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目前分類:FDA 公告 (111)

瀏覽方式: 標題列表 簡短摘要

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Xigris 結束了他短短的壽命,就跟他的保存期限一樣

AUDIENCE: Critical Care Medicine

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The US Food and Drug Administration (FDA) today approved tadalafil (Cialis, Eli Lilly), a phosphodiesterase-5 inhibitor, to also treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as a combination of BPH and erectile dysfunction (ED) when the conditions coincide.

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On September 26, 2011, FDA informed the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that looked at the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011 .1,2 FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

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The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). TheContraindicationsWarnings and PrecautionsAdverse Reactions, and Patient Counseling Informationsections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug. 

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The US Food and Drug Administration has granted accelerated approval of brentuximab vedotin infusion (Adcetris, Seattle Genetics, Inc) for the treatment of relapsed or refractory Hodgkin's lymphoma and systemic anaplastic large cell lymphoma.

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The US Food and Drug Administration (FDA) has approved crizotinib (Xalkori, Pfizer) for the treatment of late-stage non-small cell lung cancer (NSCLC) in patients who express the abnormal anaplastic lymphoma kinase (ALK) gene.

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關於acetaminophen的議題還滿多的,請參考:

[Medscape CME] Acetaminophen Use in Adolescents May Double Risk for Asthma
Acetaminophen中毒

N acetylcysteine對Acetaminophen的中毒治療

Acetaminophen與Acetylcysteine併用?

 

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The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.

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The US Food and Drug Administration (FDA) late yesterday approved the first autologous aesthetic cell therapy to improve the appearance of moderate to severe nasolabial fold wrinkles in adults.

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The US Food and Drug Administration (FDA) approved ezogabine (Potiga, Valeant Pharmaceuticals and GlaxoSmithKline [GSK]) as an add-on medication to treat seizures associated with epilepsy in adults.

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 The US Food and Drug Administration (FDA) today approved a sterile, injectable gel called Solesta (Oceana Therapeutics) to treat fecal incontinence in patients after other remedies have failed.

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Safety Announcement

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An FDA review launched in the wake of a controversial 2010 meta-analysis by DrIlke Sipahi (University Hospitals Case Medical Center, Cleveland, OH) et al [1] suggesting an increased risk of cancer among patients taking angiotensin-receptor blockers (ARBs) has concluded that the drugs do not pose a cancer risk to patients [2]. But reacting to the FDA alert to heartwire , Sipahi said he was disappointed with how the FDA conducted its review and, in particular, its failure to do a patient-level analysis.

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5-alpha reductase inhibitors(5-alpha 還原酶抑制劑)有可能會增加罹患前列腺癌的風險嗎?

On June 9, 2011, the U.S. Food and Drug Administration (FDA) informed the public of new safety information for drugs called 5-alpha reductase inhibitors (5-ARIs). Men who take these drugs may have an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). The Warnings and Precautions section of the labels for all FDA-approved 5-ARIs have been revised to include information about this risk.

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The US Food and Drug Administration (FDA) announced today the approval of once-daily rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc) for treatment of HIV infection. Rilpivirine is a nonnucleoside reverse transcriptase inhibitor (NNRTI) that may be taken once daily in combination with other antiretroviral drugs for HIV-infected, treatment-naive patients.

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The US Food and Drug Administration (FDA) today approved linagliptin (Tradjenta, Eli Lilly Co and Boehringer Ingelheim Pharmaceuticals) for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone or in combination with other therapies.

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Safety Announcement

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Compared with vancomycin, fidaxomicin (Optimer Pharmaceuticals, Inc) produces noninferior rates of clinical cure in adults with Clostridium difficile infection. In addition, for some strains, fidaxomicin is associated with a significantly lower rate of recurrence, according to the findings of a randomized trial.

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Dear Healthcare Provider:

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AUDIENCE: Family Practice, Pharmacy, Consumers

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