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Tom Lamb
Wilmington, NC, USA
Tom Lamb is an attorney, or lawyer, who represents patients and their families in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Quoted from http://news.yahoo.com/biogen-profit-surges-tecfidera-sales-shy-street-view-120731126--finance.html Biogen's Tecfidera sales miss estimates; confirms first PML case By Bill Berkrot October 22, 2014 (Reuters) - Biogen Idec Inc said on Wednesday sales of its big-selling new multiple sclerosis drug Tecfidera fell short of Wall Street's lofty expectations, and the company confirmed a serious brain infection in a patient who took the oral medication, sending its shares 7 percent lower. Biogen reported the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera patient, who had been part of a clinical trial and was taking the drug for 4-1/2 years. The patient, who died of pneumonia,... Continue reading
I am sorry to hear about the recent loss of your uncle. Tom Lamb
1 reply
These Impulse Side Effects, As Seen In Adverse Drug Events Reports, Are Much Higher Than Previously Thought According To New Medical Journal Article (Posted by Tom Lamb at DrugInjuryWatch.com) Thomas Moore, A.B., a senior scientist at the Institute of Safe Medication Practices (ISMP), together with his fellow authors of a new medical journal article are calling for the addition of a so-called "black-box" warning to the drug labels for Mirapex, Requip, Neupro, and other medications used for Parkinson's disease and restless leg syndrome. Based on their findings about impulse control problems associated with these "dopamine agonists" drugs, they think there should be a heightened warning about unusual side effects in the form of compulsive behaviors involving gambling, shopping, and sex. This new medical journal article is "Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs", which was published online October 20, 2014 by the medical journal JAMA Internal Medicine. From an October 21, 2014 news report by HealthDay, "Parkinson's Drugs May Spur Compulsive Behaviors", we get this commentary and insight: Drugs commonly used to treat Parkinson's disease may raise the risk of so-called impulse control disorders, according to a new review. These disorders include compulsive... Continue reading
Posted yesterday at Drug Injury Watch
Thank you for sharing with us your unfortunate experience using YAZ. I am glad you are currently recovering from your side effect. As regards the legal situation here in the US as regards incidents like yours: At the present time Bayer is only negotiating cases where the date of injury or death was before April 2012, given the defense lawyers' position that a label change the drug company made that month distinguishes the "later" cases from the pre-April 2012 cases as regards their level of legal liability. Here is an article which I wrote about that label change: Drug Injury Watch: April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone (http://bit.ly/1sf5ViC) I wish you the best in all aspects going forward. Tom Lamb
1 reply
Cites Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects As Well As Increased Risk Of Autism Spectrum Disorder (Posted by Tom Lamb at DrugInjuryWatch.com) More restrictions of the use of valproate drugs -- such as Depakote, as well as Depakene and Depacon, from AbbVie Inc. (formerly Abbott) -- by women who may become pregnant have been recommended by a European drug regulatory committee. From an October 14, 2014 Medscape news report, "Restrict Valproate, EMA Committee Urges": The European Medicine Agency (EMA)'s Pharmacovigilance and Risk Assessment Committee has recommended strengthening the restrictions on the use of valproate in women of childbearing age. This is because of the risk for malformations and developmental problems in children exposed to valproate during pregnancy. The committee recommends that valproate not be used to treat epilepsy or bipolar disorder in girls and women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.... The recommendations of the committee will now be sent the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, which will adopt a final position. In the meantime, women currently taking valproate who have any questions about their treatment should... Continue reading
Posted Oct 14, 2014 at Drug Injury Watch
Quoted from http://www.pmlive.com/pharma_news/ema_safety_panel_rules_no_change_needed_for_ariads_iclusig_605906 EMA safety panel rules no change needed for Ariad's Iclusig Positive news comes after blood clot concerns The European Medicines Agency (EMA) has ruled the continued use of Ariad's cancer therapy Iclusig unchanged in the EU. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) brought an investigation into the safety of Iclusig (ponatinib) to a close late last week, concluding that there was no need to reduce the approved dose of the drug. Iclusig was approved in the US and EU last year for the treatment of adult patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute... Continue reading
