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The FDA announced that an unidentified contaminant was found in batches of the active ingredient used in Baxter’s recalled blood thinner Heparin. The FDA still does not know how the substance got into the drug. The drug is being investigated after hundreds of patients reported bad reactions. There have been 19 fatality reports.
On November 5, 2007 the FDA issued a marketing suspension for the anti-bleeding drug Trasylol. Trasylol (aprotinin injection) is approved for use in cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery. The drug has been approved for use since December of 1993. It has been used in surgeries around the world. The FDA is investigating reports that 235 people died in the United States after receiving Trasylol in surgeries from 1993 to February 2006.The marketing suspension was issued after a study was suspended early after test data showed that Trasylol increased the risk of death by 50 percent compared to two other drugs in the same class. The study was performed by researchers in Canada. The study analyzed data from over 3,000 cardiac surgery patients since 2002. The results were so drastic that the study was halted, and no new patients were enrolled pending further analysis. Trasylol has been linked to an increased risk of kidney failure, heart attack and stroke.
The BART studied prompted the removal of Trasylol from countries around the world. The European Union, Great Britain, China and many other counties all joined the United States in the marketing suspension. The FDA has recommended that surgeons weigh carefully the use of existing stock of Trasylol on high risk patients.
More lawsuits have been filed over bacteria-tainted syringes. Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines. In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago. 14 of those patients required hospitalization from five to nine days. All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria,�Serratia marcescens. On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens. The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.
If you have been injured by the Ortho Evra birth control patch, contact our birth control patch lawyers today for a consultation.
The maker of the widely used Ortho Evra birth control patch, Johnson & Johnson, is trying to prevent negative attention over its dangerous contraceptive by purchasing the rights to domain names like Orthoevrakills.com and Deathbypatch.com.
In late 2005 when the Food and Drug Administration urged that a heightened warning alerting users to the risk of potentially fatal blood clot and stroke be added to the drug’s label. In February 2006, a study showed that women using the Ortho Evra birth control patch faced double the risk of blood clots than women who use oral contraceptives. The increased risk is due to the fact that the patch exposes users to higher levels of hormones–60 percent more–than oral medications.
Johnson & Johnson purchased and registered the domain names but is not using them. The move was strictly an attempt to preempt critics of Ortho Evra from attracting negative attention to the dangerous drug.
A federal court jury in Florida has found Johnson and Johnson and its subsidiaries liable in the death of a 21 year old man who was wearing a poweful pain killing patch, Duragesic, when he passed out and died. The jury returned a verdict of $5.5 million in favor of the man’s family, after finding that Johnson and Johnson was negilgent in producing the patch and in failing to provide adequate warnings. This is the second time in a year that a jury has found J&J liable for problems attributable to Duragesic, as last year, a jury in Houston, Texas returned a similiar verdict.