One of the most prevalent causes of acute liver failure is drug induced liver injury (DILI) and it has emerged as one of the driving forces for the FDA to disapprove new drugs or withdraw existing drugs.

In a post market review by the FDA, they indicated that reports of serious liver injury from Strattera (Atomoxetine) continue to flow into the agency even after a label revision in 2004 warned of hepatotoxicity. Unfortunately, the median age of persons suffering injury is 10.6 years; so it is our children who are most at risk for serious injury or death.

The liver is the primary organ accorded the job of clearing toxic substances from the body. Interestingly, the body typically identifies most all prescription drugs as a foreign/toxic substance. Many substances damage cells in the liver leading to release excessive amounts of enzymes, causing release of excessive amounts of oxidants and leading to hepatic damage.

Drug induced liver injury, including that caused by Strattera (Atomoxetine) can lead to:

    Hepatitis
    Cholestasis
    Steatosis
    Granuloma

The FDA has recommended that physicians speak with patients about:

•    Inform patients to immediately contact their physician at the first sign or symptom of fatigue, loss of appetite, nausea, vomiting, pruritis, dark urine, jaundice of the sclerae or skin, right upper quadrant tenderness, or unexplained “flu–like” symptoms
•    Determine liver enzyme levels when a patient presents with signs or symptoms of liver injury
•    Discontinue and not resume atomoxetine treatment if patients present with jaundice or laboratory evidence of liver injury
•    Report cases of serious liver injury to FDA’s MedWatch program (www.fda.gov/medwatch)

They are called “nutritional supplements”, “health additives” and “body enhancers”. Whatever the name, make no mistake, these are engineered drugs.

The Palm Beach Post had an editorial on Sunday related to an issue that Alyssa Diedwardo has written about a great deal. In fact, Alyssa talked in August of 2008, about the very problem that has led to the suspension of two major league baseball players.

The two unfortunate players, JC Romero and Sergio Mitre each went to a “health store” and purchased entirely legal compounds, right off the shelf: Halodrol and 6-oxo.  Both of these gentlemen tested positive for steroids.

A word of warning to consumers, and a particular word of warning to unwary adolescents, READ the ingredients! This is an industry that, for all intents and purpose, is completely unregulated. Arguably, in fact, it often appears as if the “health” supplement industry is experimenting as it goes along…with the public at large.

I invite you to read more about this industry and some of the problems being seen by visiting our Herbal Supplement website and check out articles written by Alyssa Diedwardo.

Who protects consumers from negligently manufactured or dangerous drugs and medical devices? Is it the FDA? In part, yes and in part, no. The FDA, because of the way in which it was designed to operate, could be said to be analogous to the “fox guarding the hen house”.

In order to fund the operation of the FDA, half its budget comes from fees paid by manufacturers to facilitate a speeding up of the approval process for new drugs and medical devices. In fact, it is understandable that some of the scientists at the FDA see the pharmaceutical and medical device manufacturers as more “their clients”; than they do the consumer. This understandably creates a situation where FDA scientists feel like a part of the drug or device approval “team”, more than a part of the consumer’s police force.

The FDA review process for new drugs and medical devices has been described by some courts as “rigorous”. My experience is that the approval process can be rigorous, but is sometimes not discerning enough on the part of the FDA. Through the Pre-Market Approval process (PMA) manufacturers are supposed to submit detailed information and provide the FDA with “reasonable assurances” that the drug/device is effective and is safe for the consumer. The PMA process provides for differing levels of scrutiny on the part of the FDA. Devices, for example, are broken down into Class I, Class II, and Class II devices. Class I devices are supposed to be those that present the minimal potential for harm to the consumer and are often much more simple in design.  Class II devices are similar to Class I, but are held to a higher level of assurance that they have a lower expectation of causing harm to the consumer; but they are subject to more regulation, often in terms of labeling, performance standards and post market surveillance. Class III devices require the most rigorous clinical and scientific documentation. The Class II review process requires the FDA to evaluate the “probable benefit from the use of the device against any probable risk of injury or illness from such use. 21 USC Sec. 360c (a) (2)(C).”

It is accepted that the FDA may grant approval to drugs and devices that they know may have some level of known complications associated with them, but the benefits of the drug/device make the potential complications acceptable. The problem often lies in product defects the manufacturer knows and fails to disclose to the FDA; or what the manufacturer should have clearly known but did not conduct analysis which was sufficient to discover.

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