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Tom Lamb
Wilmington, NC, USA
Tom Lamb is a lawyer who represents patients and their family in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Most Of These Patients Did Not Experience Any Kidney Or Renal Problems Before Developing CKD Linked To PPI Heartburn Drugs Or Reflux Medicines (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical study done by medical researchers in St. Louis, Missouri adds to the growing body of evidence which indicates that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause serious kidney-related side effects, including these conditions: Acute Interstitial Nephritis (AIN) Chronic Kidney Disease (CKD) End-Stage Renal Disease (ESRD) Severe Renal Impairment Kidney / Renal Failure Acute Kidney Injury This newest study indicates that more than half of those patients who develop chronic kidney damage (CKD) while using proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines do not experience acute kidney problems before their CKD diagnosis. These researchers at Washington University School of Medicine in St. Louis and the Veterans Affairs St. Louis Health Care System published their findings in this February 2107 article, "Long-term kidney outcomes among users of proton pump inhibitors without intervening acute kidney injury", published in the Kidney International medical journal. ___________________________________________ Nexium / Prevacid / Prilosec Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________ A February 22,... Continue reading
Posted 5 days ago at Drug Injury Watch
Drug Safety Regulators Flag An Increased Risk Of Hepatitis B Virus Reactivation Which Can Result In Cases Of Fulminant Hepatitis, Liver Failure, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) In February 2017 a so-called "black-box" warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases of hepatitis B virus (HBV) reactivation have been reported. Further, it states that some of those cases resulted in fulminant hepatitis, hepatic failure, and death. You can view the Prescribing Information for Sovaldi (accessed 2/16/17) to see how this new black-box, or bolded, warning appears on the drug label. For more details, we get the following from the Warnings and Precautions part of the February 2017 revised Sovaldi drug label: 5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients... Continue reading
Posted Feb 16, 2017 at Drug Injury Watch
The EMA released a statement that it will be reviewing the safety of pulmonary arterial hypertension drug, Uptravi, after five patients in France died. Continue reading
Posted Feb 15, 2017 at Drug Safety Developments
The EMA recently released study findings concerning the link between diabetes drugs Invokana / Invokamet and an increased risk of lower-limb amputations. Continue reading
Posted Feb 10, 2017 at Drug Safety Developments
For Eliquis Cases Filed In California State Court, JCCP Case Coordination Petition Is Still Pending, With Determination Expected In Next Couple Of Months (Posted by Tom Lamb at DrugInjuryWatch.com) The Eliquis drug injury litigation is still at its beginning stages, with less than 100 lawsuits across the country having been filed to date. Eliquis (apixaban) was approved by the FDA in 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis. Eliquis does not have an antidote for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. These medical conditions may have been caused by the use of Eliquis: • Serious Bleeding Events • Irreversible Fatal Bleeding Events • Trauma-induced Atypical Bleeding Incidents • Gastrointestinal (GI) Bleeds • Rectal Bleeding • Hemorrhages • Brain Hemorrhage • Intracranial Hemorrhage • Hemorrhagic Stroke • Cardiac Bleeds During the past year or so, an increasing number of Eliquis lawsuits have been filed involving people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis. In the federal court system, there are now more than 50 Eliquis lawsuits filed, and more of these drug injury and death cases are expected. Given this situation, in... Continue reading
Posted Feb 10, 2017 at Drug Injury Watch
Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera (dimethyl fumarate) was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS). In February 2016 a rare but potentially fatal neurological disorder, progressive multifocal leukoencephalopathy (PML), was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera. A more recent major change came in January 2017, with this one adding liver injury to the Warnings and Precautions part, as seen in the current Tecfidera drug label (accessed 2/7/17): 5.4 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver... Continue reading
Posted Feb 7, 2017 at Drug Injury Watch
The safety of newer hepatitis C treatment drugs is being called into question due to liver damage and Hepatitis B reactivation among users of these drugs. Continue reading
Posted Jan 30, 2017 at Drug Safety Developments
January 2017 ISMP Report: FDA Database Has 524 Cases Of Liver Failure, Including 165 Deaths, And 1,058 Reports Of Severe Liver Injury (Posted by Tom Lamb at DrugInjuryWatch.com) A January 24, 2017 article published by The New York Times, "Are New Drugs for Hepatitis C Safe? A Report Raises Concerns", sets the stage for and captures the essence of this emerging drug safety issue for a relatively new class of drugs: The drugs covered in the new report include two blockbusters, Sovaldi and Harvoni, both made by Gilead Sciences and priced at $1,000 a pill, with billions of dollars in sales. Sovaldi was approved in 2013, and Harvoni in 2014. These drugs and other antivirals can cure the disease in 12 weeks in many patients. Earlier drugs were less effective, had to be taken for much longer and had harsh side effects that left many patients unable to finish the course of therapy. About 250,000 people took the newer drugs in 2015, the report said, at tremendous expense: $55,000 to $125,000 per patient. In those treated during the year ending June 30, 2016, the report identified 524 with liver failure, 165 of whom died. Of those with liver failure, 386... Continue reading
