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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

ACOG Issues Opinion on SSRI Antidepressant Use During Pregnancy

Washington, DC — The use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for the treatment of depression during pregnancy should be individualized based on their respective risks and benefits, according to a new Committee Opinion issued by The American College of Obstetricians and Gynecologists’ (ACOG) Committee on Obstetric Practice. The Committee also advised that a particular SSRI medication known as paroxetine (Paxil®) be avoided, when possible, by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects. Reproductive-age women have the ... Read More

Ob/Gyn Group Urges Pregnant Women to Shun Paxil

A group representing America’s obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects. The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis. ACOG’s Committee on Obstetric Practice “recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible,” read the statement, which ... Read More