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Fentanyl Deaths - Severe Math Problems At FDA

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Describing fentanyl as a "very strong narcotic," on July 15, 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of 120 deaths in patients using the patch for pain management, stating that some patients and doctors might not be fully aware of its dangers.

A cursory investigation of drug deaths listed in various databanks around the country indicates a severe math deficiency in officials within the nation's safety agency because the number of deaths attributed to fentanyl is far larger than the mere 120 cited by the FDA.

For instance, in the year 2004, fentanyl patch abuse was found to be responsible for 115 deaths in Florida alone, according to research conducted by University of Florida toxicologist Dr Bruce Goldberger.

The patches are intended for the relief of chronic pain that requires treatment around the clock and cannot be controlled by other narcotics. The patches contain fentanyl in gel form and can provide up to three days' relief from severe pain,

The products under scrutiny, include the brand name patch, Duragesic, the generic patch manufactured by Mylan Laboratories, and Sandoz, the generic patch manufactured by the Alza Corporation, the same company that manufactures Duragesic for Johnson & Johnson.

An overdose of fentanyl can put a patient into a coma and shut down breathing. Removing the patch will not reverse the effects because the drug builds up in the patient's system and can continue to be absorbed from the skin for up to 17 hours or more.


The FDA advisory warns that people wearing the patches may suffer overdoses or other serious side effects if they drink alcohol, have an increase in body temperature or are exposed to heat from sources like hot tubs, saunas, heating pads, electric blankets, heat lamps, or heated water beds.

The FDA says doctors should prescribe the lowest effective dose of the medication, and that patches should not be used to treat short-term pain, or pain after an operation.

According to the Drug Enforcement Agency, fentanyl was first synthesized in Belgium in the late 1950s and has about 80 times the potency of morphine. "The biological effects of the fentanyls are indistinguishable from those of heroin, with the exception that the fentanyls may be hundreds of times more potent," the DEA's web site reports.

In the latter part of the1970s, fentanyl began appearing in designer drugs. The term "designer drug" was first coined in California to describe the private synthesis of drug analogs slightly different from their parent compounds, that by design rendered them temporarily immune from control by the DEA.

The fentanyl analogs were first developed and marketed as a substitute for heroin. The most frequently used fentanyl analog was given the street name China White but others were called New Heroin, Tango and Cash, and Goodfella.

Whether it was because of the drug's strength or its unknown pharmacological properties, users of China White suffered a high number of fatal overdoses, while many people who took New Heroin developed symptoms similar to Parkinson's disease.

In the late seventies, deaths began to mount in heroin users on the West Coast who had purchased "China White." The illicit marketing of fentanyl products ultimately caused more than 100 overdose deaths on the West Coast by 1986, according to Designer drugs: past history and future prospects, J Forensic Sci 33:569-575, 1988.

In 1991, the analog Tango and Cash was implicated in at least 28 deaths, primarily in the northeast area of the country. Fentanyl gained widespread attention the same year, when 12 people in New York, Connecticut and New Jersey overdosed and died in a single weekend.

In 1992, China White was determined to be the cause of death in 21 overdoses during a 2-month period in Philadelphia.

Fentanyl gained international notoriety in 2002, when authorities in Moscow, ended a hostage crisis at a theater by pumping an aerosol version of drug into the building, intended to put the nearly 800 hostages and their captors to sleep. In the end, 129 hostages and 41 terrorists died from breathing the gas.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
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On the positive side (which was not mentioned in ... by apaulling on Wednesday, Mar 29, 2006 at 10:53:50 AM
Evelyn Pringle's biased and unscholarly report on ... by John on Wednesday, Mar 29, 2006 at 11:30:30 AM
In the case of most chronic pain patients, many ar... by SacredSalt on Monday, Apr 3, 2006 at 11:09:48 AM