How the FDA Is Sleeping Through the Xanax Epidemic

Xanax isn't the most dangerous prescription pill on the market, but the anti-anxiety drug is so addictively powerful that doctors are starting to treat the benzodiazepine medicine as if it were an epidemic in itself. That's increasingly a problem for Pfizer (PFE), which makes the branded version of the drug, the 11th most-prescribed product in the U.S. The company has already signaled it may need to take an asset writedown on the declining fortunes of Xanax.

More broadly, the FDA might want to look at why the drug abuse and dependence warnings it requires on the drug are not of the high-profile "black box" kind that it applies to drugs that carry serious health risks. One of the side effects of Xanax, after all, is that it can make later panic attacks worse than the ones the patient is trying to get rid of.

Doctors at the Seven Counties Services clinic, which serves 30,000 patients in Louisville, Ky., got so tired of listening to addicts try to get the drug from them that they stopped prescribing it completely in April and want to wean all their patients from it by year's end. The New York Times' story -- which notes there was an 89 percent increase in emergency room visits nationwide related benzodiazepine use from 2004 to 2008 -- actually underplays the extent of the Xanax problem.

Like OxyContin and Fentanyl, Xanax has become one of the addictive highs of choice in middle America. According to DrugCite, which sifts the FDA's adverse event database, Xanax is responsible for:

199 overdoses
156 losses of consciousness
110 intentional overdoses
98 completed suicides
83 comas
76 deaths

That's not as spectacular as OxyContin/oxycodone (1,057 deaths), fentanyl (1,147 deaths) or Vicodin (291 deaths), but overdosing is common enough to litter the headlines of newspapers in smalltown America:

Jackson County, OH: Two brothers found dead amid empty Xanax bottles.
Palm Desert, Calif.: 21-year-old died of a Xanax overdose.
Mount Pleasant, Wisc.: Police rescue young woman from an overdose.
Lorain, O.H.: Woman charged with possession of Xanax while driving with her baby in the back of the car.
Shelton, Conn.: Woman charged with possession of Xanax after fatal overdose of her boyfriend.
Greenwich, Conn.: Two arrests in Xanax-related overdose death.
Bergen County, N.J.: 25-year-old son of a pharmacist arrested for Xanax possession and forging prescriptions. His brother died of an overdose four years earlier.

Actress Winona Ryder once OD'd on the drug, comedian Sarah Silverman took 16 a day when she was a teenager, and Casey Anthony's father believes Xanax may have played a role in the death of her daughter, Caylee Anthony.

Patchwork enforcement
There have been only patchwork attempts to control the supply of Xanax and its generic versions. Atlanta is considering a ban on new "pill mill" clinics, joining Georgia counties Marietta, Woodstock, Cartersville, Milton and Kennesaw, which have all at one time or another suspended licensing of new clinics.

Pfizer said last year that it may take a writedown on the $1.4 billion "carrying value" of the Xanax brand if sales decline further. (The drug is not a significant sales earner for the company.) That would almost certainly happen if the FDA tightened its enforcement around the drug. While the FDA has issued warning letters to doctors and websites advertising illegal supplies of Xanax, it does not require a "black box" warning on the drug.

No black box
That type of warning is the most serious the FDA can require, and it puts the warning at the top of the drug's prescribing information so that doctor and patient know it's among the most important information about the drug. The FDA does require a warning for addiction on Xanax, but that warning is only at the level of all the other side effects that Pfizer and other makers must alert patients to in their advertising. There is a petition to persuade the FDA to add a black box warning to all benzodiazepines.

That's why Pfizer's Xanax XR web site downplays addiction. Sure, the warning is there, in small gray type at the bottom of the web page, but it's buried amid other less serious warnings about sleepiness and not operating heavy machinery. The page also offers a "Xanax Doctor Discussion Guide," which patients are supposed to fill out and hand to their doctors. The last three questions on it are:

Is Xanax XR right for me?
Can I take Xanax XR with other medicines?
What else do I need to know about Xanax XR?

It might be useful if that guide were to mention in a slightly larger typeface that discontinuing Xanax can lead to sudden, repeated seizures. And the guide doesn't mention at all the reason it is so addictive: quitting Xanax can lead to panic attacks that are even worse than the "baseline" ones the patient came in with. Worse, Pfizer hasn't "systematically" studied how bad Xanax rebound effects are, according to the drug's official prescribing information. The FDA might require Pfizer to start there.
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Image by Isaac Schlueter, CC.

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