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23 Sep 2008, 9:34 pm
FDA To Collaborate With Complaining Patients On Study Of Reported Problems With This Generic Version Of Antidepressant Wellbutrin XL (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a September 23, 2008 Wall Street Journal (WSJ) article, "Wellbutrin Generic to Get New Review", we learned that the FDA is going to re-visit the issues of whether Budeprion XL -- which is made by Impax Laboratories Inc. and distributed by Teva Pharmaceutical Industries Ltd. -- is as… [read post]
6 Oct 2011, 1:55 pm
Medical Clues Include Prior Symptoms, Location Of Thigh Bone Break, And Specific Radiology Findings (Posted by Tom Lamb at DrugInjuryWatch.com) For this medical primer about femur fractures which might be associated with Fosamax as well as the several other bisphosphonate osteoporosis medications available in the U.S. we will start with some basic anatomy taken from a document titled "Femur Shaft Fractures (Broken Thighbone)", published by the American Academy of Orthopaedic… [read post]
10 Jun 2011, 2:52 pm
Highest Simvastatin Dosage Linked To Potentially Fatal Rhabdomyolysis Muscle Injury And Kidney Failure (Posted by Tom Lamb at DrugInjuryWatch.com) On June 8, 2011 the FDA announced new dosing restrictions for Zocor and other prescription drug pills containing 80 milligrams (mg) of simvastatin due to their determination these cholesterol drugs are associated, or linked, with an increased risk of developing myopathy and rhabdomyolysis, a serious muscle injury usually requiring… [read post]
1 May 2009, 10:45 am
Reports Made To The FDA Have Involved Hepatitis, Liver Failure, Liver Transplant, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) On May 1, 2009 the FDA warned people to stop using Hydroxycut products -- made by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- due to the fact that some Hydroxycut products are associated with a number of serious liver injuries. [read post]
17 Nov 2011, 12:18 pm
Level Of Concern About These Incretin Therapies For Diabetes Was Raised By Gastroenterology Medical Journal Article (Posted by Tom Lamb at DrugInjuryWatch.com) In September 2011, at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting, Diabetes Medical Congress, in Lisbon, Portugal, there was a debate about whether there is an increased risk of pancreatitis, pancreatic cancer, and thyroid cancer for patients who use Januvia (sitagliptin) or Byetta… [read post]
13 Oct 2011, 6:23 am
ISMP Quarterwatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Boehringer says about 260 deaths related to Pradaxa" (11/12/11, Reuters) FRANKFURT Nov 12 (Reuters) - Boehringer Ingelheim said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa so far, adding that the risk of… [read post]
14 Aug 2008, 9:50 pm
Most Of These Product Liability Cases Allege Fosamax Caused Drug-Induced Osteonecrosis Of The Jaw (ONJ) (Posted by Tom Lamb at DrugInjuryWatch.com) According to an August 14, 2008 "MERCK & CO: Faces 655 Product Liability Cases Over Fosamax Drug", published by Lloyds Corporate Litigation Reporter: Merck & Co., Inc., as of June 30, 2008, faced approximately 655 product liability cases involving Fosamax drug, including about… [read post]
22 May 2009, 11:24 am
Agency Has Received Case Reports Of Hepatotoxicity For Orlistat, The Active Ingredient For Xenical And Alli (Posted by Tom Lamb at DrugInjuryWatch.com) There was only this brief mention in the Memorandum of Meeting Minutes for the FDA's April 16, 2009 Drug Safety Oversight Board Meeting: The Drug Safety Oversight Board (DSB) discussed two topics: the product orlistat and the potential risk of hepatotoxicity and alcohol-based skin antiseptics and the risk of a fire in the… [read post]
11 Apr 2011, 12:04 pm
Public Citizen March 2011 Letter To FDA Points To Aclasta Safety Alert Material Sent In Canada During October 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) To start, Reclast is the U.S. name for the zoledronic acid medication sold by Novartis; it is identical to Aclasta, which Novartis sells in Canada. [read post]
12 Sep 2012, 1:45 pm
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening (Posted by Tom Lamb at DrugInjuryWatch.com) Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial fibrillation or atrial flutter). [read post]
2 Sep 2009, 11:46 am
August 2009 Medical Journal Article Presents Well-Documented Report Of Pancreatitis In Context Of Byetta Use (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2007 the FDA announced that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. [read post]
20 Aug 2008, 8:04 pm
Various Parties Have Filed Briefs With Their Arguments About Whether Or Not An Injured Patient Should Be Able To File A Lawsuit Against The Drug Company (Posted by Tom Lamb at DrugInjuryWatch.com) As some of you are aware by now, this fall the Supreme Court will hear oral arguments in the case Wyeth v. [read post]
19 Jun 2009, 12:29 pm
Doctors Should Inform Their Patients About Potential Serious Side Effects Like Osteonecrosis Of The Jaw And Femur Fractures (Posted by Tom Lamb at DrugInjuryWatch.com) The rather alerting headline above comes from an article, "Osteoporosis treatments and adverse events", which was published in the April 30, 2009 edition of Current Opinion in Rheumatology. [read post]
26 Apr 2007, 2:58 pm
Findings Of April 2007 AHRQ Report On Side Effects And Other Medication Problems In American Hospitals (Posted by Tom Lamb at DrugInjuryWatch.com) A recent online article provided a summary of the findings from the "Adverse Drug Events in U.S. [read post]
27 Jan 2009, 3:00 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) In the most recent FDA Drug Safety Newsletter (Volume 2, Number 1, 2009) we found a report, "Atomoxetine (Marketed as Strattera): Serious Liver Injury", that is rather disturbing insofar that the majority of patients at risk are children. [read post]
10 May 2007, 7:41 am
(Posted by Tom Lamb at DrugInjuryWatch.com) Natrecor (nesiritide) is approved for the treatment of patients with acutely decompensated heart failure who suffer from symptoms at rest or with minimal exertion. [read post]
3 Mar 2011, 12:58 pm
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure (Posted by Tom Lamb at DrugInjuryWatch.com) The association between the antibiotic Zithromax (azithromycin) and drug-induced liver failure first received some real attention in 2010. [read post]
18 Mar 2009, 11:56 am
Risk Is Greatest For Elderly, Especially Older Women, And Long-Term Users Of This Popular Gastrointestinal Medication (Posted by Tom Lamb at DrugInjuryWatch.com) On February 26, 2009 the FDA sent by email a MedWatch Alert, "Metoclopramide-containing drugs: chronic use linked to tardive dyskinesia", which included this information: FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a… [read post]
30 Dec 2010, 11:30 am
SJS And TEN Differ In The Extent Of Skin Detachment, But Both Are Severe And Life-Threatening Drug Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) Stevens-Johnson syndrome (SJS) was first described in 1922, and toxic epidermal necrolysis (TEN) was first described in 1956. [read post]
29 May 2008, 7:43 am
Confusion Between Similar Drugs Is A Cause Of Medication Errors That Agency Will Focus On In New Pilot Program (Posted by Tom Lamb at DrugInjuryWatch.com) To start, we get this background information from "Medication Errors: FDA 101", which was posted March 14, 2008 on the FDA's web site: A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. [read post]
