The Wall Street Journal-20080128-In Brief
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In Brief
Full Text (323 words)Johnson & Johnson Unit
Recalls Balloon Catheters
Johnson & Johnson's Cordis subsidiary issued a world-wide recall for about 132,000 balloon catheters used to expand blood vessels after it was determined problems with the devices could cause injury or death. There have been no reported deaths associated with the "Dura Star RX" and "Fire Star RX PTCA" balloon catheters, according to a Cordis spokesman. The recall affected about 57,000 devices in the U.S., but isn't a material financial issue for the company. J&J said the recall doesn't affect Cordis's Cypher drug-coated cardiac stent, as the stent isn't delivered on these balloons.
Baxter Recalls Heparin
Over Allergic Reactions
Baxter International Inc. issued a nationwide recall of thousands of doses of heparin because of scores of allergic reactions and one death possibly linked to the prescription injectable anticoagulant. The heparin that was recalled is used primarily in heart surgery and dialysis, Baxter officials said, and patients in hospitals nationwide may be affected. It said it can't yet determine how many doses have been administered. The Deerfield, Ill., company began recalling the lots Jan. 17. Baxter said it normally receives 60 to 70 reports a year of possible reactions to heparin, but it has received about 150 such reports already this year.
Merck Can't Sell
Mevacor Over the Counter
The Food and Drug Administration rejected a bid by Merck & Co. to sell its cholesterol-lowering drug Mevacor without a prescription, the company said Friday. The Whitehouse Station, N.J., pharmaceutical maker said the FDA issued a "not approvable" letter for allowing a 20- milligram dose to be sold over the counter. The decision was expected. Merck said the FDA indicated it would require a revised label and additional data from the company in order to gain marketing approval. "We're evaluating the conditions outlined in the agency's response to determine a path forward for Mevacor OTC," said Edwin L. Hemwall, Merck's vice president, global OTC regulatory and scientific affairs.
