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21 Apr 2009, 2:20 pm
(Posted by Tom Lamb at On April 17, 2009 we learned that another multiple-sclerosis patient using the multiple-sclerosis (MS) drug Tysabri developed progressive multifocal leukoencephalopathy, or PML, a rare brain infection. [read post]
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 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 by Tom Lamb
Medical Clues Include Prior Symptoms, Location Of Thigh Bone Break, And Specific Radiology Findings (Posted by Tom Lamb at 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 by Tom Lamb
Highest Simvastatin Dosage Linked To Potentially Fatal Rhabdomyolysis Muscle Injury And Kidney Failure  (Posted by Tom Lamb at 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 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 by Tom Lamb
Level Of Concern About These Incretin Therapies For Diabetes Was Raised By Gastroenterology Medical Journal Article (Posted by Tom Lamb at 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 by Tom Lamb
ISMP Quarterwatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA (Posted by Tom Lamb at ______________________________________________________________________________ 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 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 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 by Tom Lamb
Public Citizen March 2011 Letter To FDA Points To Aclasta Safety Alert Material Sent In Canada During October 2010 (Posted by Tom Lamb at 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 by Tom Lamb
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening (Posted by Tom Lamb at 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 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 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 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 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 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 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 by Tom Lamb
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure  (Posted by Tom Lamb at 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 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 by Tom Lamb
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 Stevens-Johnson syndrome (SJS) was first described in 1922, and toxic epidermal necrolysis (TEN) was first described in 1956. [read post]