Side Effects & Recall Lawsuit
ProHance Side Effects Lawsuit
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ProHance Side Effects Lawsuit
ProHance Side Effects Lawsuit
ProHance, brand name of Gadoteridol, is a popular gadolinium-based contrast agent manufactured by pharmaceuticals major Bracco Diagnostic. The contrast drug helps in improved MRI of the central nervous system. ProHance also helps radiologists easily distinguish leaky blood vessels and problematic tissues in patients during MRI scans. However, the side effects of the drug can lead to rare disorders, such as Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy, in people with impaired renal function. It has also been linked to liver problems, cardiovascular side effects, skin diseases, and other potentially life-threatening conditions.
ProHance and FDA Warnings
The FDA approved ProHance in 1999 for clinical use. Following numerous reports of epidermal and dermal side effects, the FDA issued a public health advisory in June 2006, informing health professionals about possible fatal skin disorders caused by the drug. A study by the Danish Health Authority in 2007 highlighted 25 Nephrogenic Systemic Fibrosis cases, where patients with impaired kidney and liver functions developed the rare disorder after taking gadolinium-based contrast injections during diagnostic tests.
The findings of the Danish report prompted the FDA to
display black box warnings on all gadolinium-based imaging drugs, including ProHance. The new label changes warned doctors and patients suffering from kidney and liver ailments about potential fatal side effects of the drug. A review by the FDA in 2009 named all the five gadolinium-based dyes in the market as potential life-threatening drugs in specific conditions. The FDA updated its warning in December 2010 and called for close monitoring of kidney patients who had been administered ProHance for NFS disorder.
ProHance Complaints
The FDA received more than 5,000 complaints of ProHance side effects between 2004 and 2010. About half of the complaints were related to epidermal and dermal conditions and consequent problems in musculoskeletal and connective tissues. There were more than a dozen cases throughout the United States, Japan, and Europe during the same period, when patients aged between 25 and 75 years had to be hospitalized due to anaphylactoid reaction following ProHance administration. One of the U.S. patients died in August 2007.
There were also complaints of dyspnoea by patients from the United States, Asia, and Europe following ProHance administration. The FDA received about 200 reports of difficult respiration, upper respiratory tract congestion, sneezing, throat tightness, and chest discomfort in patients treated with ProHance.
Major ProHance Side Effects
Nephrogenic Systemic Fibrosis:
ProHance has been linked to rare but fatal disorders. The drug releases gadolinium directly into the blood and residues continue to remain in patients with chronic renal insufficiency or hepato-renal syndrome. The presence of gadolinium in the body causes fatal Nephrogenic Systemic Fibrosis diseases. This disorder involves formation of excessive fibrous connective tissues in the body, which results in skin stiffness, burning sensation, and swelling in lower extremities. It also creates a number of dermal and epidermal problems. This progressive disorder leads to fibrosis and hardening of joints, eyes, and muscles creating limitations on mobility. It can cause damage to internal organs and even death of patients. No viable medical treatment is available for this disorder.
Cardiovascular Side Effects:
According to the post-marketing records, ProHance causes a number of cardiovascular problems in patients. There have been numerous reports of hypertension, nonspecific ECG changes, and tachycardia in patients who had taken ProHance during their diagnostic analysis. There have also been a few reports of arrhythmia and deep venous thrombophlebitis caused by the drug. According to the FDA staff review, ProHance side effects can cause severe compartment cardiovascular syndrome, which can only be overcome by surgery.
Gastrointestinal Problems:
ProHance has been linked to acute gastrointestinal side effects. It causes itching tongue, dry mouth, abdominal cramps, stomach pain, gingivitis, and increased salivation in healthy patients. More serious side effects include dysphagia, chronic gastrointestinal distress, constipation, and anorexia.
Nervous Disorders:
Between 2005 and 2010, the FDA received more than 500 reports on nervous system disorders as a result of administration of ProHance injections. The short-term nervous system side effects of the drug include dizziness, tremor, and loss of consciousness. Anxiety and mood disorders are the most common long-term side effects. Patients have experienced mental status decline, migraine, paresthesia, seizure, loss of coordination in arm, and convulsions after multiple use of the drug during MRI tests.
Ocular Side Effects:
ProHance leads to ocular side effects, including visual field defect, temporary double vision, and lacrimation disorder. Formation of excessive fibrous tissues around the eye caused by NFS disorder can lead to permanent loss of vision.
Dermatologic Problems:
All gadolinium-based contrast agents have dermal and epidermal side effects. A patient experiences intense itching sensation, sweating, and hives soon after taking the drug. Important dermatologic side effects of the drug include urticaria, facial edema, pruritus, allergies, and discoloration of the skin caused by paucity of oxygen in the cells.
Musculoskeletal Side Effects:
Musculoskeletal side effects constitute the second highest number of ProHance complaints made to the FDA. Most of the patients have experienced pain in the back, hip, ribs, and joints. Development of Nephrogenic Systemic Fibrosis creates general muscle weakness and limits mobility of patients.
Other Gadolinium-Based Contrast Agent Lawsuits
Hundreds of lawsuits have been filed against the manufacturers of gadolinium-based contrast agents. Bayer and GE Healthcare paid about $100 million to settle 150 NSF cases involving Magnevist and Omniscan until 2010. There are still more than 500 NSF lawsuits are pending in various U.S. courts involving Bayer, GE, Bracco Diagnostics, and Mallinckrodt. The plaintiffs are expected to earn close to $100,000 in settlements from the drug manufacturers.