A CNN report says
Drug recalls surge
Drug recalls hit a new record in 2009, with one company accounting for more than 1,000 of them.
Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.
The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.
One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.
“We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” said Bowman Cox, managing editor of the Gold Sheet. “That’s a meaningful development.”
The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. “If we continue at this same rate, we could get 600 or more recalls by the end of the year,” he said. “That’s still a very high rate of recalls.”
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
21 Children’s Tylenol Products Recalled
The makers of Tylenol are recalling 21 children’s and infant’s Tylenol liquid products manufactured between April 2008 and June 2008 from warehouses and retail stores as a safeguard against potential contamination.
In consultation with the U.S. Food and Drug Administration, McNeil, a subsidiary of Johnson and Johnson (JNJ, Fortune 500), decided to “recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria” as a precaution, adding that “the likelihood of a serious medical event is remote.”
According to McNeil’s statement, scientific literature about the bacteria suggests that ingesting a contaminated pharmaceutical product orally doesn’t trigger an infection, but use of products such as a nasal spray with the bacteria has lead to infections.
Spirit of Prophecy comments:
“There are many ways of practicing the healing art; but there is only one way that Heaven approves. God’s remedies are the simple agencies of nature, that will not tax or debilitate the system through their powerful properties. Pure air and water, cleanliness, a proper diet, purity of life, and a firm trust in God, are remedies for the want of which thousands are dying…. Fresh air, exercise, pure water, and clean sweet premises, are within the reach of all with but little expense; but drugs are expensive, both in the outlay of means, and the effect produced upon the system.”—“Testimonies for the Church,” Vol. V, p. 443.
Quite remarkable was the report by John Hopkins’ Dr. Barbara Starfield in the July 26, 2000 issue of JAMA. This report (“Is US Health Really the Best in the World?”) expressed concern that U.S. health falls way behind other industrialized nations. It summarized death rates from several causes in the following way:
Thus we have a modern, medical authority telling us that, despite today’s much rarer use of mercury, strychnine, and arsenic in medicines, we still have at least 113,000 (106,000 + 7,000) deaths a year due to medicinal drugs, with 93.8% of that number involving no errors whatsoever. In other words, nearly 1 out of every 20 people who die in the United States each year die as a result of a medicinal drug they receive.
Why the Numbers Could Be Higher
When we examine the study that Dr. Starfield based her 106,000 figure on, we discover that the picture may be better or worse than that. According to Lazarou et. al. in “Incidence of Adverse Drug Reactions in Hospitalized Patients,” deaths in hospitals due to properly prescribed and properly administered drugs range from 76,000 to 137,000 (JAMA, Apr. 15, 1998). 106,000 was but the average of these two numbers.
Lazarou’s study only considered serious Adverse Drug Reactions (ADRs) in its calculations, and excluded events considered to be possible ADRs. It also excluded events “caused by errors in administration, noncompliance, overdose, drug abuse, or therapeutic failures.”
The study defined a serious ADR as “an ADR that requires hospitalization, prolongs hospitalization, is permanently disabling, or results in death.” One can imagine that a serious ADR that was permanently disabling rather than fatal this year could be a contributing factor toward death in later years.