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FDA finally considering tighter restrictions on hydrocodone-combination drugs like Vicodin
After more than 13 years of often bitter wrangling among various interest groups, the Food and Drug Administration (FDA) may finally tighten restrictions on hydrocodone-combination painkillers like Vicodin, Lortab and Norco, moving them up from ‘Schedule III’ to the more tightly controlled ‘Schedule II.’
Hydrocodone-combination painkillers contain hydrocodone and some form of acetaminophen (or paracetamol). Hydrocodone is a leading cause of addictions and deaths. But acetaminophen overdoses result in at least 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths each year. So there’s more to the risk than just the opiate hydrocodone.
Under the new schedule, doctors would be required to actually write all prescriptions, rather than just call them in without seeing a patient. And they would only be allowed to prescribe three months worth of doses, rather than the six months allowed under the current Schedule III.
Opponents of the plan say that “up-scheduling”, as it’s called, hydrocodone combination meds from Schedule III to II, would deny patients access to their meds. On the other hand, supporters of the plan say it’s more important to reduce the terrible epidemic of Vicodin addiction and ruined lives.
Supporters want to reduce hydrocodone addiction
Supporters include consumer and patient safety associations, many concerned physicians and the Drug Enforcement Agency (DEA). On the opposing side are the drug companies, some pharmacists’ groups and some medical associations. While supporters are concerned about the safety of patients and reducing hydrocodone addiction, the opposition seems to be more about the potential for less income, since there’s no hard data to back up their claims that it would impact patient access.
Supporters say the new rules won’t create insurmountable hardship for patients, because the pills are there for prescribing as usual, and all that’s being asked is a little more attention from doctors and pharmacists. They remind us that prescriptions are required for all other similarly dangerous drugs – and hydrocodone is a dangerous drug – require doctor visits and written prescriptions. And few patients, if any, are complaining about it.
Hydrocodone biggest killer in Florida
Here in Florida and in many other states, hydrocodone leads the list of death-dealing drugs – far ahead of oxycodone and OxyContin. In fact, hydrocodone is the most-prescribed drug in the entire country. Hydrocodone accounted for 131 million prescriptions, for 47 million patients, in 2011 – far ahead of the cholesterol drug simvastatin, in second place with 94 million prescriptions.
Way back in 1999, the former director of an addiction treatment center in Syracuse, N.Y., petitioned the FDA to raise restrictions on hydrocodone combination drugs like Vicodin, Lortab and others. The drug had exactly the same reputation as oxycodone, especially among law enforcement and emergency room personnel. Since then, more consumer groups, physicians and even the DEA have all called repeatedly for up-scheduling of hydrocodone.
Until now the FDA has largely ignored the evidence against Vicodin
The FDA, on the other hand, has largely ignored legal and medical evidence and advice, even from its own people. In 2009, an FDA advisory panel recommended removing Vicodin from the market because of its danger to the public. Now, after two days of hearings this past January, a new advisory panel has recommended that the FDA take steps to reschedule hydrocodone combination drugs to Schedule II.
In spite of all the arguments against it, Schedule II controls just don’t sound as if any legitimate patients would unduly suffer. Novus Medical Detox Center is a leader in the field of drug treatment, with years of experience handling Florida hydrocodone detox. We cast our vote for tightening up the restrictions on hydrocodone combination drugs like Vicodin, Lortab and Norco, because we’ve seen the damage these drugs can do.
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