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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]
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]
28 Jan 2010, 2:00 pm by Tom Lamb
(Posted by Tom Lamb at On January 21, 2010 the Health Research Group arm of Public Citizen sent its "Petition to Ban Fibromyalgia Drug Milnacipran (Savella)" to FDA Commissioner Margaret Hamburg, M.D. [read post]
24 Nov 2010, 10:57 am by Tom Lamb
Johnson and Johnson: Man Ruptured Achilles Tendons In Both Feet After Taking Levaquin (Posted by Tom Lamb at _____________________________________________________________________________ UPDATES: "J&J Loses First Trial on Warnings of Levaquin Risk" (12/8/10, Bloomberg) "Johnson & Johnson Warned on Levaquin Risk, Lawyer Says [During Closing Argument]" (12/6/10, Bloomberg) "Schedin v. [read post]
16 Apr 2012, 12:04 pm by Tom Lamb
QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug (Posted by Tom Lamb at The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been presented best, perhaps, by the ISMP QuarterWatch publication, which served as the basis for these two past articles about the problems with Pradaxa: (1) New Heart Drug Pradaxa May Be Sending "Early" Drug Safety… [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]
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]
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]
13 Oct 2008, 9:59 pm
(Posted by Tom Lamb at In the first part of October 2008 we learned of yet another instance where a drug company chose to put profits over people. [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]
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]
15 Dec 2011, 11:15 am by Tom Lamb
Adverse Event Reports For This New Blood Thinner Drug May Exceed Pre-Approval Clinical Trial Observations (Posted by Tom Lamb at In early December 2011 the FDA announced it is evaluating reports of bleeding in patients taking Pradaxa (dabigatran etexilate mesylate) that have been submitted to the agency's Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than… [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]
7 Aug 2012, 1:05 pm by Tom Lamb
NuvaRing Contraceptive Vaginal Ring Associated With Blood Clots In Arteries That Might Cause Thrombotic Strokes And Myocardial Infarctions (MI) (Posted by Tom Lamb at A Danish study published in June 2012 by The New England of Medicine shows that a woman's use of the NuvaRing birth control product can produce arterial clots leading to a blood-clot related stroke or heart attack. [read post]
5 Nov 2010, 1:14 pm by Tom Lamb
Cases Of Interstitial Lung Disease (ILD) And Rhabdomyolysis / Myopathy Associated With Cholesterol Drugs Known As Statins, Including Zocor  (Posted by Tom Lamb at The October 2010 issue of the Canadian Adverse Reaction Newsletter (CARN) included an article "Statins and interstitial lung disease" which began with these two "Key points": During the last 15 years, 29 cases of interstitial lung disease (ILD) suspected of being… [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]
6 Dec 2011, 8:55 am by Tom Lamb
Expert Reports From YAZ / Yasmin Lawsuits Will Not Be Considered Because Submitted After Deadline Set By FDA (Posted by Tom Lamb at _____________________________________________________________________ UPDATE:  "Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says" (12/8/11, Bloomberg) (12/12/11) _____________________________________________________________________ In October 2011 the FDA released its new drug-safety study report,… [read post]
9 May 2011, 2:13 pm by Tom Lamb
One Sees Mixed Findings About These Fosamax Side Effects From Various Research Reports And Case Studies (Posted by Tom Lamb at Last month we wrote about the status of the thousands of Fosamax lawsuits that have been filed against Merck alleging that the use of this bisphosphonate drug by osteoporosis patients resulted in either atypical low-stress femur fractures or osteonecrosis of the jaw, commonly called ONJ. [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]
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]