Fifty years ago, it wasn’t unusual to find products sold in the drug store with a “Skull and Crossed Bones” on the label. Tincture of Iodine was one product that most seniors are familiar. Black Box drugs are now long gone, replaced with branded products that cost much more. Today’s prescription drugs carry such warnings not on the label but on the Physicians Package Insert, a “Warning” boxed by a black border. This is supposed to alert the physician to the fact that improper use can result in death.
Unfortunately, the physician seldom sees the Physician Package Insert because it is produced and packaged with the medicine that is shipped to the pharmacy. The Physician has to rely on the Physicians Desk Reference Book (PDR) in his office. The Physician Package Insert is normally trashed with the empty bottle that the medicine came in at the pharmacy. Seldom is it used unless the patient or physician asks for it.
The patient usually gets a good abbreviated version of the package insert that focuses on the proper way of using the medication and a warning of what symptoms may arise if there is a reaction to the medication.
The fact is that Black Box drugs are never mentioned.
Three decades ago, when my youngest daughter was about six years old she came down with a bacterial infection. The physician prescribed a new form of Erythromycin with a prolonged high blood level profile. This meant that the level of Erythromycin in the blood remained high over an extended period compared to the other brands being detailed to the physician.
This was truly a marketing advantage for the manufacturer. This medical miracle was accomplished by adding a soap molecule to the erythromycin molecule to slow down the liver’s ability to biodegrade it and excrete it.
My daughter got a blotchy skin rash upon taking it that disappeared as soon as we hastily took her off the medication. It soon was known that many people were having adverse reactions to this drug.
Public Citizen petitioned the FDA in 1973 and again in 1979 requesting that the drug be taken off the market. Their petitions on behalf of the citizens of the United States were denied. Instead, the FDA and manufacturer agreed that a “Black Box” warning be added to the Physician Package Insert.
You normally find a Black Box Narrative on the obituary page highlighting someone’s death. The action taken by the FDA was face-saving for the FDA, since they did not have to admit they made a mistake by approving the drug in the first place, and it allowed the manufacturer to continue to market the drug at a profit for the next 30 years.
The FDA can only remove a prescription drug from the market with the consent of the manufacturer unless the FDA is willing to take legal action and submit evidence to the court that the drug is harmful. I do not recall an instance where this has been done.
The FDA would not take this action since it focuses attention on the fact that the FDA has made a mistake in the first place by approving the drug and the process is time-consuming and costly. The compromise position is to put a “Black Box” warning on the package insert and not on the label of the drug where it would be a warning to all who see the label.
It has taken the medical profession almost 30 years to learn about the higher side effect profile of erythromycin estolate manufactured under the brand name Ilosone by Eli Lilly and stop prescribing it. The various Ilosone products have been quietly discontinued over the last few years by Lilly because of falling profits and declining sales.
In 2002, the FDA published a research article demonstrating that Ilosone alone stood out with a side effect profile 12 times greater than the other chemical forms of Erythromycin.
Too little too late.
The above “Black Box” episode has been repeated time and again over the last 40 years with other prescription drugs. In 2002, an article appeared in the Journal of the American Medical Association analyzing the facts that from 1975 to 1999, 45 drugs had a black box warning added after the drug was approved.
Out of the 45 drugs, the manufacturer withdrew 16, but 29 remained on the market. According to another article, there are about 375 drugs with black boxes on the market and 25 percent have a high potential for adverse reactions.
There are too many black box drugs being prescribed today that have alternative drugs that do not have the potential to be deadly.
There are some that have an established use under close medical supervision. The main category is anti-neoplastic drugs (cancer drugs) plus various drugs used in high-risk life-saving situations. All of which require close medical supervision.
Others fall into the same category as Ilosone where there are many safe alternatives.
The FDA does not publish a list of “Black Box” drugs, nor can you get a copy of the actual Physician Package Insert from the FDA, but if you know how to negotiate their website (http://www.fda.gov/cder) then ([email protected]), you can find out all the information that you need to know about the drug.
Your other sources are to ask the pharmacist, go to the library and find the reference copy of the PDR or contact the manufacturer who may or may not provide you with a copy.
Also, Adverse Drug Reaction reports sent to the FDA are not assembled and readily available to the public. In the mid-nineties, the FDA stopped publishing a ranking of ADR reports by drug and their frequency. An OTC drug named Aleve won a top spot in the first year of retail sales to the consumer. Since then, it is anyone’s guess as to the number of ADR’s reported for this OTC drug. The FDA has outsourced the process of assembling information about ADR’s of Rx and OTC drugs and it has become a private business affair.
The FDA appears to be protecting the manufacturer from harm rather than the American Public – the recipients of deadly drugs all too often.
Go to Public Citizen at http://www.worstpills.org to learn more about what is causing two million plus hospitalizations and about 100,000 deaths a year from ADR’s. These events have to be a major cause of medical malpractice lawsuits.
Can anyone explain why the FDA is claiming that the prescriptions from Canada are so unsafe when they have a more serious problem right here in the US in monitoring dangerous drugs that are on the US market and approved by the FDA?
God Bless America and all our citizens. We need all the help we can get to survive the bureaucracy in Washington that has lost sight of why they exist in the first place.
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