Hospira Recalls Propofol Products Containing Steel Particles

Hospira Inc. is recalling certain dietary supplements and anesthesia products because some may contain stainless steel particles that could restrict blood flow and lead to heart attacks or death. Hospira said it’s recalling 85 lots of its fat emulsion products Liposyn, used in infants and others who are unable to get fat in their diet, according to a press release the U.S. Food and Drug Administration posted on its Web site. The press release is from Hospira, not the FDA. Hospira, based in Lake Forest, Ill., is also recalling certain lots of injectable propofol, which is used to sedate patients.

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FDA warns of link between Byetta (exenatide) and Renal Failure

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

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Antipsychotics Cause Weight Gain in Kids

Antipsychotic drugs widely used in children caused youths to gain as much as 19 pounds on average after just 11 weeks on the medications, according to a new study published in the Journal of the American Medical Association. The findings about the drugs, known as atypical antipsychotics, bolster concerns about giving the medicines to patients under 18 years of age. The drugs examined were four top-selling atypical antipsychotics: Abilify, sold by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.; Risperdal from Johnson & Johnson; Seroquel from AstraZeneca PLC; and Zyprexa from Eli Lilly & Co.

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Study finds rapid weight gain among children taking Zyprexa, Risperdal, Seroquel

Children and adolescents who are prescribed a type of psychiatric drug known as atypical antipsychotics face an increased risk of rapid weight gain and other metabolic changes, according to a new study in the Journal of the American Medical Association. According to the authors of the study, these changes could increase the children’s risk of diabetes, hypertension or other related conditions.

The JAMA study examined the effects of four atypical antipsychotic drugs on children—Zyprexa, Risperdal, Seroquel and Abilify. Atypical antipsychotics are prescribed to treat a number of conditions, including schizophrenia and bipolar disorder. Of the four drugs, only Risperdal and Abilify have been approved by the Food and Drug Administration for treating children.

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Industry Years Behind on Testing Approved Drugs

Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised. The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial.

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