Study Cites Risk of Commonly Used Catheter

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— Reuter

(The following article was carried in the Washington Post newspaper (Washington, DC) on December 2, 1995.)

PHILADELPHIA. A widely used intravenous catheter made by a Johnson & Johnson subsidiary may pose a risk of life-threatening reactions in some cases, researchers reported.

A study in the current issue of Annals of Internal Medicine said that two cases of severe adverse reactions were noted in a study of 130 patients receiving treatments through the Landmark brand “midline” catheter.

It said 53 similar reactions, including two deaths, associated with the catheters had been reported to the Food and Drug Administration through June 1994.

“Landmark midline catheters are associated with life-threatening adverse reactions that are probably attributable to the catheter material itself,” the study, conducted by Rhode Island Hospital and the Brown University School of Medicine, concluded.

Johnson & Johnson disputed the study’s conclusions but said it had revised the instructions for the device to clarify the risk of adverse effects and recommend ways to avoid them. A company statement did not specify those measures.

“Investigation by allergists and toxicologists have shown that the rare reports of adverse reactions to the Landmark midline catheter are not likely to be related to the material composition of the product,” the statement from Johnson & Johnson said.

The study said more than 500,000 of the catheters, used to administer antibiotics and other medical therapies intravenously, have been sold to date.

The “midline” catheter is slightly larger than a traditional central-venous catheter. They often are used in home health care and have low rates of infection.

The study said the Landmark catheters were made from a polyurethane and hydrogel compound. It said no adverse reactions were noted with catheters made of Teflon. It said the reactions may have been caused by release of a toxin or allergen from the catheter material.

Followup:

NEW BRUNSWICK, N.J. -(Dow Jones)- Johnson & Johnson, the manufacturer of a popular catheter whose safety was questioned in a recent study, has stopped manufacturing the product, the Associated Press reported late Friday.

J&J said it stopped making the Landmark midline catheter early this week because of sagging sales. The company also stopped making the Streamline and Centermark catheters, company spokesman Bob Andrews said.

“Sales had declined to the point that we couldn’t justify any longer the cost associated with maintaining the business,” Andrews said. “It’s not a withdrawal, it’s not a recall, it’s just a discontinuation of sales on our part.”

J&J wouldn’t divulge sales figures for the product.

A study printed last year in the Philadelphia-based Annals of Internal Medicine said the Landmark midline catheter caused negative reactions when inserted in some patients. The study said government regulators received reports of three heart attacks and two deaths with patients who used the Landmark catheter.

Dr. Leonard Mermel, who wrote the study, said there had been 190 reports of unanticipated problems with the Landmark catheter since 1986. About 726,000 Mainline catheters were used during that time.

Other catheters didn’t have any unanticipated problems, said Mermel, an assistant professor at the Brown University Medical School.

Mermel also found negative reactions in three out of 300 patients with the catheters at Rhode Island Hospital in Providence, R.I. The patients had symptoms including nausea, back pain, chest pain, shaking and skin blotches after the catheter was inserted. The symptoms disappeared within minutes, Mermel said.

J&J defended the safety of the catheter, which had been made by its Menlo Care Inc. unit.

“There are no scientific data, toxicological or otherwise, that document a problem with this product,” Andrews said

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