Articles Posted in Defective Drugs

The U.S. Department of Justice has sued drug manufacturer Actavis, seeking a permanent injunction against its subsidiary that makes the recalled heart drug Digitek. According to this Bloomberg News report U.S. regulators took the action on behalf of the Food and Drug Administration against the Actavis Totowa LLS subsidiary in Little Falls, New Jersey.

In April the Iceland-based drug manufacturer recalled all of its lots of prescription heart drug, Digitek or Digoxin tablets, because some of the tablets might contain twice the approved level of the active ingredient. Hundreds have reported suffering serious injuries. Families have reported losing loved ones to this defective drug, which was normally prescribed to treat heart failure and abnormal heart rhythms. Actavis makes the drug for Mylan Inc., which distributes the drug under its Bertek and UDL brands. Actavis has said it has been working to meet the FDA’s manufacturing standards for its New Jersey facility.
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Last week, pharmaceutical company Actavis Totowa LLC recalled all lots of its prescription heart drug, Digitek, because some of the drug’s tablets might contain twice the approved level of the active ingredient. According to an article in The Chicago Tribune, people have become sick or injured after taking the drug, which is used to treat heart failure and abnormal heart rhythms.

The defective Digitek tablets were manufactured with double the appropriate thickness, which means it may contain twice the approved level of active ingredients. Toxicity from this drug, because of the high dosage, may cause nausea, vomiting, dizziness, high blood pressure, cardiac instability or even death.

This apparently dangerous drug dosage was reportedly distributed by Myland Pharmaceuticals Inc. under a “Bertek” label and by UDL Laboratories Inc. under a “UDL” label.

It would be helpful to the Food and Drug Administration’s efforts for you to report any reactions to this drug to the FDA’s MedWatch adverse reporting program at www.fda.gov/medwatch/report.htm. Of course, contact the doctor that prescribed Digitek to you for his/her advise at your earliest opportunity.
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The big news this morning is that pharmaceutical giant Merck is handing out Vioxx claimants what could well be the biggest payout in the history of civil cases. Company officials today approved a $4.85 billion settlement to make payments out to almost 50,000 claims filed against the company involving the drug Vioxx, which many claim had disastrous side effects such as strokes and heart attacks.

The deal will take effect only if 85 percent of all plaintiffs agree to drop their cases, according to an Associated Press news report this morning. Eventually, Merck pulled the defective drug off the shelves, but many say that was too little too late. The damage had already been done. The giant settlement means that Merck will just pay out the money without admitting any fault or that it manufactured, marketed or sold a defective drug.

The deal has reportedly been in the works for several days now, according to the AP report. Those who have been following the trial will no doubt be surprised by this sudden announcement. So far, Merck has successfully defended many of these Vioxx cases. But company officials made the decision because their legal bills would run into billions over the many years this process takes to complete itself.
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MRI scans are as common as x-rays these days. But here is a news report that will make you think twice before you enter the belly of that scanner. On Wednesday the Food and Drug Administration issued a statement asking manufacturers of certain contrast agents, used in patients who get MRI scans, to place a black-box warning on the agents so patients are aware of the risks involved. Apparently these agents can be lethal to patients who have severe kidney problems, according to an article posted on CNN.

According to this article, the warning would involve five gadolinium-based contrast agents, some of which are manufactured by General Electric Co.’s health care unit as well as BAY, an arm of Bayer and Tyco. FDA officials say these agents, when used on someone with severe kidney problems, “could cause a debilitating and potentially fatal disease called nephrogenic systemic fibrosis.” Among others who are at risk are patients who are undergoing a liver transplant or those with chronic liver disease.

FDA officials say this condition, commonly referred to as NSF, can cause thickening of the skin and connective tissues and restricts their mobility resulting in broken bones. This type of fibrosis may also develop in the diaphragm, thigh and lower abdominal and lung vessels. NSF is a debilitating condition that results in gradual deterioration and may eventually lead to death. The agents in question are used to enhance visibility of internal organs when patients undergo an MRI. According to FDA officials, the contrast agents are not required for an MRI to be done.
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A Dallas pharmacy company erroneously made a drug 10 times more potent than intended, killing three people who received it at an Oregon clinic, according to the state medical examiner’s report. ApotheCure Inc., a drug compounding pharmacy company, said an employee committed a weighing error in making the drug colchicine, according to an Associated Press news report posted in The Dallas Morning News Website. The drug was sent only to the Center for Integrative Medicine in Portland, where three people received injections of the defective batch to treat back pain, company officials said.

All three recipients of the defective drug — two from Portland and one from Yakima, Wash. — died between the end of March and beginning of April from the toxic levels of the drug, officials said. The Food and Drug Administration said it is investigating the deaths, but the agency’s officials believe that the problem has been contained, according to the article.

The article reported that Gary Osborn, a pharmacist and certified clinical nutritionist for ApotheCure Inc., said the problem could have been contained even earlier had the clinic contacted ApotheCure Inc. after the first death occurred. Osborn told the Associated Press that the clinic did not contact then until nearly two weeks after the first death. He also said the second death occurred before the company was able to completely recall the bad batch and send a new lot.

Osborn said this is the first such incident in his company, which he says is an industry leader.

“But you know what people say, stuff happens,” he said to the reporter.
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