And An Increased Risk Of Uveitis For Current "Repeat" Users Of Avelox Who Were On At Least Their Second Term Of Taking This Fluoroquinolone Antibiotic Pill (Posted by Tom Lamb at DrugInjuryWatch.com) The popular antibiotic Avelox (moxifloxacin) appears to significantly increase the risk for developing an eye disorder called uveitis, which is swelling and irritation of the uvea, the middle layer of the eye. This new finding comes from what seems to be the first epidemiologic study to examine the relationship between Avelox use and uveitis. The medical journal article reporting on this case-control study, "Risk for Uveitis With Oral Moxifloxacin: A Comparative Safety Study", was published online October 2, 2014 in the JAMA Ophthalmology medical journal. This new Avelox - uveitis study also found that Cipro (ciprofloxacin) was associated with a smaller increased risk of uveitis, but there was little to no increase for this particular eye-related side effect seen for Levaquin (levofloxacin). From an October 7, 2014 news report at Medscape.com, "Evidence Linking Some Fluoroquinolones to Uveitis Grows", we get get this summary of the recent Avelox study done by researchers at the University of British Columbia, Vancouver, British Columbia, Canada: "The results of the present study are... Continue reading
Posted Oct 8, 2014 at Drug Injury Watch
Quoted from http://www.al.com/news/birmingham/index.ssf/2014/10/alabama_federal_judge_settleme.html Alabama federal judge: Time to end nationwide litigation against Pfizer anti-smoking drug Chantix By Kent Faulk | kfaulk@al.com The Birmingham News October 06, 2014 FLORENCE, Alabama - All of the nearly 2,900 lawsuits claiming pharmaceutical giant Pfizer Inc.'s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled - for about $300 million - so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday. Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a... Continue reading
Quoted from http://www.bloomberg.com/news/2014-10-03/takeda-ordered-to-pay-more-than-2-million-to-ex-actos-user.html Takeda Ordered to Pay More Than $2 Million to Actos User By Jef Feeley and Christopher Yasiejko 2014-10-03 Takeda Pharmaceutical Co. was ordered by a jury to pay more than $2 million to a woman who claimed the company’s Actos diabetes medicine caused her bladder cancer, in the latest of thousands of lawsuits involving the drug to go to trial. Jurors in state court in Philadelphia deliberated more than five hours today before finding that officials of Osaka, Japan-based Takeda failed to properly warn Frances Wisniewski’s doctors about Actos’s cancer risk. The jury found Takeda “clearly failed... Continue reading
Quoted from http://www.bloomberg.com/news/2014-10-02/takeda-accused-in-trial-of-putting-actos-profits-ahead-of-safety.html Takeda Accused of Putting Actos Profit Ahead of Safety By Jef Feeley Oct 2, 2014 Takeda Pharmaceutical Co. was accused by a lawyer for a woman who blames Actos for her cancer of sacrificing safety for profit by failing to warn patients and doctors about the diabetes medicine’s risks. Executives at Osaka, Japan-based Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later to protect billions of dollars in sales of the drug... Wisniewski, a retired accountant who has bladder cancer, is the seventh Actos patient... Continue reading
Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2014 we learned more about serious side effects that have been linked to Xolair since this injectible drug for certain patients with asthma or chronic hives was approved in 2003. The drug companies responsible for Xolair are Genentech and Novartis Pharmaceuticals. From this document, "FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events", we get the latest news on this Xolair drug safety issue: A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain.... As a result, we have added information about these potential risks to the drug label.... Our review of a 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Xolair compared to those patients not treated with Xolair. The... Continue reading
Posted Oct 1, 2014 at Drug Injury Watch
Quoted from http://finance.yahoo.com/news/fda-says-asthma-drug-xolair-211402159.html FDA says asthma drug Xolair raises risk of heart, brain problems September 26, 2014 5:14 PM WASHINGTON, Sept 26 (Reuters) - The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday. The FDA said it has added information about the increased risk to the drug's label after analyzing findings from a five-year safety study submitted by the drug's manufacturer, Genentech, a unit of... Continue reading
