Archive for the 'Medication' Category

Generic drug maker cited for defective drugs

Monday, July 6th, 2009

The Food and Drug Administration has seized several plants belonging to the drug manufacturer Caraco Pharmaceutical Laboratories Ltd. for manufacturing violations.

The FDA cited multiple violations of manufacturing standards and seized approximately 33 different generic drugs at three different plants. The FDA will prevent Caraco from distributing anything until they have assurance that the company will comply with FDA standards in the future.

The drugs that were seized were generic forms of heart, pain, and psychiatric medicines. Caraco was accused of poor handling of drug ingredients and varying tablet-manufacturing processes.

People currently taking drugs made by Caraco should not be concerned and should continue to take their medications as prescribed. Any defective drugs should have been weeded out of the market already by recalls.

The seizure of these drugs could cause a shortage of choline magnesium trisalicylate oral tablets. If you are currently taking this medication and experience a supply shortage in your area, talk to your doctor about an alternative drug.

Contaminated heparin tied to deaths

Monday, August 4th, 2008

According to a July 30 story published in the Chicago Tribune, the U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients to specific lots of contaminated heparin made by Baxter International Inc.

In an interview, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animal-like substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those seven patients received heparin contaminated with the substance.

“We have what looks like a cause and effect in some patients,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. “We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain.”

Baxter recalled its heparin products in February in the wake of the spike in the number of the allergic reactions. In recent months, federal health officials and Baxter believe the oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China

Several wrongful death lawsuits have already been filed against Baxter and other manufacturers who allowed contaminated heparin onto the market.

Digitek Dangers

Friday, August 1st, 2008

On April 25, 2008 Digitek (digoxin), a medication used to treat congestive heart failure, abnormal heart rhythms, and other conditions, was recalled due to the possibility that tablets were doubled in thickness and could contain twice the approved level of the active ingredient. The existence of double-strength pills pose a risk of digitalis toxicity, which can result in nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death.

 

If you or a loved one has been harmed by Digitek, or any other dangerous drug or product, contact the Digitek attorneys at Cappolino Dodd Krebs LLP today, at 1-800-460-0606 for a free evaluation of your legal rights.