ProHance (gadoteridol) is an injection placed into the vein before an MRI or MRA exam to provide contrast on the test results so the radiologist can easily identify blood vessels. The injection contains gadolinium and is one of five MRI contrast agents which could lead to a serious and potentially fatal disorder for those with impaired renal function. ProHance was approved by the FDA in 1999. It is manufactured by Bracco Diagnostic, Inc., which also makes a newer gadolinium-based contrast which was approved in 2004, MultiHance.
The FDA received more than 5,000 complaints of ProHance side effects between 2004 and 2010. About half of the complaints detailed epidermal and dermal problems in musculoskeletal and connective tissues. Researchers linked these cases to the contrast dye agent. In fact, one of the patients died in August 2007. Additionally, complaints cited dyspnoea or difficulty breathing along with upper respiratory tract congestion, sneezing, throat tightness, and chest discomfort in patients treated with ProHance.
ProHance Brain Deposits
ProHance is a Gadolinium-based contrast agent (GBCA). The Radiology magazine article pushed the FDA to review reports of adverse health effects from ProHance retained in the brain. The agency examined human and animal studies from contrast dye use over periods longer than a year. These publications and reports show the organs such as the brain, bones, and skin retain gadolinium like ProHance. Symptoms of this are bone pain, burning skin pain, chemo brain, skin changes, skin thickening or discoloration.
Then, the FDA ordered “black-box” warnings for all gadolinium-based contrast agents like ProHance. A “black-box” warning is the strongest warning. It is to alert physicians to possible severe kidney damage in at-risk patients. In addition to kidney patients, the warning also extends to patients with chronic liver disease, including those just before or after liver transplantation. The FDA recommends that doctors screen patients for kidney problems prior to receiving a gadolinium-based imaging agent.
Also, the signs of ProHance side effects after an MRI or MRA with contrast could include:
- Thick skin with a woody or shiny appearance
- Tight skin contracting around joints
- Swelling, redness and burning sensations
- Deep pain in the hip or ribs
- General muscle weakness
Free Case Evaluation
A gadolinium lawsuit may be an option for patients suffering from gadolinium retention and related complications. Gadolinium, used in dyes to increase the clarity of MRI and MRA scans, can create chemical element retention in the body, Therefore, this increases the risk of gadolinium deposition disease and nephrogenic systemic fibrosis. These conditions are accompanied by symptoms that include severe physical pain and cognitive difficulties. Affected patients and their loved ones may be able to file a lawsuit and recover damages.
Therefore, for more information, contact The Michael Brady Lynch Firm. We offer free, confidential, no-obligation consultations. We have over 20 years experience helping consumers injured by unsafe products manufactured by large companies.