Posted Jan 27, 2017 at Drug Injury Watch
After women in France who took Depakine gave birth to infants with birth defects, they started a class-action lawsuit against drug manufacturer, Sanofi. Continue reading
Posted Jan 26, 2017 at Drug Safety Developments
Black-Box Warning Now Includes Venous Thromboembolism As Well As Various Types Of Arterial Occlusions, And There Are More New Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) Iclusig (ponatinib) is a kinase inhibitor approved by the FDA as a treatment for certain types of leukemia in adult patients. On November 28, 2016 we learned about several alerting and wide-ranging safety labeling changes for Iclusig which were recently approved by the FDA Center for Drug Evaluation and Research (CDER). The complete set of new side effects warnings can be seen on the FDA's Drug Safety Labeling Changes (SLC) page for Iclusig. __________________________________________________________________ Iclusig Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________________________________ Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA. In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. Also, there is a new part entitled Venous Thromboembolism which addresses venous occlusive events. Under the Warnings and Precautions section of the Iclusig drug label there were some additional facts and new information put in the following... Continue reading
Posted Jan 19, 2017 at Drug Injury Watch
James: Yes, as we discussed on the phone earlier this afternoon, we are interested in your Viagra / Cialis case and look forwarding to learning about it by means of the Questionnaire which we have sent to you by email. Here is a link to the information page of the Melanoma Drug Injury litigation: http://www.druginjurylaw.com/viagra-levitra-cialis-revatio-sildenafil-melanoma-skin-cancer-side-effects-warning/ We look forward to working on your behalf. Tom Lamb
1 reply
Conflicting Findings From Different Medical Studies Leave The Extent Of This Drug Safety Issue Uncertain At Present Time (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: "New Safety Issue: Direct-Acting Antivirals Drugs For Hepatitis C Such As Harvoni And Sovaldi Could Cause Liver Failure" (1/30/17) Back in April 2016 we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation". As regards the liver cancer risks that have been mentioned in connection with the hepatitis C drugs Sovaldi and Harvoni, during the nine months since our earlier article, there have mixed messages about whether there is an apparent side-effect situation or not. We start our update on this still emerging drug safety issue with this April 2016 Medscape news report, "Liver Cancer Found in Hepatitis C Patients on New Antivirals", from which we get this excerpt: In a surprising number of patients with hepatitis C and cirrhosis, hepatocellular carcinoma develops within weeks of starting treatment with direct-acting antivirals, new research suggests. "I do not think that direct-acting antivirals are directly responsible," said lead investigator Stefano Brillanti, MD, from the University of Bologna, Italy. "The hypothesis is that immune... Continue reading
Posted Jan 11, 2017 at Drug Injury Watch
This December 2016 Label Change Mandated By Health Canada, However, Does Not Apply To Jardiance, Farxiga, And The Rest Of SGLT2 Inhibitors Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) From the Health Product InfoWatch newsletter -- formerly The Canadian Adverse Reaction Newsletter (CARN) -- put out by Health Canada in December 2016, under the "Product monograph updates" heading, we get this drug safety development: Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride) The risk of lower limb amputation, primarily of the toe, has been added to the Adverse Reactions section of the Canadian product monographs for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride). Key messages for healthcare professionals: In an ongoing cardiovascular study† of 4 327 patients with type 2 diabetes, with known or at high risk for cardiovascular disease, the incidence rates of lower limb amputation, primarily of the toe, were 7.3, 5.4 and 3.0 per 1 000 patient years of exposure to canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, with the imbalance occurring as early as the first 26 weeks of therapy. In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetes population of 8 111 patients, no difference in... Continue reading
Posted Jan 2, 2017 at Drug Injury Watch
Despite previous FDA label changes in 2012 for Yasmin, Yaz, Ocella, & Givanvi, there are still many reported cases of harmful side effects. Continue reading
Posted Dec 19, 2016 at Drug Safety Developments
Description of the harmful side effects that can result from using Yaz, Yasmin, Beyaz, Gianvi, Ocella, or Safyral birth control pills, which contain DRSP. Continue reading
Posted Dec 16, 2016 at Drug Safety Developments
December 2016 FDA Determination About Cardiovascular Benefits Also Includes Increased Drug Safety Warnings Label Change For Jardiance (Posted by Tom Lamb at DrugInjuryWatch.com) After the December 2, 2016 decision by the FDA to expand the health benefits for the relatively new diabetes medicine Jardiance (empagliflozin) to include preventing fatal heart attacks and strokes in type 2 diabetes patients, we saw news reports about its expected effect on Jardiance sales in the U.S. From this December 9, 2016 Reuters article, "New diabetes guidelines imminent, Jardiance sales may surge", we get this information: Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly's Jardiance in a move expected to drive up the drug's sales. The forthcoming guidelines from the American Diabetes Association and the American Association of Clinical Endocrinologists.... Ashtyn Evans, analyst with the Edward Jones investment company, expects annual Jardiance sales to approach $4 billion by the early 2020s, up from $200 million now, split with privately held German partner Boehringer Ingelheim. Evans predicted that doctors would now favor Jardiance for new patients over other similar drugs called SGLT-2 inhibitors, including Johnson & Johnson's Invokana and... Continue reading
