the glocalized network in theragenomic and personalized medicine and the genetics of individual patients safety of drugs
December 12, 2014 – The American Food & Drug Administration (FDA) has recently issued a warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can …
Rare But Potentially Fatal Skin Reactions (DRESS Syndrome) with Ziprasidone [Geodon] Read more »
November 7, 1014 – This report originates from the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) on 3-6 November 2014 at EMA. At this meeting, the PRAC took note and advised on informing about first case of PML in a patient …
September 27, 2014 – A while ago (August 2012), the American Food and Drug Administration (FDA) was assessing and reporting on the (possibly fatal) risks associated with the use of codeine containing medicines in children who are phenotypically members of the …
July 22, 2014 – Over and over again do we read announcements by the American Food and Drug Administration (FDA) such as the most recent one below. The producers and vendors of this type of “health” products put patients knowingly …
Weight Loss Products: Public Notification – Undeclared Drug Ingredients Read more »
May 27, 2014 – Health Canada informed us today that rare cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients treated with Panitumumab (Vectibix), and advises as follows: Cases of Stevens-Johnson syndrome (SJS) and Toxic …
May 13, 2014 – The Pradaxa story continues. See the latest MedWatch Drug Safety Communication, posted on 05/13/2014. ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding …
April 13, 2014 – The American Food and Drug Administration (FDA) has issued a new Boxed Warning for Valproic Acid [Stavzor] and its association with drug induced liver disease (hepatotoxicity, hepatic failure) which may be fatal in some patients. We …
Valproic Acid [Stavzor]: Newly issued boxed warning for life-threatening liver disease Read more »
March 31, 2014 – The American Food and Drug Administration (FDA) is clarifying its previous recommendation related to prescribing Sidenafil [Revatio] for children with pulmonary arterial hypertension (PAH). Note that the pharmacologically active compound sildenafil is also the pharmacologically active …
June 26, 2013 – The American Food and Drug Administration (FDA) has just released (June 06 2013) the following important information concerning patients who receive hydroxyethyl Starch (HES) solutions in the course of their treatment. ISSUE: FDA has analyzed recent …
May 09, 2013 – We have just stumbled upon a recent press release to the public by the American Food and Drug Administration (FDA) on a looming drug safety problem of incretin mimetic drugs related to the pancreas. Find here …