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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
Label Changes About Side Effects For These Type 2 Diabetes Medicines In The Drug Class Called Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2015 the FDA announced that it has found indications of a new side effect for a class of diabetes drugs -- dipeptidyl peptidase-4 (DPP-4) inhibitors -- that includes Januvia, Onglyza, Tradjenta, and Nesina. The FDA found drug adverse event reports of arthralgia, or severe pain in one or more joints, associated with the use of DPP-4 inhibitor diabetes drugs, with Januvia being the one implicated most often, followed by Onglyza. According to the FDA, patients started having symptoms of the new side effect from one day to years after they started taking Januvia, Onglyza, Tradjenta, Nesina or one of the "combination" DPP-4 inhibitors, e.g., Janumet (sitagliptin and metformin). Further the FDA reported that after the DPP-4 inhibitor medicine was discontinued the patients' symptoms were relieved, usually in less than a month from stopping the subject drug. Furthermore, some patients developed severe joint pain again when they restarted the same medicine or another DPP-4 inhibitor. This last fact provides some substantiation for linking this severe joint pain side effect with Januvia, Onglyza, Tradjenta,... Continue reading
Posted 2 days ago at Drug Injury Watch
Quoted from http://www.reviewjournal.com/news/las-vegas/las-vegas-trial-centers-diabetes-drug-actos Las Vegas trial centers on diabetes drug Actos By Carri Geer Thevenot Las Vegas Review-Journal August 27, 2015 Billions of dollars are at stake in a Las Vegas trial that centers on two men who were diagnosed with bladder cancer after taking the diabetes drug Actos. "When it comes to our medicines, we have the right to know the truth, the whole truth and nothing but the truth," attorney Robert Eglet told jurors Thursday. "And that's what this case is about." Eglet represents Mary Iorio, the widow of Maurice Iorio, who once worked as a bailiff in... Continue reading
Thank you for this inquiry. The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States 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. 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'." It is possible that there could be some federal legislation forthcoming which would "fix" the current situation. Unfortunately, I have had to explain this unfair situation to many people who suffered a drug injury involving a generic drug since this ruling by the US Supreme Court in 2011. Tom Lamb
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As With Invokana and Farxiga, Jardiance Is Subject Of Several Drug Regulatory Agency Investigations About Ketoacidosis And Other Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) Jardiance is part of the Sodium-Glucose Co-Transporter-2 (SGLT-2) Inhibitors class of diabetes drugs, which also includes Invokana and Farxiga. These new SGLT-2 diabetes medications -- which are distinctive from other diabetes drugs insofar that they make the kidneys extract a significant amount of sugar from the blood to be excreted in urine -- are prescribed to treat Type-2 diabetes. Unfortunately, over the years Type 2 diabetes has become much more common, in part due to the so-called obesity epidemic here in the US. About 95 percent of the nearly 30 million American adults and children -- which is almost 10 percent of the current US population -- have Type 2 diabetes. And approximately 86 million more Americans have been diagnosed with "pre-diabetes", with most of those individuals likely to develop diabetes in the future. As such, the financial analysts who focus on the pharmaceutical sector were all abuzz earlier this week as regards an announcement about a new medical study concerning Jardiance. From an August 20, 2015 Forbes article, "Sweet Victory: Eli Lilly's Jardiance... Continue reading
Posted Aug 21, 2015 at Drug Injury Watch
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Quoted from http://www.forbes.com/sites/arleneweintraub/2015/08/17/abbvie-challenges-fairness-of-upcoming-testosterone-trials/ AbbVie Challenges Fairness Of Upcoming TestosteroneTrials August 17, 2015 Nearly 2,000 men who believed they suffered heart attacks and other adverse events after taking testosterone have sued seven of the hormone’s manufacturers, and now the court handling the consolidated lawsuits has picked one of those companies to go on trial first: AbbVie, maker of the popular AndroGel. Six so-called bellwether trials will begin in October 2016, and lawyers representing AbbVie and the men who have sued the company have been instructed to pick 32 representative cases for potential trial over the next few months. The selection of... Continue reading
