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Food and Drug Administration 233 articles

Cause of debilitating skin condition suggested

New findings from researchers at Wake Forest University Baptist Medical Center and colleagues suggest why some people with kidney failure can develop a rare tightening and swelling of the skin and other organs, including the lungs and heart. Reporting in the October issue of the American Journal of Dermatopathology, the authors suggest a possible explanation for why some patients on kidney dialysis who are injected with a “contrast agent” during a magnetic resonance imaging (MRI) develop nephrogenic systemic fibrosis (NSF). The U.S. Food and Drug Administration now requires a warning about the potential risk on the products’ labels. NSF leads ... 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

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

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

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

Blood pressure pill doubles risk of birth defects

Some blood pressure drugs previously thought to be safe when taken early in pregnancy now appear to substantially raise the risk of major birth defects, doctors say. Babies whose mothers took ACE inhibitors in their first trimester were more than twice as likely to be born with serious heart and brain problems than those not exposed to any pressure-lowering medicines, a large study in Tennessee found. Other types of blood pressure drugs did not raise the risk to babies. The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women. About 8 percent ... Read More

Updated Product Labeling Warns of Birth Defect

The U.S. Food and Drug Administration (FDA) recently announced that early research studies with the drug Paxil (paroxetine) suggest that taking the drug during the first three months of pregnancy may increase a woman’s risk of having a baby with birth defects, particularly heart defects. Paxil is an antidepressant drug belonging to the class of medications known as the selective serotonin reuptake inhibitors (SSRIs). Drugs in this group affect levels of the chemicals that nerves in the brain use to communicate with one another, known as neurotransmitters. Many experts believe that an imbalance among the amounts of the different neurotransmitters ... Read More