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28 Oct 2008, 4:06 pm
October 2008 Federal Register:  FDA Seeks Public Comments On A  New MedWatch Portal; December 22 Deadline (Posted by Tom Lamb at According to a Notice in the October 23, 2008 edition (Volume 73, Number 206) of the Federal Register, the FDA is proposing to change its MedWatch web site and the manner in which it collects information about suspected adverse events involving prescription drugs and other regulated products. [read post]
13 Jan 2009, 2:25 pm
Discusses 16 Cases Of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Erythema Multiforme (EM) Reported Over Two-and-a-half Years (Posted by Tom Lamb at In an October 1, 2008 article, "FDA Alerts Doctors That Revlimid Can Cause Serious Skin Reactions In Patients", we reported that Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Erythema Multiforme (EM) have been associated with the use of Revlimid… [read post]
27 Jul 2009, 12:35 pm
Requests Consolidation Of Federal Court  Lawsuits Alleging Yasmin Or YAZ Caused Injury Such As Stroke, Heart Attack, Pulmonary Thrombosis, Deep Vein Thrombosis, And Death (Posted by Tom Lamb at _____________________________________________________________________ Update:   According to a Notice of Hearing Session issued August 14, 2009 by the U.S. [read post]
13 Mar 2009, 12:23 pm
March 2009 Drug Safety Update Article And BMJ Case Reports Item Bring Attention To Fosamax-Related Atypical Stress Fractures Or Insufficiency Fractures Of Femur (Posted by Tom Lamb at There is an article in the March 2009 edition of the Drug Safety Update (UK) newsletter  that gives us the latest run-down about femur, or thigh bone, fractures in patients using Fosamax (alendronic acid). [read post]
6 Nov 2008, 3:11 pm
Tyco Healthcare Group LP (Covidien) Recall Of ReliOn Disposable Syringes Was First Announced October 9, 2008; FDA Press Release About This Syringe Recall Is Dated November 5, 2008 (Posted by Tom Lamb at By means of an October 9, 2008 letter from ReliOn to its customers, the company announced a recall of a single lot of its syringes sold exclusively at Wal-Mart and Sam's Club stores. [read post]
26 Sep 2008, 7:23 pm
Goodwin Will Preside Over "Double-Dose" Digitek Pill Cases Pursuant To MDL Litigation Order (Posted by Tom Lamb at On August 13, 2008 the Judicial Panel on Multidistrict Litigation (JPMDL) issued an order creating the Digitek products liability multidistrict litigation, In Re: Digitek Products Liability Litigation, MDL No. 1968, JPMDL. [read post]
11 Jan 2008, 7:32 am
Blumsohn Shines His Bright Light On This Troubling Situation And Provides A Lengthy List Of Recent Blog Posts About Zetia And Vytorin (Posted by Tom Lamb at Over at the Scientific Misconduct Blog, Dr. [read post]
8 May 2008, 8:58 am
Women Have Developed Serious Side Effects Like Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) After Using This Birth Control Patch (Posted by Tom Lamb at On May 8, 2008 Public Citizen's Health Research Group (HRG) sent its "Petition to the FDA to Ban Ortho-Evra" to Commissioner Andrew von Eschenbach. [read post]
12 Jun 2012, 2:39 pm by Tom Lamb
Other DRSP Birth Control Pills Which Are Implicated By This New Finding Include Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura (Posted by Tom Lamb at In the February 1, 2012 edition of Current Drug Safetythere is an article, "Irritable bowel syndrome and drospirenone-containing oral contraceptives; a comparative-safety study", which just came to our attention in June 2012. [read post]
3 Apr 2009, 11:45 am
In April 2, 2009 Letter They State There Is "systemic corruption and wrongdoing that permeates all levels of FDA" Which Needs To End(Posted by Tom Lamb at ABC News has posted on their website a slightly redacted copy of an April 2, 2009 letter by nine FDA staffers -- apparently in the FDA's Office of Device Evaluation -- to President Barack Obama. [read post]
