutical.
    Michael Levy, director of the division of new drugs and labeling compliance at CDER, said there had been reports of deaths associated with use of the unapproved products, although he didn't indicate how many deaths or associate them with a specific unapproved product.

    Asked for clarification, Jason Woo, M.D., M.P.H., associate director for medical and scientific affairs at the office of compliance, said the FDA had received "more than 400 spontaneous reports of adverse events" with hydrocodone-containing antitussives, "but had not sorted out the reports by approved or unapproved status."
    Moreover, Autor said the FDA has no evidence to either prove or disprove the efficacy and safety of the 200-plus products. It was possible, she said, that the products were safe and effective, but the FDA has no data to decide.
    Makers of the unapproved cough syrups still have the option of submitting products to the FDA for DESI review, she said.
    Physicians or patients who have questions about the approval status of hydrocodone cough suppressants can check the FDA's website for a listing of approved and unapproved products, Autor said.

Comments

  1. merc11292
    Someone told me they saw something on the news about it, but this was all i could find.
  2. beentheredonethatagain
    FDA to stop some hydrocodone

    [​IMG]

    FOR IMMEDIATE RELEASE
    September 28, 2007


    FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products
    Action to impact approximately 200 cough-suppressant products

    The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other hydrocodone formulations, which have FDA approval.
    Hydrocodone is one of the strongest medications available to treat pain or to suppress cough. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.
    The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. As part of the drug approval process, the agency considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.
    Some hydrocodone pain-relief products, such as Vicodin, are FDA-approved. However, most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.
    "Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "A case in point – no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age."
    Today's action is part of FDA's broader initiative on marketed unapproved drugs that was announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA's risk-based enforcement approach to these products.
    "This is another example of the kinds of safety risks that warrant priority enforcement under our Compliance Policy Guide," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "There are products on the market with inadequate safety information on their labeling improperly suggesting that the products may be used safely by very young children. In addition, these products may pose a higher risk of medication error than approved products. These products need to come off the market until they meet FDA approval standards."
    There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. There are seven FDA-approved cough suppressant products containing hydrocodone. There also are a variety of approved antitussive products that do not contain hydrocodone. Consumers should consult a health care professional for detailed guidance on treatment options.
    Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007 and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.
  3. toe
    Re: FDA to stop some hydrocodone

    There really doesn't seem to be any arguing with this point. I mean, is anyone going to argue in favor of inducing respiratory depression in small children?

    I'm curious about all these "unapproved" products, though. The article makes it sound as if there is black market hydrocodone cough syrup on pharmacy shelves, doesn't it? How does a prescription drug wind up being marketed if it has no FDA approval for any use? I know pharmcos are commonly enough reprimanded for promoting off-label (non-approved) applications of their drugs- but those drugs don't wind up on the market until they've been approved for something.

    Very confused.

    Duh, there were aftermarket formulation changes.
  4. radiometer
  5. beentheredonethatagain
    Re: FDA to stop some hydrocodone

    I believe you are correct , thinking codeine is next along with robotusin and other dxm containing medicines, good point Radiometer
  6. Heretic.Ape.
    Re: FDA to stop some hydrocodone

    ^^^ For now I would venture dextromethorphan is fairly safe due to it's long standing exemption from such matters... but you never can tell. A few more stories of the poor children getting hooked and hurting themselves and we'll see.
  7. beentheredonethatagain
    Re: FDA to stop some hydrocodone

    yes, like in the 1960's news reports of LSD causing youths jumping from buildings because the "bad" trip of an acid trip. We know that only a very few did such a stunt, the majority of people who did take LSD had a very good and mind opening expeirence. The so called straight laced people usually regular drunks, had to come up with some reasons to put the lid on something that caused them unease. for no other reason than that
  8. Euphoric
    http://news.yahoo.com/s/nm/20071011/us_nm/usa_recall_coldmedicine_dc

    [h1] Drugmakers recall infant cough/cold medicine in U.S.[/h1]
    CHICAGO (Reuters) - Johnson & Johnson . Wyeth and other makers of infants' nonprescription cough and cold products are recalling certain medicines in the United States because of the danger of overdose, the Consumer Healthcare Products Association said on Thursday.

    Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines, as well, because data show that when the medicines are misused, it can lead to overdose, especially in children under the age of 2 years.


    A spokeswoman for Consumer Heathcare, a trade association representing the makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances.


    The recall comes ahead of an October 18-19 meeting of outside experts who will make safety recommendations to the U.S. Food and Drug Administration.


    Questions have been raised for more than a year about the safety of the use of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.


    Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.


    Many say there is little evidence that these medicines are effective in such young children anyway and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.


    Medicines that are being recalled from the U.S. market include: Concentrated Infants' TYLENOL Drops Plus Cold; Concentrated Infants' TYLENOL Drops Plus Cold & Cough; PEDIACARE Infant Drops Decongestant (PSE); PEDIACARE Infant Drops Decongestant & Cough (PSE); PEDIACARE Infant Dropper Decongestant (PE); PEDIACARE Infant Dropper Long-Acting Cough; PEDIACARE Infant Dropper Decongestant & Cough (PE) products; Dimetapp Decongestant Plus Cough Infant Drops; Demetapp Decongestant Infant Drops; Little Colds Decongestant Plus Cough; Little Colds Multi-Symptom Cold Formula; Robitussin Infant Cough DM Drops; Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.
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