Like Eliquis, Xarelto, And Pradaxa, This New Blood-Thinner Is Being Sold By Drug Companies At A Time When Profits May Be Taking Priority Over Patient Safety (Posted by Tom Lamb at DrugInjuryWatch.com) Savaysa (edoxaban) is from the drug company Daiichi Sankyo, Inc. Savaysa is the fourth new oral anticoagulant (NOAC) that has been brought to the US market in recent years before any so-called "antidote" was approved by FDA -- like Pradaxa, Xarelto, and Eliquis. In a January 2015 FDA News Release that significant drug-safety issue was acknowledged. From this item, "FDA approves anti-clotting drug Savaysa", we get the following relevant information: The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.... The most common side effects observed in clinical trial participants were bleeding and anemia. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anti-coagulant effect of Savaysa... [emphasis added] We have written several articles over the past year about... Continue reading
Posted Aug 13, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/08/08/eli-lilly-cymbalta-trial-idUSL3N10J00J20150808 U.S. jury clears Eli Lilly in first Cymbalta withdrawal trial August 7, 2015 Eli Lilly on Friday was cleared of liability in the first trial involving claims that its antidepressant Cymbalta caused severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations, the company said. Eli Lily has been sued by roughly 250 plaintiffs who say that the company downplayed warnings about symptoms that can occur when patients quit the popular drug, which has annual sales of about $3.9 billion. The trial this week on the lawsuit filed by Claudia Herrera in federal court in California is... Continue reading
These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________ UPDATE: "Novartis AG (NVS) Reports Third Case of PML in Relapsing MS Patient Treated with Gilenya" (8/18/15, BioSpace) (8/18/15) ________________________________ On August 4, 2015 the FDA posted on its web site this Safety Alert, "Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection", from which we get this basic information: ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label. BACKGROUND: Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce... Continue reading
Posted Aug 6, 2015 at Drug Injury Watch
Since Bayer Revised YAZ Label In April 2012 There Has Been More Medical Evidence That DRSP Pills Increase Risks Of Blood Clot Side Effects Like DVT And PE (Posted by Tom Lamb at DrugInjuryWatch.com) The drug labels for Yasmin, YAZ, Safyral, and Beyaz were revised by Bayer and the FDA in April 2012 by adding information about the several different (in terms of their conclusions) medical studies concerning the increased blood clot risks associated with drospirenone-containing birth control pills. For more details about this April 2012 drospirenone (DRSP) label revision announcement by the FDA, see: "FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone". From that FDA document we get this summary of that April 2012 Bayer YAZ label change: The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an... Continue reading
Posted Jul 29, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/07/24/products-cymbalta-mdl-idUSL1N10425Z20150724 Cymbalta plaintiffs make second bid for MDL By Jessica Dye July 24, 2015 More than 40 plaintiffs are asking a federal judicial panel to reconsider a request to consolidate lawsuits accusing Eli Lilly & Co of failing to warn patients about the side effects they could suffer if they stop taking its antidepressant Cymbalta. On Thursday, attorney Steven Stein of Knox Ricksen urged the U.S. Judicial Panel on Multidistrict Litigation to grant the motion, saying that the number of plaintiffs and law firms involved in the litigation has grown significantly, and efforts to informally coordinate the cases... Continue reading
