Blog Archives

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

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 tumors have V600E mutations in the BRAF gene. An estimated 50% of patients with melanoma have this type of BRAF mutation,

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

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 the heart medication Dronedarone [Multaq].

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Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury

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 has also decided to discontinue all ongoing clinical trials.

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

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 risk of heart attack and stroke.

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

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 meningitis. Symptoms of meningitis may include headache,

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

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 with Eltrombopag [Promacta],

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

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 (CHMP) has recommended that marketing authorisations for bufexamac- containing medicines be revoked.

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