August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy/Seizure, And Bipolar Medications Was Done Rather Quietly (Posted by Tom Lamb at DrugInjuryWatch.com) Without much notice, e.g., no FDA Drug Safety Communication was issued, in August 2014 the Prescribing Information, or drug labels, for Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) were updated by the drug company AbbVie Inc. (formerly Abbott) to add a warning about the potential risk for autism spectrum disorders (ASD). In the label approved by the FDA on August 20, 2014 for Depakote (accessed 9/25/14), this new warning about autism spectrum disorders can be found at Section 8.1 Pregnancy: An observational study has suggested that exposure to valproate products during pregnancy may increase the risk of autism spectrum disorders. In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk (95% confidence interval [CI]: 1.7-4.9) of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy. The absolute risks for autism spectrum disorders were 4.4% (95% CI: 2.6%-7.5%) in valproate-exposed children and 1.5% (95% CI: 1.5%-1.6%) in children not... Continue reading
Posted Sep 25, 2014 at Drug Injury Watch
Key Advisory Panel Member Concedes It Is Medically Plausible That Testosterone Replacement Therapy Can Be Associated With Heart Attacks / Strokes Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On September 17, 2014 members of the FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory panels considered the issue of whether the popular testosterone products Axiron, AndroGel, and Testim, as well as other so-called "Low-T" drugs, are safe. Not surprising -- but certainly unsettling -- was the outcome of their discussions, which was essentially that for most current users of testosterone replacement therapy (TRT) medications we do not know and cannot know, because no safety study has been done, yet. From a September 18, 2014 Healio EndocrineToday report, "FDA committees near-unanimous on need to investigate testosterone therapies": A key presentation by Shalender Bhasin, MD, of Harvard Medical School, with advisory board seats for two of the sponsors, broached the biggest topic of concern in the room during a presentation on cardiovascular events and testosterone therapies. “Testosterone’s effects in preclinical and clinical models are diverse,” Bhasin said. “Some effects are beneficial, and some may be potentially deleterious.” Bhasin conceded biologic plausibility for the association of testosterone with... Continue reading
Posted Sep 19, 2014 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2014/09/17/usa-health-testosterone-idUSL1N0RI2V820140917 FDA panel backs limiting use of testosterone replacement drugs Wed Sep 17, 2014 By Toni Clarke Sept 17 (Reuters) - Testosterone replacement therapies should be reserved for men with specific medical conditions that impair function of the testicles, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone. Prescriptions for "Low... Continue reading
Quoted from http://www.bloomberg.com/news/2014-09-16/possible-heart-risk-with-testosterone-spurs-debate-on-use.html Possible Heart Risk With Testosterone Spurs Debate on Use By Caroline Chen Sep 16, 2014 Testosterone supplements used last year by about 2.3 million men are spurring debates over how necessary and safe they may be, even as U.S. regulators consider approving a new product. Food and Drug Administration advisers tomorrow will consider whether the drugs are being prescribed to the right people. They also will weigh whether the labels should change to reflect heart risks suggested by some studies, according to FDA briefing documents. [Article continues at original source] Related articles Testosterone Products Like AndroGel /... Continue reading
Perhaps The Slow-Going Over Past Year Will Be Changed By Upcoming Mediations With Two Special Masters Appointed Recently By Judge Herndon (Posted by Tom Lamb at DrugInjuryWatch.com) In their Stockholders' Newsletter Financial Report as of June 30, 2014, Second Quarter of 2014 (PDF) Bayer informs at page 54 that as of July 2, 2014: Settlements with about 8,900 claimants for total of $1.8 billion; The number of pending claims with deep vein thrombosis (DVT) and/or pulmonary embolism (PE) -- the "venous clot injuries" -- is approximately 2400; and, There are an estimated 2,600 claims with other alleged drospirenone (DRSP) related injuries, such as arterial clots. Significant or not, in their latest quarterly report Bayer continues to only allude to YAZ, Yasmin, Ocella, and Gianvi cases -- while still making no mention of there being any Beyaz and Safyral cases filed (which there are, in fact). ______________________________________________________________________________ Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ So where do things stand in comparison to our last article about the Bayer DRSP birth control pills litigation? From just looking below at the title and sub-title of this June 2014 item we can see that more new blood clot cases have been filed... Continue reading
Posted Sep 12, 2014 at Drug Injury Watch
