This shows that the FDA is more interested in protecting pharmaceutical companies than patients. Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk. A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug. And allowing any… Continue Reading
Category Archives: Public Health
Subscribe to Public Health RSS FeedFDA Requires Warning Label Update for Mirena
Posted in Mirena, RecallsIn May of 2008, the United States Food and Drug Administration required that the warning label for Bayer Pharmaceutical’s Mirena intrauterine contraceptive device be updated to include information regarding the risk for uterine perforation and Mirena migration as a result of then-recent research. Read the FDA-mandated warning update for Mirena here. Currently, Mirena is the world’s most… Continue Reading
Will health insurance co be on the hook for hepatitis claims?
Posted in Lawsuits, Public HealthWay back in 2010, I wrote a blog post about the “prison rape” of one of the companies that manufactured the drugs improperly administered by Dr. Dipak Desai. Now another defendant is on the hook: Officials with Health Plan of Nevada knew in the late 1990s about Desai’s poor reputation after a doctor who was… Continue Reading
Device used to treat patent foramen ovale recalled
Posted in Public Health, RecallsPatent foramen ovale (PFO) is a birth defect that occurs when then a hole between the right and left atria fails to close after birth. It is can be caused by maternal use of SSRI drugs during pregnancy. Anyone unlucky enough to have been born with PFO may now have just been dealt another blow:… Continue Reading
FDA Safety Announcement May Bring New Avandia Lawsuits
Posted in Misc. Drugs, Safety AlertsI 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
Secret payments to doctors put patient lives at risk
Posted in Drug Studies, PoliticsA big part of what I do for a living is investigate the safety of drugs and medical devices. That means I spend time reading studies about the safety of a specific drug. One of the things I look at is the author of the study. If the author of the study discloses that he… Continue Reading
New Bill Would Force Retailers To Notify Consumers of Recalls
Posted in RecallsIf you’re like me, you have a couple of “frequent shopper” cards in your wallet that give you discounts at the grocery stores you frequent. You probably already know that those frequent shopper cards enable retailers to track every purchase you make. And you probably already know that retailers get notified by the FDA when… Continue Reading
Dr. Steve Nissen Pushes For More Scrutiny Of Diabetes Drugs
Posted in Drug Studies, Misc. DrugsLiving legend Dr. Steve Nissen wants the FDA to pay more attention to the cardiovascular risks of diabetes drugs in the future: ORLANDO — Should new diabetes drugs submitted to the FDA have a higher bar for cardiovascular safety than other drugs was the focus of a debate here between Steve E. Nissen, MD, and… Continue Reading
Premium 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
New study shows risk of weight gain for users of antipsychotic drugs
Posted in Drug StudiesMore evidence that certain drugs can cause diabetes… Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs. The study, to be published Wednesday in… 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
Complete List of Recalled Children’s Tylenol
Posted in RecallsYou’ve probably heard that Children’s Tylenol was recalled earlier this month. Fresh from the FDA, here’s the complete list of all products that were recalled. If you have any of them, DON’T USE THEM. 1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg,… 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
More Fentanyl recalls – This Time From Watson Pharmaceuticals
Posted in Duragesic / Fentanyl, RecallsUnlike the previous Duragesic and Fentanyl recalls of millions of patches, this one covers only one lot of one size patch: Watson Pharmaceuticals has recalled one lot of its 75-mcg/hour fentanyl transdermal system in the U.S. because a small number of patches were leaking a gel form of the pain medicine. The recalled patches are… Continue Reading
More Fentanyl patches recalled – not Duragesic this time
Posted in Duragesic / Fentanyl, RecallsWatson Pharmaceuticals has announced a recall of all 75mcg Fentanyl patches from lot number 92461850. These patches are being recalled for the same reason many of Johnson & Johnson’s Duragesic patches were recalled: Manufacturing defects that could lead to leakage. Here’s an excerpt from Watson’s press release: CORONA, CA – August 8, 2008 – Watson… Continue Reading