Archive for July, 2009

FDA warns against body-building products claiming steroids

Body Building SupplementsThe Food and Drug Administration warned the public Tuesday not to use body-building products marketed as containing steroids or steroid-like substances. “Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said the agency’s commissioner, Dr. Margaret Hamburg.

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Study uncovers potential Avandia liver failure risk

An analysis of adverse events reported to the Food and Drug Administration has uncovered 11 deaths due to liver toxicity among patients taking the diabetes drug Avandia. The consumers group Public Citizen, which conducted the analysis, estimates that because few side effects cases are reported to the FDA, the actual number of patients who developed liver failure after using Avandia could be much higher.

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Young You Corporation Issues a Voluntary Nationwide Recall of Weight Loss Pills

Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown.  All lots of the following dietary supplement products are being recalled: Slimbionic, One Weight Loss Pill 30 capsules, SlimDemand Capsules, and Botanical Weight Loss.

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Brazil ordered to compensate thalidomide victims

A federal court has ordered the Brazilian government to compensate children of mothers who took thalidomide, a drug that caused birth defects in thousands of people across the world but was withdrawn tardily in Brazil. Thalidomide was introduced in Brazil in 1957 as an anesthetic against discomforts experienced during pregnancy, but as elsewhere it resulted in severe fetal congenital defects among users.

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Manufacturer recalls drug central to Jackson death probe

The manufacturer of propofol has announced that it is recalling two lots of the anesthetic drug after they were linked to dozens of cases of bacterial contamination. Teva Pharmaceuticals was also recently contacted by federal officials investigating the death of Michael Jackson over concerns that the pop singer may have taken Diprivan—the brand-name version of propofol—before his death.

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FDA scrutinizing safety of asthma drug Xolair

XolairThe Food and Drug Administration announced Thursday it is conducting a safety review of the asthma drug Xolair after data from an ongoing study suggested an increased number of heart attacks and strokes among patients who use it. The data “suggest a disproportionate increase in ischemic heart disease, arrhythmias … cardiac failure” and other conditions “in patients treated with Xolair compared to the control group of patients not given the drug,” the agency said.

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Hormone Therapy Raises Ovarian Cancer Risk

Women who are on hormone therapy or who have used it in the recent past are at higher risk of ovarian cancer than women who have never been on hormone therapy, a new study shows. The increase in risk was found regardless of the hormone dose or formulation, whether hormones were taken by mouth, transdermal patch, or vaginally, or whether the treatment included just estrogen or estrogen and progestin, the researchers say.

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Brookstone Pharmaceuticals Issues a Voluntary Recall of All Lots of Brookstone Pharmaceuticals’ Concentrated Acetaminophen Drops

Brookstone Pharmaceuticals has initiated a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing.

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Medtronic recalls some Paradigm sets used by diabetics

Minimed Paradign insulin pumpsMedtronic Inc  said it was recalling specific lots of its Paradigm Quick Set infusion sets that are used with Minimed Paradign insulin pumps because they may not work properly. The company said on Friday it recently discovered that about 60,000, or 2 percent of the infusion sets of “lot 8″, may not allow the insulin pump to vent air pressure properly.

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Canada examines cancer risks of diabetes drug

The Canadian Health Ministry announced a review into whether diabetes drug Lantus, one of the most widely sold drugs worldwide by pharmaceutical giant Sanofi-Aventis, increases the risk of cancer. Similar reviews have already been launched by the US Food and Drug Administration and the European Medicines Agency after four studies examining the relationship between the drug and cancer incidence were published.

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