April 2015 FDA Advisory Committee Voted For An Onglyza Drug Label Change About Side Effects Risks, With One Panelist Voting Of An Onglyza Recall (Posted by Tom Lamb at DrugInjuryWatch.com) As previewed in our March 2015 article, "Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting", the results of Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) were discussed recently by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee. For those who want to get in-depth on this emerging drug safety issue concerning Onglyza and Kombiglyze XR, you can read the "Briefing Information for the April 14, 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)". In the alternative, for the so-called "bottom line" as regards this recent Onglyza FDA Advisory Committee meeting, you can look at the "Minutes for the April 14, 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)", from which we get this information: VOTE: Which action do you recommend FDA take regarding the totality of the safety information (Cardiovascular and other)... Continue reading
Posted Jul 23, 2015 at Drug Injury Watch
Here is my most recent article about the Fosamax litigation, from June 2015: Fosamax – Femur Fracture Lawsuits Update: California Verdict For Merck In April 2015 With Two More California Trials Scheduled For July 2015 And October 2015 http://www.druginjurylaw.com/2015/06/18/fosamax-femur-fracture-lawsuits-update-california-verdict-for-merck-in-april-2015-with-two-more-california-trials-scheduled-for-july-2015-and-october-2015/ Let me know if you have any questions. Tom Lamb
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This is my latest report, from June 18, 2015: Fosamax – Femur Fracture Lawsuits Update: California Verdict For Merck In April 2015 With Two More California Trials Scheduled For July 2015 And October 2015 http://www.druginjurylaw.com/2015/06/18/fosamax-femur-fracture-lawsuits-update-california-verdict-for-merck-in-april-2015-with-two-more-california-trials-scheduled-for-july-2015-and-october-2015/ Let me know if you have any questions. Tom Lamb
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And It Is Possible That Generic Zofran / Ondansetron - Birth Defects Cases Might Be Filed In California And Some Other State Courts (Posted by Tom Lamb at DrugInjuryWatch.com) On July 6, 2015 the drug company GlaxoSmithKline (GSK) filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that a multidistrict litigation (MDL) be established for all Zofran lawsuits filed in the federal court system concerning Zofran's alleged association with birth defects. From their legal document "BRIEF IN SUPPORT OF DEFENDANT GLAXOSMITHKLINE LLC’S MOTION FOR TRANSFER OF ACTIONS PURSUANT TO 28 U.S.C. § 1407": Plaintiffs contend that their minor children suffered birth defects following the mothers’ ingestion of Zofran® prescribed for treatment of severe morning sickness during pregnancy (a condition that can threaten the health of mother and baby). Plaintiffs all claim that the drug they allegedly ingested was defectively designed, manufactured, and/or marketed by GSK, resulting in serious physical injuries to their children, and that GSK failed to provide adequate warnings of the risks and dangers posed by Zofran®. Plaintiffs also allege that GSK improperly marketed Zofran® “off-label” to doctors for treating morning sickness during pregnancy without FDA approval. According to this same legal document, as... Continue reading
Posted Jul 17, 2015 at Drug Injury Watch
Drug Injury Lawyers Also See Possible Farxiga And Jardiance Cases For Patients Who Have Ketoacidosis, Kidney Failure, Stroke, Or Heart Attack (Posted by Tom Lamb at DrugInjuryWatch.com) With there being a growing number of Type 2 diabetes patients in the US, it is not a surprise that the pharmaceutical companies are introducing new types of diabetes medications at an increasing rate to capture market share and make profits. One new class of new diabetes medications are Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, which currently consist of these drugs: Invokana (canagliflozin) -- first available in 2013 Invokamet (canagliflozin and metformin) -- first available in 2014 Farxiga (dapagliflozin) -- first available in 2014 Xigduo XR (dapagliflozin and metformin extended-release) -- first available in 2014 Jardiance (empagliflozin) -- first available in 2014 Glyxambi (empagliflozin and linagliptin) -- first available in 2015 As some of you know, often the serious side effects of new drugs are not recognized until after FDA approval and they are used by a larger patient population than was observed or studied in the earlier clinical trials. And this seems to be the case with Invokana, Farxiga, Jardiance, and these other new diabetes drugs, as there are now numerous adverse event report... Continue reading
