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FDA 678 articles

Ortho Evra lawsuit settled for $1.25m as J&J tries to avoid public trials

Ortho Evra manufacturer, Johnson & Johnson, recently settled a lawsuit with the family of a 14-year-old girl killed by the defective birth control patch. The case is just one of many Ortho Evra lawsuits settled by Johnson & Johnson prior to going trial. It likely hints at the company’s desire to avoid trials where its actions -or lack thereof – regarding safety problems with the defective Ortho Evra birth control patch could be called into question. When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The ... Read More

Gadolinium MRI contrast agents linked to Nephrogenic Systemic Fibrosis

Gadolinium based MRI contrast agents and Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD) have been linked in yet another study. This time, researchers in Scotland have confirmed that gadolinium based contrast agents used in MRI’s are strongly associated with the onset of this often fatal disorder in people suffering from pre-existing kidney disease. Their findings only add to the growing body of evidence that shows a strong connection between NSF/NFD and gadolinium based contrast agents that are often used in MRIs. The Scottish gadolinium MRI contrast agent study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow ... Read More

MRI contrast agents get strong kidney-risk warning

Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning. The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents. The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to ... Read More

MRI Gadolinium contrast agents get black box warning

The U.S. FDA indicated that it would start adding its strongest ‘black box’ warnings to gadolinium based contrast agents used in MRIs by May of next year. There are five different types of gadolinium based contrast agents, and the FDA has evidence enough to suggest a causal connection between the agents and a skin condition called nephrogenic systemic fibrosis (NSF) in patients with impaired kidney function. NSF normally begins from days to several months after the exposure to the contrast agents, and results in the thickening and tightening of the skin. Skin may become spotted and may be accompanied by ... Read More

Drug industry seeks tests to spot side effect risks

Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs. The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome. “SAEC’s focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event,” Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday. The findings of the consortium ... Read More

Gadolinium based contrast agents more common and deadly than previously thought

Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD), a painful conditions that has been linked to the use of gadolinium based contrast agents used in Magnetic Resonance Imaging (MRI), could be more prevalent than once thought. A recently released study also found that kidney patients with NSF/NSD are far more likely to die than those without the disorder. NSF/NFD, a disease that affects people with pre-existing kidney disease, leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or ... Read More

Kugel Mesh patients not out of the woods yet

Rockville, MD: Just because the Kugel Mesh Patch was recalled over a year ago does not mean that adverse event reports regarding the hernia patch are no longer being submitted to the U.S. Food and Drug Administration (FDA). In fact, the FDA received numerous reports in August of serious problems with the Kugel Mesh Patch, some of them life-threatening incidents. The reason that people are still suffering serious complications from the hernia patch is that when the recall was announced, doctors were told to weigh the risks of leaving the patch in with the risks of explanting it. Patients who ... Read More

Osteoporosis drugs to undergo FDA safety review

The Food and Drug Administration (FDA) is going to be taking another look at Fosamax and other bone building drugs because they could be causing irregular heartbeats in some patients. The FDA safety review of bisphosphonates, a class of drugs often used to increase bone mass in order to treat osteoporosis, was prompted after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation. Bisphosphonates are used to increase bone mass and reduce fracture risk in patients with osteoporosis. They also are also used to slow ... Read More

FDA study said to show Avandia risk

The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday. In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration “several months ago” recommended a “black box” on the drug’s label, the strongest possible warning.It is the first confirmation that the FDA’s ... Read More

MedWatch 2007 Avandia

Avandia (rosiglitazone) Audience: Endocrinologists, other healthcare professionals, consumers Posted 05/21/2007 FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue ... Read More