U.S. Food and Drug Administration Medication Alert (April 1, 2007)
FOR IMMEDIATE RELEASE TO PHYSICIANS AND CLINICAL PERSONNEL
The U.S. Food and Drug Administration is issuing a Medication Alert to all physicians and clinical personnel currently employed in the U.S. and serving the general public or U.S. Military personnel (active and retired).
The recent death of celebrity Anna Nicole Smith has been identified as an accidental drug-induced fatality. Upon investigation, the following drugs were found in Anna Nicole Smith's body during the autopsy, according to the Broward County medical examiner:
Brand name (drug) indication
Ativan (lorazepam): anti-anxiety medication
Cipro (ciprofloxacin): antibiotic
Klonopin (clonazepam): anti-seizure medicine also used to treat anxiety
Methadone: strong painkiller, often used to suppress withdrawal from heroin
Noctec (chloral hydrate): sedative and sleeping medication
Robaxin (methocarbamol): muscle relaxant
Soma (meprobamate): muscle relaxant
Topamax (topiramate): anti-seizure medication also used to treat migraines
Tylenol (acetaminophen): pain reliever
Valium (diazepam): anti-anxiety medication, also used as a sedative and to treat seizures
She had also taken these around the time of her death, according to interviews and other evidence gathered by the medical examiner:
Benadryl (diphenhydramine): antihistamine
Human growth hormone: (supplement) touted as a muscle-building, weight-reducing agent
Nicorette (nicotine polacrilex): used to quit smoking
Tamiflu (oseltamivir phosphate): anti-viral medicine
Vitamin B12 (nutritional supplement) helps formation of red blood cells
The FDA has concluded that this accidental death likely resulted from the mixing of 13 potent drugs. (The two supplements had unknown effects in combination with the 13 medications.) Ms. Smith's intake clearly exceeded the FDA Recommended Maximum Concurrent Dosage (RMCD) of no more than 12 drugs at a time.
Additionally, the FDA recommends physicians avoid prescribing this same regime of 13 drugs to patients, with the caveat that the elimination of any one drug (thus reducing the regime to 12 medications) could well eliminate any adverse reactions such as death. Which drug should be eliminated from the regime cannot be ascertained without extensive research. The FDA has no plans or budget for such research, and therefore cautions physicians against "testing" 12-drug cocktails haphazardly by prescribing medications without knowledge of patients' concurrent prescriptions from other providers.
Adverse side effects such as seizures, catatonic states, quadrophenia and temporary insanity should be treated with additional medications. In such cases, exceeding the 12-drug Recommended Maximum Concurrent Dosage (RMCD) is allowed on a temporary (6-12 months) basis.
Please note that FDA guidelines recommend elderly or ill patients consume no more than ten (10) drugs concurrently. Since media reports suggest that Ms. Smith was suffering from an infection, her primary physician should have stipulated that no more than ten (10) drugs be administered or taken concurrently.
Please note that the FDA does not test for interactions between drugs, or require such research to be undertaken prior to approval of the medication. The FDA only requires testing the efficacy of a single medication (or "cocktail" of one to three drugs) on a single condition or illness. Thus, the interactions of even two drugs prescribed for differing conditions, much less ten or twelve, have not been clinically studied.
However, given the generic dosing of the elderly (whose drug prescriptions are paid by Medicare) with six or more drugs at a time, regardless of the safety risks inherent in mixing powerful medications, the FDA has been restricted to a toothless recommendation that no more than ten (10) drugs be administered to the elderly (with free Medicare drugs) at a time.
For patients without Medicare or private insurance drug coverage, the FDA recommends a healthy walk in the park and two aspirin a day, as administered by a qualified physician whenever possible, and self-medicated in all other circumstances.
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