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Bayer’s Magnevist was the first intravenous contrast drug to be approved for clinical use in the United States in 1988. The drug helps make diagnostic tests, such as MRI scans, easier to read. It is administered to patients before they take diagnostic tests to ensure a clear view of leaky blood vessels, organs, and various non-bony tissues in the body. However, patients taking the drug have suffered from several disabling and potentially life-threatening conditions, including liver problems, fatal skin diseases, and Nephrogenic Systemic Fibrosis (NSF) – a rare kidney disease.
In June 2006, the FDA first alerted medical practitioners about fatal Magnevist side effects following the identification of 25 Nephrogenic Systemic Fibrosis cases by the Danish Health Authority. A public health advisory by the federal regulator warned about the risk of fatal skin diseases and NFS disorder in kidney and liver patients using gadolinium-based imaging agents, including Magnevist. The drug triggers thickening of the skin, tissues, and organs, causing difficulty in movement and broken bones. In May 2007, the FDA asked the drug manufacturer to add mandatory "Black Box" labels on the drug, alerting patients with kidney and liver problems about possible side effects.
In November 2009, a staff review by the FDA named Bayer AG's Magnevist among the drugs leading to the highest risk of skin disease. The regulator called for a meeting of a panel of outside experts in December to discuss the NFS complaints. In September 2010, the FDA banned the use of Magnevist and two other drugs during the diagnostic tests of patients with acute or chronic kidney problems following the expert panel recommendations and research reports on the side effects of the drug. The new label on the drug required the patients to be screened for kidney dysfunction before taking the drug. According to a research report in the June 2011 issue of the medical journal Radiology, there have been no complaints of the NFS disorder after the FDA limited the use of Magnevist and gadolinium-based contrast drugs during diagnostic tests.
NFS is the most serious side effect of Magnevist. It is a painful disorder caused by the formation of excessive fibrous connective tissue, which leads to scaling, tightening, and hardening of the skin and other tissues. The disorder gradually spreads to joints, eyes, and internal organs and damages them. Its symptoms include skin stiffness, swelling of the lower extremities, burning sensation, redness, and dark patches on the skin. There is no medical cure for this disorder, and it can be fatal if it involves all the body organs.
Magnevist can cause death related to myocardial infarction. There have been reports of hypertension, arrhythmia, tachycardia, nonspecific ECG changes, and deep venous thrombophlebitis in patients who had taken the drug for better diagnostic analysis. A few complaints to the FDA on Magnevist side effects include compartment cardiovascular syndrome requiring surgery.
According to post-marketing reports, Magnevist causes gastrointestinal distress, stomach and abdominal pain, increase in salivation, constipation, anorexia, and dry mouth in healthy patients.
Magnevist injections lead to short-term dizziness and headache. However, a few patients have suffered from long-term nervous system problems, such as anxiety, migraine, paresthesia, and convulsions.
NFS caused by the drug could impact the tissues in the eye. Double vision, visual field defect, eye pain, and lacrimation disorder are other known side effects of Magnevist.
Skin stiffness, intense itching sensation, urticaria, local dissolution of dead tissues and facial edema are documented Magnevist side effects.
Magnevist users often experience deep pain in the hip or ribs and general muscle weakness. The NFS disorder induced by Magnevist leads to severe restrictions on movement.
The FDA review of post-marketing reports has identified numerous patients with chronic renal insufficiency that had to undergo hemodialysis following administration of the drug during MRI and other diagnostic tests. Research reports have warned of hepato-renal syndrome as a possible side effect of Magnevist.
Chest pain and tightness, fever, weakness, injection site problems, cold-like side effects, sore throat, localized edema, and pelvis pain are other side effects of Magnevist.
Hundreds of lawsuits have been filed in the United States against Bayer and the makers of four other gadolinium-based contrast agents. In its 2009 annual corporate report, Bayer admitted that it was served a notice in 310 Magnevist lawsuits. In May 2007, a woman from Ohio filed a lawsuit against Bayer claiming that its contrast drug Magnevist was responsible for the death of her 24-year-old son Trevor Drake. The deceased, who died in 2004, had undergone MRI scan for end-stage kidney disease.
In July 2008, a Minnesota woman sued Magnevist manufacturer Bayer for selling defective drugs and failing to warn patients about NSF side effect. The plaintiff had received Magnevist injection on March 23, 2001 during her MRI scan and was diagnosed with the NSF disorder six years later. The lawsuit also claimed that chemical make-up of the drug helps gadolinium become free within the body and cause severe health problems in patients with renal insufficiency.
In March 2009, Northern District of Ohio federal court Judge Dan Polster confirmed initiation of settlement talks by Magnevist manufacturer with plaintiffs. A month later, Bayer publicly acknowledged that the company had reached a settlement with 140 litigants over the NFS side effect claims.
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