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F.D.A. Panel Recommends Restrictions on Hydrocodone Products Like Vicodin

F.D.A. Panel Recommends Restrictions on Hydrocodone Products Like Vicodin →

This is the type of policy that sounds good when you think about all of the ways that drugs can be abused. But it completely fails to consider the impact on patients who really need access to Vicodin. For instance, pregnant women cannot safely take ibuprofen (Advil). Women who suffer frequent severe headaches during pregnancy must either take Vicodin or spend months in hell. The DEA and FDA consider that a good bargain. I don't.

Trying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.

The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe.

The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.

This entry was tagged. Drugs