3 Jul 2008, 2:20 pm
Medtronic Wants Court To Reject All Injury And Death Cases Based On Riegel Preemption Ruling; Federal MDL Motion To Dismiss Hearing Scheduled For November 2008 (Posted by Tom Lamb at July 3, 2008 online article, "MEDTRONIC: Faces Pending 225 Suits Over Recall of Fidelis Leads", published by Lloyd's Corporate Litigation Reporter, gives us this update on the number of Sprint Fidelis lawsuits that have been filed, and where: Approximately 225… [read post]
22 Jun 2012, 2:30 pm by Tom Lamb
New 2012 Medical Journal Article By North Carolina Orthopedic Surgeon Presents Series Of Femoral Stress Fractures In Patients Using Fosamax Or Other Bisphosphonates (Posted by Tom Lamb at William G. [read post]
2 Feb 2010, 1:20 pm by Tom Lamb
Merck Lost Its Attempt To Have Louise Maley's Fosamax Lawsuit Dismissed Before Her April 19, 2010 Trial Date (Posted by Tom Lamb at We have been reporting about the three bellwether trial cases for the federal court Fosamax MDL and, in this article, we continue to do so. [read post]
6 Jul 2007, 9:20 am
Avandia Seems Associated With Increased Rate Of Heart Failure; Less Clear Whether Glaxo's Diabetes Drug Causes Heart Attacks, Other Cardiovascular Problems (Posted by Tom Lamb at In the July 5, 2007 edition of The New England Journal of Medicine (NEJM) there are several editorials of interest to those doctors and patients who are concerned about the heart safety of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone). [read post]
17 Oct 2008, 12:54 pm
Company Will Pay $745 Million In Settlements To Conclude 90% Of These Lawsuits (Posted by Tom Lamb at An October 17, 2008 Wall Street Journal (WSJ) article, "Pfizer to Settle Celebrex and Bextra Suits", broke the news and provided the details: Pfizer Inc. has agreed in principle to pay $894 million to settle litigation related to its painkillers Celebrex and Bextra. [read post]
22 Jul 2009, 2:45 pm
July 2009 Pediatrics Medical Journal  Article Finds Most Cases Involved Infants Less Than One Year Of Age (Posted by Tom Lamb at The article "Cardiovascular Medication Errors in Children" was published in the July 2009 edition of the medical journal Pediatrics. [read post]
17 Apr 2007, 10:46 am
Amgen-Sponsored Study Was Testing Aranesp In Cancer Patients Who Developed Anemia (Posted by Tom Lamb at An April 17, 2007 Wall Street Journal (WSJ) article about the results of a new study concerning Aranesp revealed more bad news for Amgen Inc., the maker of this anemia drug:Amgen's drug Aranesp didn't reduce the need for blood transfusions in anemic cancer patients and was linked to a nearly 45% increase in deaths compared with patients taking a… [read post]
24 Sep 2009, 1:09 pm
Medical Journal Article Points To Imbalance Between Bone Resorption And Bone Formation At Affected Bone (Posted by Tom Lamb at In the October 2009 edition of the Journal of Bone and Mineral Research we found an article which advances the epidemiology of bisphosphonate-related femur fractures. [read post]
16 May 2008, 7:30 am
Six Months After It Announced Start Of This Investigation, FDA Gives An Update On Status Of Maxipime Safety Review (Posted by Tom Lamb at In mid-November 2007 the FDA announced the start of its investigation into the safety of Maxipime (cefepime), and said their safety evaluation should take about four months to complete. [read post]
13 Jan 2011, 1:55 pm by Tom Lamb
2011 Raptiva Lawsuit Filed In Texas Against Drug Company: Failure To Warn About Side Effect Risks (Posted by Tom Lamb at in 2009 we told you about some of the developments which led to Raptiva being withdrawn from the market in these two articles: -- A Timeline For The Psoriasis Drug Raptiva, From Product Launch In U.S. [read post]