Xanax – America’s hottest selling tranquilizer – praised by some, condemned by many, has become one of the nation’s most controversial drugs as s result of recent approval for use in the treatment of panic disorder – a sever, though not rare, form of anxiety state disorder.

Documents obtained from the Food and Drug Administration (FDA) by this writer under the Freedom of Information’s Act indicate that no evidence exists that Xanax (a benzodiazepine tranquilizer produced by Upjohn) cures anxiety or panic disorder, nor that it is even safe.

The product does have FDA approval for treating both conditions. However, serious adverse effects were reported even from the short-term clinical trials (less than 10 weeks) that XANAX (alprazolam) was subjected to by Upjohn in order to obtain approval. Panic disorder may be cured naturally without any hazard of adverse drug side effects. The condition is not life threatening, although it leaves its victims often severely disabled in that they often withdraw most activity and live in constant dread of the next panic attack.

Russian Roulette

Xanax is a “therapy” with a great potential for harm. The drug does not effectively resolve the underlying bio-chemical basis of anxiety state disorders. The “evidence” for the FDA approval was obtained from three very short-term studies. Several senior FDA officials have expressed concern that there is no data to suggest that Xanax is safe over a long period or a higher dosages – yet, there are many patients who are being prescribed this drug for months and even years!

Actually, there is compelling evidence that benzodiazepines, particularly XANAX, may be among the most addictive substances in the American drug marketplace. Thomas Temple, M.D., Director of the FDA Office of Drug Evaluation, noted that the potential for XANAX withdrawal phenomena was “clearly the area of main concern for two principal reasons. First, there is the matter of seizures. In addition, there is the issue of life long dependence, i.e., inability to discontinue therapy.”

FDA Psychiatric Drug Products group leader Thomas Laughren, M.D. agreed that much of Upjohn’s information concerning withdrawal events was “often poorly organized and confusing.” The official expressed “frustration that so little useful data have emerged…”

Yet, the FDA has approved this drug in higher dosages (up to 10 mg per day) for the treatment of panic disorder without evidence that it is safe for long-term prescription! At the highest dosage level (6 mg per day) administered in the short\term studies, subjects were having considerable difficulties with adverse effects.

Unsafe At Any Speed

According to the FDA, applications for XANAX in panic disorder have been turned down by Denmark (“…insufficient data to evaluate long term efficacy and safety…”), Germany, and Norway (“…deficiency in long term data to support the safety of XANAX with regard to withdrawal phenomena…”)

What do quotes from the new XANAX (Upjohn) product labeling reveal? “Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder.”

One may well question the motive for not having longer-term scientific data available on a drug that has been aggressively marketed for a decade and that sells for over $800,000 per kilo.

Upjohn admits, “Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure…studies of patients with panic disorder showed a higher rate of rebound and withdrawal symptoms with XANAX…Other symptoms, such as anxiety and insomnia, were frequently during discontinuation…

“The ability of patients to completely discontinue therapy with XANAX after long-term therapy has not been reliably determined…Withdrawal reactions may occur when dosage reduction occurs for any reason…withdrawal symptoms including seizures have been reported after only brief therapy with XANAX at doses within the recommended range for the treatment of anxiety…Death has been reported in association with overdoses in association with overdoses of alprazolam by itself…

Severe Side Effects

“XANAX has the potential to cause sever emotional and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment…The following adverse events have been reported in association with the use of XANAX, seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

“The necessary duration of treatment for panic disorder victims responding to XANAX is unknown…a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.”

A drug with unknown long-term consequences and potential for addiction has been approved by the FDA for a non-life threatening condition, which may be treated successfully by non-drug means!

XANAX has become a major economic success story for the Upjohn Company. Small wonder with its habituating potential and immediate appeal for sufferers of panic and anxiety disorders desperately seeking relief. In the end, the long benzodiazepine tranquilizer voyage is a journey into the darkest side of the twilight zone – another world’s timeless hell for those that are lured there seeking calm, and yet finding unrelenting heightened anxiety and abject misery.

Max Ricketts is a graduate of the US Naval Academy. He is an investigative health writer and the author, with Edwin Bien, M.D., of the Great Anxiety Escape, a revolutionary program to escape from anxiety, insomniac, depressive, and drug related disorders. The book is available for $12.45, postage and handling included, from Matulungin Publishing, P.O. Box 2910, La Mesa, CA 91943. California residents, please add $0.72 sales tax.