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14 Feb 2008, 2:44 pm
January 2008 Health Canada Newsletter Presents These Adverse Reaction Cases, And Announces "Canada Vigilance" (Posted by Tom Lamb at The Canadian Adverse Reaction Newsletter (CARN), in its January 2008 edition (Volume 18, Issue 1), has two articles of interest regarding side effects associated with birth control products that are alternatives to oral contraceptives. [read post]
21 Jan 2008, 2:50 pm
Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008 (Posted by Tom Lamb at On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix. [read post]
28 Apr 2008, 9:03 am
After Their Medications Get Approved By FDA, Many Drug Companies Have Not Yet Started The Studies Which They Promised To Do (Posted by Tom Lamb at Each year the FDA issues what could be called a "report card" on how the pharmaceutical companies are doing as regards post-approval studies for their products that have been approved for sale in the U.S. [read post]
19 Jan 2008, 3:29 pm
Label For "The Patch" No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots (Posted by Tom Lamb at A January 18, 2008 WebMD article, "Stronger Warning for Birth Control Patch", provided a concise summary of the latest news about the Ortho Evra Contraceptive Transdermal (Skin) Patch manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson (JNJ):The FDA today strengthened… [read post]
5 Dec 2008, 4:00 pm
Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled (Posted by Tom Lamb at In an August 26, 2008 Drug Injury Watch post, "FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility", I reported FDA inspectors found that Sandoz had failed to properly validate its manufacturing process for Metoprolol Succinate… [read post]
16 Oct 2008, 7:17 pm
First It Was Their Morphine Tablets; Now ETHEX Dextroamphetamine 5mg Pills May Be Oversized And Contain Two Times The Active Ingredient (Posted by Tom Lamb at By means of an October 16, 2008 MedWatch Email Alert the FDA announced that ETHEX Corporation has recalled three lots of Dextroamphetamine Sulfate 5mg tablets because of the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. [read post]
10 Feb 2012, 10:38 am by Tom Lamb
At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (Posted by Tom Lamb at We first reported about Pradaxa (dabigatran) back in October 2011 in this article "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals". [read post]
14 Jan 2008, 8:49 am
Long-Awaited Results Of ENHANCE Study Show Zocor + Zetia (= Vytorin) Does Not Improve Patient Outcomes (Posted by Tom Lamb at A January 14, 2008 Bloomberg article, "Merck, Schering's Vytorin No Better Than Generic (Update 2)", reported the long-awaited results of a study concerning Zetia and Vytorin as well as the immediate fall-out:  Merck & Co. and Schering-Plough Corp. said their combination cholesterol drug Vytorin… [read post]
1 Dec 2011, 2:02 pm by Tom Lamb
Coincidence, But Ironic, Given Several Recent Medical Studies Which Suggest Drospirenone (DRSP) Causes Blood Clots (Posted by Tom Lamb at On November 29, 2011 Watson Pharmaceuticals issued this press release, "Watson's Generic Yaz(R) Receives FDA Approval", which begins as follows: Watson Pharmaceuticals, Inc. [read post]
13 Dec 2007, 10:16 am
Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE) (Posted by Tom Lamb at An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing ®. [read post]
25 Nov 2008, 6:45 pm
One May Start There, But Be Sure To  Check More Comprehensive Online Sites Such As And (Posted by Tom Lamb at A November 25, 2008 Reuters Health article, "Wikipedia often omits important drug information: study", by reporter Anne Harding, had this precautionary advice for people who are are looking for information about  their prescription drugs or over-the-counter medications: Consumers who… [read post]
8 Feb 2011, 11:25 am by Tom Lamb
In Addition To The Federal Court Fosamax Jaw Injury Lawsuits Set For Trial In March 2011 And May 2011 (Posted by Tom Lamb at UPDATE:  Order by Federal Court Fosamax MDL Judge John F. [read post]
25 Oct 2010, 11:10 am by Tom Lamb
Novartis Sends "Dear Doctor" Letter To Canadian Physicians With Health Canada Endorsed Safety Information (Posted by Tom Lamb at In 2007 Aclasta (zoledronic acid 5mg) was approved by the FDA under the brand name Aclasta® Injection as the first and only once-yearly medicine for postmenopausal osteoporosis. [read post]
8 Mar 2011, 7:54 am by Tom Lamb
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at In early March 2011 the FDA announced that the prescribing information for Topamax and generic topiramate products would be changed to warn women and their doctors about an increased risk of oral cleft birth defects in children whose mothers used these epilepsy and migraine drugs during pregnancy. [read post]
31 Jul 2012, 12:03 pm by Tom Lamb
Almost 2,000 Lawsuits With Blood Clots Such As DVT And PE Settled, With At Least Another 4,000 Such Cases In Settlement Mediation Negotiations (Posted by Tom Lamb at From Bayer's Stockholders' Newsletter Second Quarter 2012 (PDF format), at page 50, we get the following update on the Gianvi / Ocella / Yasmin / YAZ litigation: As of July 19, 2012, the number of lawsuits pending in the United States and served upon Bayer was about 12,325 involving… [read post]
4 Apr 2011, 1:15 pm by Tom Lamb
Merck ONJ Trial Set For May 2011 (Posted by Tom Lamb at _____________________________________________________________________UPDATE: On May 23, 2011 the U.S. [read post]
5 Feb 2009, 6:32 am
FDA List Is Based On Reports Made To Adverse Event Reporting System (AERS) Between July And September 2008 (Posted by Tom Lamb at On February 4, 2008 the FDA posted on its web site a new list of prescription drugs it will be studying for potential safety problems. [read post]
8 Sep 2011, 11:04 am by Tom Lamb
Osteonecrosis Of The Jaw, Or Jawbone Death, And Atypical Femur Fractures, Or Low-Stress Thigh Bone Breaks, Are The Primary Drug-Safety Issues (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE:  Warner, Merck Bone Drugs Need Label Changes on Use Duration, Panel Says (9/9/11, Bloomberg) FDA Panel: Osteoporosis Drugs Need Better Labels (9/9/11, WebMD Health News)Time Limits on the Drugs Are… [read post]
24 Apr 2012, 1:04 pm by Tom Lamb
Recent Medical Article And Poster Presentation Both Point To A Trend Toward Increased Rate Or Risk Of Myocardial Infarction (MI) (Posted by Tom Lamb at  A recent "position paper" by a group of experts from the European Society of Cardiology (ESC) Working Group on Thrombosis provides an update on the side effects associated with Pradaxa (dabigatran). [read post]
9 Mar 2012, 3:06 pm by Tom Lamb
Jury Is Told Numerous Times By Her Attorney That Fosamax Did Nothing For Sessner, It Only Did Something To Her (Posted by Tom Lamb at During his March 5, 2012 opening statement the plaintiff's attorney, Tim O'Brien, told members of the jury numerous times that Fosamax did nothing for Jo Ann Sessner, it only did something to her. [read post]