Posts Tagged ‘dangerous drugs’

The FDA has been experimenting with new computer technology as part of a broader effort to test the safety and effectiveness of new drugs and to spot potential problems earlier on in the process.  The technology, called the Cardiovascular PhysioLab, designed by Entelos Inc. of Foster City, California, is being used with three drugs being studied for heart-related conditions.  The technology uses a mathematical model to simulate how the human body will react to certain chemical characteristics of drugs.  The goal, thus, is to use the virtual model to predict whether such drugs might cause cardiovascular problems and, if so, in what types of patients. 

While such novel efforts certainly show that the FDA is making a strong effort to research and consider the most groundbreaking technologies to ensure the safety of new drugs, it is likely that people will remain skeptic of what appears to be a computer program acting as a substitute for real patients until it has shown consistent, reliable results.  Simply punching in the characteristics of a given patient and a particular drug to obtain a computer-generated result cannot guarantee the absolute same result in a living, breathing person.  However, this could be a step forward at least in assisting the process and anticipating whether a drug could be dangerous for certain people before such adverse effects may occur.  Read more about dangerous drugs and possible side effects.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.