Duract Drug: Issues on safety

In the instances that people fall ill or just need a quick patch up for some pain, the first thought that enters one’s mind is to grab some medicine from the medicine cabinet. Usually, the effect would be the alleviation of the symptoms of the ailment or at least bring the pain to a more tolerable level. That is the presumptive, standard scenario in taking medicine. But what if the reverse happened; instead of relief, more serious health issues arise? Duract Drug: History

First seen in the market in 1997 (Defective Drugs FYI), Wyeth Ayerst Laboratories applied for the approval for the sale of Duract Drug in 1994 (Defective). Classified as a “non-steroidal anti-inflammatory drug (NSAID)”, the drug was authorized for sale in July 1997 (Defective). In a short span from its inception into the market, a flood of prescriptions were filled out for the drug, reaching about 2. 5 million in that short span (Drug Recalls). Duract was originally meant to be prescribed as a short term regulation of pain, or for 10 days or less (Defective).

The sound of recall After its approval in 1997, FDA officials warned of the drug’s severe effects on a patient’s liver (David Willman). After receiving reports the drug had caused severe liver damage that resulted at times to liver failure (Finkelstein & Partners). How exactly did the drug damage the liver of a person? One, the drug was found to increase levels of enzymes in the liver (Finkelstein). Ayerst declared that the drug should be used only in the short term, and not for long term use (Finkelstein).

Officials in the FDA allied themselves with the manufacturer, saying that the threat of liver illnesses was addressed in the label of the drug (Willman). In the course of treatment, the liver, responsible for the elimination of toxins in our blood, it is susceptible to contamination and damage from the intake of drugs (Michelle Meadows). In many of the cases that were reported to the FDA, many of them testified that the drug was taken longer than the prescribed period for the drug (Finkelstein).

As a result of this finding, the FDA put in a “black-box” warning attached to the label of the drug, with very little or negative impact (Finkelstein). Drug Safety Did the drug manufacturer basically produce a drug that was not safe? What is safe in the first place? According to the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), the term “safe” means that a medication or drug will afford the person more benefits if they take the medication (Meadows).

The intake of the drug and its effects will outstrip the risks that the intake of the drug will manifest (Meadows). It is given therefore, according to the CDER definition; there are drugs that are safe yet without risks in its use, or harmless drugs (Meadows). In the example of drugs for the treatment of cancer, there is no question that these drugs are quite toxic, but the benefits of these drugs to the patient would outweigh the risks involved (Meadows).

When the addition of the black box warning was instituted by Wyeth Ayerst, additional instances of liver failure cases and liver transplants were chronicled by the FDA and the company (Finkelstein). This resulted in the recall of the drug from the market 10 days after (Finkelstein). Only after eleven months in the market, Duract was cited to be involved in the deaths of about 68 people (Willman). Among the fatalities were 17 who died of liver failure (Finkelstein). In the ensuing fall-out from the recall, it was learned that the company gained about $ 89 million during the one-year run of the product (Recall).

A court in Texas approved a “class-action” case against the company for damages by people who have not displayed the symptoms but have been taking the drug in March 2001 (Recall). The FDA has been at the forefront coordinating with organizations to ascertain liver illnesses before the prescription of medications (Meadows). At present, the FDA is conducting seminars and workshops designed to better evaluate the diagnosis and treatment of liver illnesses (Meadows). Works Cited Defective Drugs FYI. “Duract”.

<http://www. defectivedrugsfyi. com/duract. html> Drug Recalls. “Duract”. <http://www. drugrecalls. biz/duract. php> Finkelstein & Partners. “Dangerous drugs”. <http://www. lawampm. com/flgp/home. nsf/drugs> Meadows, Michelle. “Serious liver injury: leading reasons for drug removals, restrictions”. FDA Consumer Magazine May-June 2001. Meadows, Michelle. “Why drugs get pulled off the market”. FDA Consumer Magazine January-February 2002. Willman, David. “How a new policy led to seven deadly drugs” Los Angeles Times A1

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