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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
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. 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 pre-existing parts, which are presented the order in which they... Continue reading
Posted 4 days ago 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) 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 surveillance may be reduced too rapidly," he told Medscape Medical News. "You have an immediate drop in viremia, but also... 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
One Unfortunate Fact These Two New Blood-Thinners Have In Common Is That Neither Has An FDA-Approved Antidote At Present Time (Posted by Tom Lamb at DrugInjuryWatch.com) Earlier this month the medical journal Chest published online (Epub ahead of print) this article, "Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation". Also earlier this month, JAMA Internal Medicine published online (Epub ahead of print) this article, "Stroke, bleeding, and mortality risks in elderly Medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation." In both of these medical study reports it seemed that Xarelto (rivaroxaban) was more likely to be involved in a serious bleeding event as an adverse reaction than was either Pradaxa (dabigatran) or Eliquis (apixaban). We previously touched upon the significance of these two new medical journal articles about a year ago with this post, "Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events -- Perhaps, But Neither Eliquis Nor Xarelto Have Any Specific Reversal Agent To Stop An Acute Bleed Once It Starts; Only Pradaxa Does". To set up this latest report on the safety controversy surrounding these non-vitamin K antagonist oral anticoagulants (NOACs),... Continue reading
Posted Oct 24, 2016 at Drug Injury Watch
There Is An Apparent Melanoma Skin Cancer Link For Each Of These ED Drugs Given How PDE5 Inhibition Augments Tumor Cell Invasiveness (Posted by Tom Lamb at DrugInjuryWatch.com) Viagra (sildenafil) was the first drug prescribed for male erectile dysfunction (ED) associated with an increased risk for malignant melanoma, starting back in 2014. In the past year there have been medical articles published suggesting that the four other brand name ED drugs which are phosphodiesterase 5 (PDE5) inhibitors -- Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil) -- are associated with an increased risk of melanoma skin cancer, too. Essentially, the active ingredients sildenafil, tadalafil, vardenafil, and avanafil which are found in these drugs act by inhibiting the phosphodiesterase 5 (PDE5). In turn, PDE5 inhibition augments tumor cell invasiveness, which promotes the development of malignant melanoma. As regards drug injury lawsuits concerning this melanoma side effect of ED drugs, that litigation began with Viagra cases being filed against Pfizer, the drug company responsible for Viagra. By April 2016 there was a sufficient federal court Viagra lawsuits filed that the Judicial Panel on Multidistrict Litigation (JPML) decided to create the so-called Viagra MDL, known fully as IN RE: VIAGRA (SILDENAFIL CITRATE)... Continue reading
Posted Oct 17, 2016 at Drug Injury Watch
While Mechanism And Frequency Currently Unknown, This Situation Can Involve Acute Hepatic Failure Or Fulminant Hepatitis Leading To Liver Transplantation Or Death (Posted by Tom Lamb at DrugInjuryWatch.com) Back in May 2016 Health Canada issued a safety warning, "BCR-ABL Tyrosine Kinase Inhibitors [GLEEVEC (imatinib mesylate), TASIGNA (nilotinib), BOSULIF (bosutinib), SPRYCEL (dasatinib), ICLUSIG (ponatinib hydrochloride)] - Risk of Hepatitis B Reactivation", which did not receive much public attention in the US. According to this May 4, 2016 Health Canada document, BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the treatment of specific types of blood cancers, including Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL), and less commonly, other types of cancers. The currently available medicines in this BCR-ABL TKIs class of drugs include: Gleevec (imatinib mesylate) -- Novartis Pharmaceuticals Canada Inc. Tasigna (nilotinib) -- Novartis Pharmaceuticals Canada Inc. Bosulif (bosutinib) -- Pfizer Canada Inc. Sprycel (dasatinib) -- Bristol-Myers Squibb Canada Iclusig (ponatinib hydrochloride) -- ARIAD Pharmaceuticals, Inc. Further, according to Health Canada, this apparent side effect of HBV reactivation in chronic HBV carriers is considered to be a class-effect of BCR-ABL TKIs. __________________________________________________________________ Gleevec / Iclusig Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________________________________ From... Continue reading
Posted Oct 10, 2016 at Drug Injury Watch
Thank you for your email inquiry. 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. Have a good week. Tom Lamb
1 reply
October 2016 FDA Drug Safety Communication Warns About These Relatively New Drugs Which Are Increasingly Popular For Treating Chronic Hepatitis C (Posted by Tom Lamb at DrugInjuryWatch.com) 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". Today, about six months later, the FDA indicated their concern for these relatively new chronic hepatitis C treatment drugs -- including Harvoni, Sovaldi, and Viekira Pak -- by issuing a Drug Safety Communication which started with this statement: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. As a result, FDA is requiring a Boxed Warning, our most prominent warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in... Continue reading
Posted Oct 4, 2016 at Drug Injury Watch
There has recently been a debate over what to call the class of drugs including Savaysa, Pradaxa, Xarelto, and Eliquis, which still do not have antidotes. Continue reading
Posted Sep 30, 2016 at Drug Safety Developments
I am glad to hear that your are motivated to take action as regards the unfair situations which are the results of how the federal preemption legal doctrine has been and still is applied to many drug injury cases, including yours. You can read a most unfortunate story involving this issue by going to this page: http://www.takejusticeback.com/KiraG. And here is some background about why the federal preemption doctrine has been applied to drug injury cases. The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims (see, in particular, pages 4–14 and 17–20 of this Pliva v. Mensing SCOTUS opinion). Here is a link to that opinion: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling. Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits: "As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome 'makes little sense'." Please know that your effort and time in connection with this matter are appreciated. Have a good day. Tom Lamb
1 reply
Thank you for your Comment. Unfortunately, this legal obstacle of "impossibility preemption" is being used increasingly by defense lawyers for pharmaceutical companies in drug injury litigation. Besides the Fosamax cases, it is a problem for the Byetta / Januvia / Victoza lawsuits, also. What we need are revised rule and regulations from the FDA and/or new legislation from our US Congress that would roll-back this federal preemption defense. I suggest that individuals contact their representatives in Washington, DC and bring this current legal problem to the attention of our lawmakers. Tom Lamb
1 reply
Use Of Prothrombin Complex Concentrates (PCC) Or Other Procoagulant Reversal Agents Have Not Been Evaluated In Clinical Outcome Studies (Posted by Tom Lamb at DrugInjuryWatch.com) In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.: Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information. And here is the "new" section 5.3 Risk of Bleeding part of the Savaysa Prescribing Information document (accessed 9/27/16) -- also known as the package insert or the drug label: Reversal of Anticoagulant Effect There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance [see Clinical Pharmacology (12.3)]. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant... Continue reading
Posted Sep 27, 2016 at Drug Injury Watch