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28 Sep 2011, 1:43 pm
Possibly Increased Risk Of Blood Clot-Related Side Effects Like PE And DVT Suggested By Postmarketing Studies (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Ortho Evra Update: October 2011 FDA Study Finds Increased Risk Of Serious Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (11/2/11) _____________________________________________________________________ On… [read post]
26 Sep 2011, 12:46 pm
Early Results Suggest An Approximately 1.5-fold Increase In The Risk For Birth Control Pills With Drospirenone (DRSP) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack (11/2/11) _____________________________________________________________________ UPDATE: New… [read post]
22 Sep 2011, 12:00 pm
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2011 the European Medicines Agency (EMA) recommended that the use of Sanofi's antiarrhythmic medication Multaq (dronedarone) be restricted to certain patients with paroxysmal or persistent atrial fibrillation. [read post]
16 Sep 2011, 2:24 pm
Safety Problems With New Medications Often Appear Only After Approval And Widespread Use (Posted by Tom Lamb at DrugInjuryWatch.com) A medical journal article published in the September 12, 2011 edition of the Archives of Internal Medicine has given some profile to the myth that just because the FDA has approved a prescription drug it must be safe to use. [read post]
8 Sep 2011, 4:21 pm
Molson, Tom “durrrr” Dwan, Ben Lamb, and Joseph Cheong. [read post]
8 Sep 2011, 11:04 am
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 DrugInjuryWatch.com) ______________________________________________________________________________ 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]
1 Sep 2011, 2:55 pm
Generic Drug Companies Should Have To Update Side Effect Warnings Or Face Drug Injury Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) On August 29, 2011 the consumer advocacy group Public Citizen took action in an attempt to (1) require generic drug companies to warn about serious side effects caused by their prescription medications, and (2) to gain back for patients harmed by a generic medicine the right to file a drug injury lawsuit. [read post]
25 Aug 2011, 2:02 pm
Federal Court Judge Keenan Wants Two More Fosamax - ONJ Bellwether Cases To Go To Jury Verdict After This Trial(Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: "Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX(R) (alendronate sodium)" (10/3/11, Merck Press Release)_____________________________________________________________________ UPDATE: On August 30, 2011… [read post]
19 Aug 2011, 1:55 pm
New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon (Posted by Tom Lamb at DrugInjuryWatch.com)This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects. [read post]
12 Aug 2011, 12:44 pm
., Yet (Posted by Tom Lamb at DrugInjuryWatch.com)On August 4, 2011 Health Canada issued this Information Update, "Finasteride (Propecia, Proscar): Potential rare risk of breast cancer in men", which let us know about a possible new drug safety issue. [read post]
8 Aug 2011, 12:00 pm
About the Author: Tom Blackwell is a credentialed Medicare Set-Aside Consultant. [read post]
5 Aug 2011, 2:27 pm
European Drug Regulator EMA Recommended New Actos Contra-Indications And Warnings In July 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) On August 4, 2011 we learned that Takeda Pharmaceuticals America, Inc. had revised the prescribing information -- also called the package insert or label -- for its diabetes drug Actos (pioglitazone) and other anti-diabetic pioglitazone-containing medicines by means of this item, "FDA Drug Safety Communication: Updated drug labels for… [read post]
2 Aug 2011, 5:51 am
Let the civil justice system allocate any damages resulting from any wrongdoing that can be proved among all of the responsible parties, not just a few sacrificial lambs. [read post]
29 Jul 2011, 5:23 pm
Maine foreclosure defense attorney Tom Cox, the lawyer who uncovered the robo-signing at GMAC during a deposition last fall, had the following to say about Judge Grossman’s decision: “He (Judge Grossman) does the most thorough and competent analysis of the MERS charade that I have seen, basically concluding that the entire MERS business model does not comply with our laws, and that he will no longer accept MERS mortgage assignments in his court room. [read post]
29 Jul 2011, 2:32 pm
EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In recent months there has been a flurry of activity by drug safety regulators in North America as well as Europe concerning the progestin drospirenone and its apparent association with an increased risk of venous thromboembolism, e.g., pulmonary embolus, more commonly called pulmonary embolism, or pulmonary emboli (when… [read post]
22 Jul 2011, 2:34 pm
FDA Now Looking At Two-Fold Increase In CV Deaths, Strokes, And Heart Failure Hospitalizations From PALLAS Study Data (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Multaq (dronedarone) - Information on Increase in Heart-Related Events in Patients with Permanent Atrial Fibrillation - Sanofi-aventis Canada Inc. [read post]
19 Jul 2011, 1:32 pm
Liver Failure, Renal Impairment, And Cardiovascular Problems Cited As Potential Signals Of Risk Involving Multaq (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Health Canada announced on July 21, 2011 that it is reviewing the heart-related safety of Multaq. [read post]
12 Jul 2011, 2:13 pm
EMA And FDA Already Had Sanofi Issue A "Dear Doctor" Letter About Liver Failure In January 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA announced on July 21, 2011 that it is reviewing data from the PALLAS study which was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization… [read post]
5 Jul 2011, 10:35 am
Canadian Medical Journal Article Suggests That The June 2011 Label Change By FDA And Pfizer Is Not Sufficient Measure (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in mid-June 2011 the FDA issued these two items: Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events; and, FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular… [read post]
27 Jun 2011, 1:27 pm
New UK Study Found Three To Six Times Increased Risk Of Developing This Retinal Eye Disease Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com)A study presented at the American Diabetes Association’s annual meeting in San Diego on June 26, 2011 finds taking the diabetes treatments Actos (pioglitazone) and Avanidia (rosiglitazone) -- both in the Thiazolidinediones (TZDs) class of drugs -- have a three to six times increased risk of developing diabetic macular edema (DME),… [read post]
