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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]
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]
17 Feb 2012, 12:52 pm by Tom Lamb
Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder (Posted by Tom Lamb at The February 14, 2012 email captioned "What's New on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin, Safyral, and Beyaz which consisted of four new sentences being added to the WARNINGS AND PRECAUTIONS section: 5.1 Thromboembolic Disorders and Other Vascular Problems… [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]
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]
16 Jan 2008, 11:37 am
Public Workshop On January 29, 2008 To Focus On Adverse Drug Reaction Reporting (Posted by Tom Lamb at In recent years the FDA has been roundly criticized for its failure to timely recognize emerging drug safety issues. [read post]
28 Aug 2007, 3:36 pm
Organon's Contraceptive Vaginal Ring Uses Etonogestrel, A Metabolite Of Dangerous Progestin Desogestrel (Posted by Tom Lamb at NuvaRing is a contraceptive vaginal ring that was approved by the FDA in October 2001. [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]
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]
1 Dec 2010, 1:55 pm by Tom Lamb
MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs (Posted by Tom Lamb at On November 30, 2010 the Medicines and Healthcare products Regulatory Agency (MHRA) issued two new safety warnings to doctors and other healthcare providers in the UK concerning the cancer drugs Avastin and Sutent. [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]
17 Nov 2008, 10:37 pm
Levine's Drug Injury Situation (Posted by Tom Lamb at I received an email earlier this afternoon from Kyle Murphy, Communications Specialist for the Alliance for Justice (AFJ), in Washington, D.C., that informed me  about two items concerning Diana Levine -- named plaintiff in the relatively well-known Wyeth v. [read post]
2 Oct 2008, 7:54 pm
September 2008 Dear Doctor Letter From Pfizer Follows 2007 EMEA Safety Review Of Cabergoline (Posted by Tom Lamb at Pfizer's Dostinex (cabergoline) remains on the market despite the January 2007 reports in the New England  Journal of Medicine  that Dostinex, like Permax, was linked to valvular heart disease. [read post]
27 Mar 2009, 12:39 pm
The Pharm Tech Blog  Presents A Top 50 List Which Includes Many Fine Pharma Sites, And  Drug Injury Watch (Posted by Tom Lamb at Earlier this week I  learned that  the Drug Injury Watch blog -- which I started in April 2005 -- was listed as one of "The Top 50 Pharmaceutical News and Research Blogs"  by The Pharm Tech Blog. [read post]
26 Aug 2008, 5:51 pm
Ruling By Judicial Panel on Multidistrict Litigation Will Result In Transfer Of All NuvaRing Federal Court Cases (Posted by Tom Lamb at On August 22, 2008 the Judicial Panel on Multidistrict Litigation (JPMDL) granted a petition filed by plaintiffs in 11 NuvaRing federal court lawsuits seeking creation of a NuvaRing multidistrict litigation (MDL). [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]
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]
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]