Posted Jul 2, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/07/01/products-levaquin-ruling-idUSL1N0ZH2QA20150701 9th Circuit revives suit linking Levaquin to deadly skin disease By Jessica Dye July 1, 2015 A federal appeals court has reinstated a woman's claim alleging that Levaquin, an antibiotic made by Johnson & Johnson's Janssen Pharmaceuticals unit, caused a life-threatening skin condition that put her in a coma for two weeks. On Tuesday, the 9th U.S. Circuit Court of Appeals said that the district court had been too hasty in concluding that Gail Holmes' strict products liability claim was barred by California's two-year statute of limitations, since she was still in a coma on the day... Continue reading
Institute For Safe Medication Practices Signal For Invokana Kidney Failure Risks Seems To Apply To Farxiga, Jardiance, And Other SGLT2 Diabetes Drugs Also (Posted by Tom Lamb at DrugInjuryWatch.com) On May 15, 2015 the FDA announced it is investigating a association between Farxiga, Jardiance, and Invokana with diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. See: "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood". About a month later, Health Canada took similar action when that drug regulatory agency sent an email alert about its "Information Update - Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis". From that June 22, 2015 Health Canada MedEffect email alert we get this: Health Canada initiated a safety review for the prescription diabetes drugs [Forxiga / Farxiga (dapagliflozin)] and [Invokana (canagliflozin)] and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones. [Forxiga / Farxiga (dapagliflozin)] and [Invokana (canagliflozin)] are known as SGLT2 (sodium-glucose cotransporter-2) inhibitors and are approved in Canada for use in patients with type 2 diabetes to improve blood sugar levels,... Continue reading
Posted Jun 25, 2015 at Drug Injury Watch
Now About Six Years Out From When This Beyaz / Safyral / YAZ / Yasmin / Gianvi / Ocella Drug Injury Litigation Started, Bayer Continues Its Slow-Going Pace (Posted by Tom Lamb at DrugInjuryWatch.com) To put into context the latest YAZ / Yasmin lawsuits and settlement numbers from Bayer, we start by referring back to this earlier article, "YAZ / Yasmin Litigation Update For March 2015: According To Bayer's 2014 Annual Report, 'Additional lawsuits are anticipated.'", where we get this corporate filing information: As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled). As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion. At present, about 2,000 such claims are under review.... _____________________________________________________ Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi Free Case Evaluation Strictly Confidential, No Obligation. _____________________________________________________ The most recent Bayer information about the YAZ / Yasmin litigation comes from the Bayer Interim Report for First Quarter of 2015 (at pg. 46 of PDF): Yasmin™/yaz™: As of April 20, 2015,... Continue reading
Posted Jun 22, 2015 at Drug Injury Watch
These drug injury lawsuits involve any form of brand name Fosamax -- as well as Actonel, Boniva, and Reclast -- but NOT the generic equivalent of Fosamax, alendronate, nor the generic version of any other bisphosphonates. Of course, any medical questions should be directed to your mother's doctor. Tom Lamb
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Federal Court Fosamax MDL Reassigned From Judge Pisano To Judge Wolfson While We Wait For Appellate Court To Rule On Appeals From Glynn And Gaynor Case Rulings (Posted by Tom Lamb at DrugInjuryWatch.com) ********** UPDATE: "Remaining Fosamax Cases Dismissed But Not Dead" (New Jersey Law Journal, 6/23/15) U.S. District Judge Freda Wolfson of the District of New Jersey has dismissed the last remaining 570 cases in the Fosamax - femur fracture federal court MDL, but the cases could be reinstated if plaintiffs win an appeal currently pending before the U.S. Court of Appeals for the Third Circuit. (6/24/15) ********** Since we last reported on the Fosamax - femur fracture litigation there has been a trial verdict in a California state court case and in early April 2015 the jury sided with the defendant drug company Merck, i.e., defense verdict. This lawsuit was Galper v. Merck, and the trial stated in February 2015. Unless things have changed recently, the next California state court Fosamax lawsuit trial is scheduled to start in July 2015, with one to follow in October 2015. Of course, the results of those California femur fracture trials are much anticipated. Meanwhile, in the federal court Fosamax MDL pending... Continue reading
Posted Jun 17, 2015 at Drug Injury Watch
