I got an email from the FDA alerting me to new warnings about the usage of Avandia. Apparently, the FDA has not decided to withdraw Avandia, but is severely restricting who may use it: FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS…. Continue Reading
Category Archives: Safety Alerts
Subscribe to Safety Alerts RSS FeedPremium Edge Cat Food Recalled
Posted in Recalls, Safety AlertsIf you have a furry little friend who eats Premium Edge cat food, you’ll want to read this: On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the… Continue Reading
More on the link between Meridia and cardiovascular events
Posted in Misc. Drugs, Safety AlertsAs always, consult your doctor before you even think about taking yourself off a drug. WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety review of the weight-loss drug Meridia, which is made by Abbott Laboratories (ABT). The FDA siad it was reviewing preliminary data from a recent study… Continue Reading
New Warning for Users of Meridia
Posted in Misc. Drugs, Safety AlertsThis is fresh from the FDA. If you’re using Meridia (Sibutramine) you may want to bring this up with your doctor: FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest,… Continue Reading
New Information About Drugs Used In Shoulder Pain Pumps
Posted in Misc. Drugs, Safety AlertsOne area I haven’t written much about yet is the association of chrondrolysis with drugs used in certain shoulder pain pumps. Here’s some fresh information on that topic from the FDA: FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with… Continue Reading
Some Lots of Vicks Sinex Nasal Spray Recalled
Posted in Safety AlertsIf you have any Sinex Nasal Spray, you should check to make sure it’s not one of the recalled bottles: Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in… Continue Reading
Do you take Plavix and Prevacid? Then read this warning.
Posted in Safety AlertsFresh from the FDA a few minutes ago… [Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of… Continue Reading
NO – You Can NOT Eat a Fentanyl Patch
Posted in Duragesic / Fentanyl, Safety AlertsPeople keep finding my blogs by searching for things like "Can you eat a fentanyl patch?" NO! Eating a fentanyl patch has a VERY good chance of killing you. The patches are designed to deliver fentanyl at a constant amount over a period of three days. Eating it will give you the full dose all… Continue Reading
News about link between Byetta and acute renal failure
Posted in Safety AlertsJust got this in my email from the FDA: Byetta (exenatide) – Renal Failure Audience: Endocrine and nephrology healthcare professionals 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… Continue Reading
Rituxan and progressive multifocal leukoencephalopathy
Posted in Safety AlertsFrom the FDA: Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have… Continue Reading
Warning About Iron Dextran Injections
Posted in Misc. Drugs, Safety AlertsI don’t always post FDA alerts, but when one involves possible fatalities, I do. [Posted 10/16/2009] American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose… Continue Reading
FDA Issues Warning on Progressive Multifocal Leukoencephalopathy (PML) and Tysabri
Posted in Misc. Drugs, Safety AlertsDo you subscribe to FDA warning alerts? Well, if not, you should. Because if you did you’d get informative emails like this one: Audience: Neurological healthcare professionals, patients [Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing… Continue Reading
Black Box Warning for Amputation Finally Ordered
Posted in Preemption, Safety AlertsIt came a little late for Diana Levine, but at least it finally came. TRENTON, N.J. — Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug… Continue Reading
Duragesic / Fentanyl patients should stay away from grapefruit, heat
Posted in Duragesic / Fentanyl, Safety AlertsIn February, the FDA approved changes to the warning label for the Duragesic (Fentanyl) pain patch, including adding warning patients using the patch not to drink grapefruit juice or expose the patch to a direct heat source. Dose increases should be approached with caution, and patients should avoid grapefruit or grapefruit juice… (Emphasis added.) …. Continue Reading
Digitek (Digoxin) Recall Information
Posted in Misc. Drugs, Recalls, Safety AlertsSafety Alert: Digitek Recalled in April of 2008 On April 25th of 2008, Actavis Totowa, LLC announced a Class I Recall of Digitek tablets. A Class I Recall occurs when there is an immediate risk of death or injury from a drug or medical device. In this case, Actavis announced the recall because certain batches… Continue Reading