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Pharmaceutical 7071 articles

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

Wyeth must pay $134.1 million in menopause drug lawsuit

Wyeth must pay $134.1 million, including $99 million in punitive damages, over its mishandling of menopause drugs that helped cause three Nevada women’s cancers, a jury ruled. The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs. “We got the word out that a lot of women have been injured by this type of ... 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

Jury awards 3 women $134.5 million in hormone therapy lawsuit

Reno, Nev., (AP) – A jury has levied a $134.5 million judgment against the pharmaceutical maker Wyeth in a lawsuit filed by three Nevada women who contended that the company’s hormone-replacement drugs had caused their breast cancer. It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts. The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington. A Wyeth spokesman, Douglas ... 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

New kidney disease can be fatal

Kidney disease patients with a newly identified disease called nephrogenic systemic fibrosis (NSF) are at increased risk of death, U.S. researchers report. The researchers also concluded that exposure to gadolinium, a contrast agent used in MRI scans, is a significant risk factor for developing NSF, a painful and debilitating condition characterized by a thickening and hardening of the skin. It usually affects the arms and legs but can also affect internal organs. The disease can progress so rapidly that some patients are immobilized and confined to a wheelchair within weeks. The study, led by Jonathan Kay of Massachusetts General Hospital ... Read More

Avandia on the risk of heart attack and death from cardiovascular causes

Background Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined. Methods We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the ... 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

Parents sue Paxil maker for heart defects

Five more suits have been filed in Pennsylvania against the makers of the antidepressant Paxil on behalf of children who have developed severe heart problems. Three of the families sued for wrongful death and two for personal injury. The families contend that the mothers’ use of Paxil during pregnancy resulted in severe heart defects in their infants and have sued GlaxoSmithKline for failure to warn the public about the dangers of the drug for pregnant women. The American College of Obstetricians and Gynecologists recently recommended that pregnant women not use Paxil, according to the plaintiffs’ lawyer, Karen Barth Menzies of ... Read More