This Ketoacidosis Side Effect For These New Diabetes Medicines Was The Subject Of A May 2015 FDA Drug Safety Warning Which Was, Perhaps, Not Strong Enough About Dangers (Posted by Tom Lamb at DrugInjuryWatch.com) We reported about the recent "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood", issued on May 15, 2012, in this article: "May 2015 Diabetes Drugs - Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible". Diabetic ketoacidosis (DKA) is a relatively rare medical condition with blood glucose of 250 mg/dL or higher with ketonuria, ketonemia, and metabolic acidosis (pH < 7.3 or blood bicarbonate levels < 15 mEq/L). While DKA generally occurs in patients with type-1 diabetes it may occur, also, in patients with type-2 diabetes under stress conditions such as trauma, certain medical events, infection, or prescription drugs -- such as Invokana, Farxiga, and Jardiance, according to the FDA. At the June 2015 American Diabetes Association 2015 Scientific Sessions in Boston the findings of a new medical study about the significance of repeat incidents of diabetic ketoacidosis (DKA) as regards mortality rate were presented... Continue reading
Posted Jun 10, 2015 at Drug Injury Watch
In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? (Posted by Tom Lamb at DrugInjuryWatch.com) Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a multiple myeloma drug. In more detail, from the Celgene Corporation Prescribing information for Pomalyst (accessed 6/3/15): POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. ________________________________ Pomalyst Case Evaluation Strictly Confidential, No Obligation. ________________________________ On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, "Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity", which stated: A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports. This May 2015 MHRA Drug Safety Update included this detailed information about each of these Pomalyst side effects: Cardiac... Continue reading
Posted Jun 3, 2015 at Drug Injury Watch
New Medical Journal Article Presents "Compelling Evidence" That These Newer Oral Contraceptives Are Associated With More Venous Thromboembolism Events (Posted by Tom Lamb at DrugInjuryWatch.com) Beyaz, Safyral, YAZ, and Yasmin are birth control pills which contain ethinyl estradiol (EE) and the progestin drospirenone (DRSP). These DRSP oral contraceptives have been associated with several different adverse side effects such as: Blood Clots Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Stroke or Cerebrovascular Accidents (CVA) Heart Attack or Myocardial Infarction From an Editorial piece published May 26, 2015 by the medical journal BMJ, "Fresh evidence confirms links between newer contraceptive pills and higher risk of venous thromboembolism", we get this commentary from Susan S. Jick (a professor of epidemiology at Boston Collaborative Drug Surveillance Program, Boston University School of Public Health): Notably, Vinogradova and colleagues also looked at the newer oral contraceptives, such as those containing desogestrel, gestodene, and cyproterone, as well as the newest pill containing drospirenone, where data have been limited and the magnitude of effects on the risks of venous thromboembolism remains controversial. They found that the newer contraceptives increased risks by around 3.6- to 4.3-fold compared with non-use, and by around twofold compared with oral contraceptives containing levonorgestrel,... Continue reading
Posted May 27, 2015 at Drug Injury Watch
Case Reports Of These Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Causing Diabetic Ketoacidosis (DKA) Presented At Recent Medical Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA is investigating a connection between a certain class of diabetes medicines and diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. From "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood", issued on May 15, 2015: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines [Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin)] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.... A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA),... Continue reading
Posted May 20, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/05/15/fda-diabetes-idUSL1N0Y615520150515 U.S. FDA warns on newer class of type 2 diabetes drugs By Bill Berkrot May 15, 2015 May 15 (Reuters) - The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization. The oral drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana... Continue reading