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29 Nov 2007, 2:29 pm
Some Panel Members Want Serevent Withdrawn From Market; FDA And GSK Say Asthma Drug Recall Is Not Appropriate (Posted by Tom Lamb at DrugInjuryWatch.com) On November 28, 2007 an FDA pediatric advisory panel recommended that the safety warnings on Serevent and Advair needed to be strengthened in order to emphasize the increased risk of hospitalization and death for children using these two asthma drugs from GlaxoSmithKline PLC (GSK). [read post]
6 Oct 2009, 1:23 pm
Emerging Safety Issues Concerning FDA-Regulated Products Is One Issue For Discussion Listed in October 2009 Federal Register Notice (Posted by Tom Lamb at DrugInjuryWatch.com) In the Federal Register for October 5, 2009 the FDA gave notice about a second public meeting to discuss issues related to transparency at the agency to be held in Washington, DC on November 3, 2009. [read post]
29 Mar 2007, 7:00 pm
Safety Profile Of Natrecor Continues To Be Subject Of Controversy And Debate (Posted by Tom Lamb at DrugInjuryWatch.com) The results of a large study for Johnson & Johnson's heart failure drug Natrecor failed to prove that its out-patient use in people with severe disease in addition to the current standard treatment regimen was any more beneficial than the standard treatment alone. [read post]
9 Apr 2007, 7:30 am
Action Follows News Of Studies Which Revealed Link To Serious Heart Valve Damage (Posted by Tom Lamb at DrugInjuryWatch.com) On March 29, 2007 the FDA announced that Permax as well as two generic pergolide drug products, which had been used to treat Parkinson's disease, would be voluntarily removed from the U. [read post]
18 Dec 2008, 2:21 pm
This Diverse List Of 50 Medical-Related Blogs Covers Various Aspects, With An Emphasis On Medical Ethics (Posted by Tom Lamb at DrugInjuryWatch.com) On December 15, 2008 the USPharmD+ web site posted an article by Alisa Miller, "Top 50 Medical Ethics Blogs", which presents a list of various medical-related blogs, broken down by category and with a brief description of each blog. [read post]
18 Apr 2008, 6:11 am
Some Important Terms Are Defined And Various Research Resources From FDA Are Listed (Posted by Tom Lamb at DrugInjuryWatch.com) On April 11, 2008 the FDA added to its web site one page that gives short definitions for some important terms used in the realm of prescription drug safety, and another page that is intended to assist one when researching medication safety issues. [read post]
10 Jun 2008, 8:58 pm
June 2008 Drug Recall By ETHEX Is Similar To Digitek Recall, But Here The Drug Company Is Able To Provide Specific Information About Dates And Lot Numbers, Unlike Actavis (Posted by Tom Lamb at DrugInjuryWatch.com) A June 10, 2008 FDA MedWatch Email Alert had a familiar sound to those of us following the Digitek recall: "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness". [read post]
25 Jul 2008, 7:34 pm
Risk Of Adverse Hepatic Reactions, Including Fatal Liver Injury, Is Cited by European Regulators At July 2008 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMEA), concluded at its July 2008 meeting that the benefits of oral moxifloxacin medicines continued to outweigh the risks, but went on to state that these antibiotics should be… [read post]
13 May 2009, 12:25 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) On May 11, 2009 AS Medication Solutions, LLC -- which is a drug repackage company --announced that it has recalled all tablets of Caraco digoxin tablets because those pills may differ in size and therefore could have more or less of the active ingredient, digoxin. [read post]
4 Aug 2008, 8:05 pm
FDA Inspection "revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices" (Posted by Tom Lamb at DrugInjuryWatch.com) All of a sudden it seems that the sky is falling for some generic drug companies. [read post]
19 Feb 2009, 2:46 pm
European Union Regulators, On Same Day, Recommend That Raptiva Be Withdrawn Because Its Risks Outweigh The Benefits (Posted by Tom Lamb at DrugInjuryWatch.com) On February 19, 2009 the FDA confirmed that Raptiva (efalizumab) had been linked to three cases of progressive multifocal leukoencephalopathy (PML), a rare brain infection which causes swelling of the brain and is usually fatal. [read post]
1 Aug 2007, 5:20 am
Medication Non-Adherence In America Is A National Crisis Costing Billions Of Dollars According To An August 2007 Report (Posted by Tom Lamb at DrugInjuryWatch.com) Two July 30, 2007 articles by Lauran Neergaard, a reporter who covers health and medical issues for The Associated Press (AP), bring us some important information about prescription medication adherence, or the lack thereof, in the U.S. [read post]
20 Jul 2009, 2:00 pm
FDA And Health Canada Had Zelnorm Removed From Respective Markets In March 2007 Due To Concerns About Cardiovascular Safety (Posted by Tom Lamb at DrugInjuryWatch.com) In November 2008 a national class action was filed against Novartis Pharmaceuticals Canada Inc., seeking damages on behalf of all Canadians who ingested the medication Zelnorm (tegaserod) which was used by patients who had severe constipation or irritable bowel… [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]
16 Jun 2009, 2:17 pm
Two Reports From April 2009 Medical Journal Offer Possible Solutions To A Problem Which Affects At Least 1.5 Million People Per Year (Posted by Tom Lamb at DrugInjuryWatch.com) The April 27, 2009 edition of the Archives of Internal Medicine included two articles by researchers who have suggested some ways by which hospitals and pharmacists could work to reduce the high annual number of medication errors in the U.S. [read post]
23 Dec 2008, 8:57 pm
At Same Time, KV Pharmaceutical Suspends Shipments of All ETHEX Tablet-Form Drugs For An Indefinite Period (Posted by Tom Lamb at DrugInjuryWatch.com) On December 23, 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation. [read post]
12 May 2008, 8:59 am
North Carolina Board Of Pharmacy Has Posted A Copy Of The Bertek Digitek Drug Recall Notice On Its Web Site (Posted by Tom Lamb at DrugInjuryWatch.com) The home page of the North Carolina Board of Pharmacy (NCBOP) currently shows a May 5, 2008 news item about the Digitek recall which includes a link to this document, which they describe as the "recall notice": Urgent: Drug Recall -- Digitek ® (digoxin tablets, USP) Recall initiated by the… [read post]
25 Mar 2009, 12:17 pm
At Present, This March 2009 Recall Is Limited To Propafenone HCL 225 mg Tablets Shipped Between October 15, 2008 And November 26, 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a MedWatch Email Alert, on March 25, 2009 the FDA informed us about yet another quality control problem at a generic drug manufacturing facility. [read post]
18 Aug 2008, 9:24 pm
FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta (Posted by Tom Lamb at DrugInjuryWatch.com) On August 18, 2008 the FDA issued a MedWatch email alert regarding Byetta (exenatide) which informed us that the agency had received reports about six cases of hemorrhagic pancreatitis or necrotizing pancreatitis since October 2007. [read post]
2 May 2008, 6:22 am
Actavis Says They Have Received 11 Complaints About Digitek Side Effects That Date Back To 2006 (Posted by Tom Lamb at DrugInjuryWatch.com) The facts surrounding a late April 2008 recall of Digitek (digoxin) pills that may have twice the usual active ingredient are becoming less clear as we learn more in the days following the FDA's April 28 announcement. [read post]
