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Pharmaceutical 7375 articles

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

First Paxil birth defect lawsuit filed

The parents of 2-year-old Eric Jackson have filed the first lawsuit claiming that use of the antidepressant Paxil during pregnancy caused birth defects in their won. Christopher Jackson and Lisa Boden of Denver claimed the medication – manufactured by GlaxoSmithKline – caused their son to be born with severe PPHN (Persistent Pulmonary Hypertension), a condition that affects blood flow to the lungs and can cause death. After his birth in Denver, Eric was placed on a ventilator for a month, and had two cardiac catherizations and several other procedures. He remains on oxygen and medications to help him breathe. The ... 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

Paxil Maker Sued Over Child Born with Severe Birth Defects

The parents of a two-year old boy have filed a lawsuit against the maker of Paxil, alleging that the mother’s use of the antidepressant during pregnancy cause her son to be born with severe heart defects. Anthony and Matilda Vasquez of Bedford, Texas, sued Philadelphia- based Glaxo-SmithKline on behalf of their son, Adrian. The lawsuit, filed in Pennsylvania state court, is seeking unspecified damages for failing to warn pregnant women about the risks of taking Paxil. During the last month of her pregnancy, Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something ... Read More

Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns

Decisions about how to treat depression in pregnant women are increasingly complex. Patients and physicians must carefully consider and discuss together the potential benefits and risks of treatment with antidepressants during pregnancy. Two new studies provide important information to be considered in making such decisions. The studies included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI medications are the most commonly used drugs to treat depression in the U.S. The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during ... Read More