Posted Dec 15, 2016 at Drug Injury Watch
The Proton Pump Inhibitors (PPIs) Class Of Drugs Has Long Been Associated With Some Serious Kidney-Related Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) There has long been medical evidence -- albeit little known by many until the past year -- that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause some serious kidney-related side effects including the following: Acute Interstitial Nephritis (AIN) Chronic Kidney Disease (CKD) End-Stage Renal Disease (ESRD) Severe Renal Impairment Kidney / Renal Failure Acute Kidney Injury In November 2016 we learned about a new study that suggests these popular category heartburn medications, known as proton pump inhibitors (PPIs), may increase the risk of ischemic strokes. ___________________________________________ Nexium / Prevacid / Prilosec Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________ From a press release from the American Heart Association, "Popular heartburn medication may increase ischemic stroke risk", we get the following facts: A popular group of antacids known as proton pump inhibitors, or PPIs, used to reduce stomach acid and treat heartburn may increase the risk of ischemic stroke, according to preliminary research presented at the American Heart Association’s Scientific Sessions 2016. “PPIs have been associated with unhealthy vascular function,... Continue reading
Posted Dec 5, 2016 at Drug Injury Watch
Again, thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. I wish you the best in all aspects going forward. Tom Lamb
1 reply
Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. I wish you the best in all aspects going forward. Tom Lamb
1 reply
Yaz was approved to treat PMDD before it was formally considered a distinct psychiatric condition. This increased profits and the drug's potential market. Continue reading
Posted Nov 18, 2016 at Drug Safety Developments
Recently, lawsuits have been brought against Sanofi and AbbVie / Abbott Labs for failing to warn about the possible negative side effects of Depakote. Continue reading
Posted Nov 14, 2016 at Drug Safety Developments
There in an ongoing debate amongst medical professionals concerning the effectiveness and safety of warfarin versus Eliquis, Xarelto, Savaysa, and Pradaxa Continue reading
Posted Nov 9, 2016 at Drug Safety Developments
Filed In October 2016, Defendants' MDL Motion Requests 34 Eliquis Cases Be Transferred To U.S. District Judge Lewis A. Kaplan In Southern District Of New York (Posted by Tom Lamb at DrugInjuryWatch.com) On October 13, 2016 attorneys for Bristol-Myers Squibb Company and Pfizer Inc. filed with the United States Judicial Panel on Multidistrict Litigation (JPML) this court document, "BRISTOL-MYERS SQUIBB COMPANY AND PFIZER INC.’S MOTION FOR TRANSFER OF RELATED ELIQUIS (APIXABAN) PRODUCTS LIABILITY ACTIONS FOR COORDINATED PRETRIAL PROCEEDINGS PURSUANT TO 28 U.S.C. § 1407, which will refer to as "Defendants' MDL Motion" hereafter. As for why these two drug companies think that Eliquis lawsuits filed in the federal court system should be consolidated as a Multidistrict Litigation (MDL) case, we get these contentions from the aforementioned Defendants' MDL Motion: Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively, “Defendants”)... bring this Motion.... In support of this Motion, BMS and Pfizer state as follows: 1. To date, there are 34 pending products liability actions filed against BMS and Pfizer in 13 different federal districts, alleging that the Plaintiffs were injured as the result of bleeding or a bleeding-related incident after taking Eliquis (also known by its molecular name apixaban), an anticoagulant... Continue reading
Posted Nov 9, 2016 at Drug Injury Watch
Essure can have serious side effects such as perforation, migration, and chronic pain. Here's what the FDA, Health Canada, and Bayer are doing about it. Continue reading
Posted Nov 2, 2016 at Drug Safety Developments
The Prescribing Information For Eliquis Suggests Such Use Is Safe, But There Is Limited Clinical Study Data In Support (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________ UPDATE: Here are two new medical journal articles published in the November 7, 2016 edition of Clinical Journal of the American Society of Nephrology: Use of Oral Anticoagulation in the Management of Atrial Fibrillation in Patients with ESRD: Pro Use of Oral Anticoagulation in the Management of Atrial Fibrillation in Patients with ESRD: Con (11/8/16) _________________________________________ Pradaxa (dabigatran), Xarelto (rivaroxaban), Savaysa (edoxaban), and Eliquis (apixaban) are often referred to generally as novel oral anticoagulants (NOACs). This new class of blood-thinner drugs offers an alternative to Coumadin or warfarin for patients who do not want required frequent INR monitoring, strict dietary restrictions, and problematic drug-drug interactions. In an August 2016 article, "Is Apixaban Safe and Effective for Patients on Hemodialysis?", Brandon Dyson, PharmD, BCPS, who is a clinical pharmacist at an academic medical center, puts some scrutiny on Eliquis, in particular: NOACs are a good fit for many patients, but there are limitations. For instance, many NOACs have a higher bleeding risk than warfarin in certain settings, and except for dabigatran, no reversal agent is... Continue reading
Posted Nov 1, 2016 at Drug Injury Watch