August 17, 2011 — The US Food and Drug Administration (FDA) has just approved the oral targeted therapy Vemurafenib [Zelboraf] for the first-line treatment of both metastatic and unresectable melanomas. The drug is specifically indicated for patients with melanoma whose …

Vemurafenib [Zelboraf] Approved Together with a Companion Diagnostic Test by FDA for Advanced Melanoma in BRAF V600E Positive Patients Read more »

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January 14, 2011 – The American Food and Drug Administration (FDA) notified today healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with …

Heart Medication Dronedarone [Multaq]: Risk of Severe Liver Injury Read more »

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December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer …

Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury Read more »

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October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased …

Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events Read more »

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2010-08-15 – From a recent health safety alert  we learn that  FDA notified healthcare professionals and patients that Lamotrigine [Lamictal], a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic …

Lamotrigine [Lamictal]: DrugLabel Change Because Risk of Aseptic Meningitis Read more »

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May 13, 2010 – The American Food and Drug Administration (FDA) posted yesterday the following Safety Information Text (italic): GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated …

Eltrombopag [Promacta]: Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease Read more »

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April 27, 2010 – From an announcement by the EMEA we learn that bufexamac-containing medicines were to be taken off EU markets because of high risk of contact allergies. The European Medicines Agency’s Committee for Medicinal Products for Human Use …

European Medicines Agency (EMEA) recommends revocation of marketing authorisation for bufexamac containing medicines. Read more »

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