Hemorrhages And Gastrointestinal (GI) Bleeds Are Eliquis And Xarelto Side Effects That Can Cause Deaths (Posted by Tom Lamb at DrugInjuryWatch.com) Eliquis and Xarelto are new anticoagulants, i.e., blood thinners, that -- unlike Coumadin (warfarin) -- do not require regular INR monitoring and dose adjustments. Eliquis (apixaban) and Xarelto (rivaroxaban) are "factor Xa" drugs and they work differently from warfarin. These new blood thinners reduce thrombin production by inhibiting an enzyme called factor Xa instead of inhibiting vitamin K's clotting ability. A real danger or problem that Eliquis and Xarelto share with another new blood thinner drug, Pradaxa (dabigatran), however, is the absence of an approved drug that can reverse their effects. That is, at the present time there is no antidote to stop serious bleeding events. From a July 23, 2014 MedPage Today article, "Monitoring, Dose Adjustment for Pradaxa?", we get this important discussion about the safety issues surrounding Eliquis and Xarelto: While there's no extensive data published to prove it, variability in blood concentrations is likely for the other newer oral anticoagulants -- such as apixaban (Eliquis), rivaroxaban (Xarelto), and edoxaban (Savaysa) -- too, according to a letter from Boehringer employee Paul Reilly, PhD, and RE-LY study authors... Continue reading
Posted Sep 5, 2014 at Drug Injury Watch
Quoted from http://www.wral.com/fda-little-evidence-to-support-testosterone-drugs/13947227/ FDA: Little evidence to support testosterone drugs September 3, 2014 By MATTHEW PERRONE, AP Health Writer WASHINGTON — The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the male hormone. Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testosterone... Continue reading
State Superior Court Judge Nelson Johnson Now Presiding Over About 2880 Cases, According to Merck SEC Report Filed In August 2014 (Posted by Tom Lamb at DrugInjuryWatch.com) There is some news but not much to report about the New Jersey Multicounty Litigation where the Fosamax femur fracture lawsuits are centralized. Judge Carol Higbee, who was moved to a New Jersey appellate court position in the spring of 2014, has been replaced by the Honorable Nelson C. Johnson, of the New Jersey Superior Court in Atlantic County. According to the New Jersey Courts web site page for this Fosamax lawsuits consolidation, there were 3071 Fosamax cases filed as of August 23, 2014 (accessed 8/29/14). From that document alone one cannot determine how many of those lawsuits may be for cases alleging oseteonecrosis of the jaw (ONJ) as the Fosamax drug injury as opposed to atypical femur fracture events. However, we get an idea of the current number of Fosamax - femur fracture lawsuits filed in the New Jersey Multicounty Litigation from the Merck SEC Form 10-Q for the quarterly period ended June 30, 2014 (filed on or about 8/7/14) at pages 19-20 of this PDF document, in particular: "As of June... Continue reading
Posted Aug 29, 2014 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2014/08/29/takeda-pharma-actos-idUSL1N0QZ07I20140829 Takeda, Lilly lose bid to overturn $9 bln award for hiding cancer risk Fri Aug 29, 2014 1:10am EDT Aug 28 (Reuters) - Takeda Pharmaceutical Co Ltd and Eli Lilly & Co lost a bid to overturn a combined $9 billion punitive damage award by a U.S. jury for hiding cancer risks associated with their Actos diabetes drug, according to a court ruling. "Plaintiffs have pointed to sufficient evidence from which the jury could have concluded that the 'information' about bladder cancer contained in Actos labels did not adequately warn of the increased risk of cancer," U.S.... Continue reading
Neurology Medical Journal Article Reports Two-Times Increased Risk For This Nerve Damage Side Effect For New Users Of These Antibiotics (Posted by Tom Lamb at DrugInjuryWatch.com) The popular antibiotics Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin) are in a class of drugs called "fluoroquinolones". These antibiotics are commonly used for a verity of community and hospital acquired infections. In recent years case reports have linked Levaquin, Cipro, and Avelox with peripheral neuropathy, or serious nerve damage. As a result of the large number of cases of peripheral neuropathy in patients using Avelox, Cipro, and Levaquin being reported to the FDA, it issued this warning in August 2013: "FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection". Further, the FDA ordered the the manufacturers of these fluoroquinolone antibiotics -- Avelox: Bayer / Schering Plough / Merck; Cipro: Bayer; Levaquin: Janssen -- to increase their warnings about this adverse drug event on their respective product's labels. For example, this language was added to the Levaquin drug label (accessed 8/22/2014) in September 2013: 5.8 Peripheral Neuropathy Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or... Continue reading
Posted Aug 22, 2014 at Drug Injury Watch
FDA Drug Alert Warns That Linzess Should Not Be Used In Children Under Age 6 And Neither Safety Nor Efficacy Established For Those Under 18 Years Old (Posted by Tom Lamb at DrugInjuryWatch.com) Linzess (linaclotide) was approved by the FDA in 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation. It is from Forest Pharmaceuticals, Inc., who has advertisements for this relatively new drug on television and in magazines. As announced by the FDA by means of an August 15, 2014 MedWatch Safety Information email alert, in July 2014 there were several major label changes made to the following sections of the Linzess Prescribing Information (accessed 8/18/14): -- Boxed Warning; -- Contraindications (4); -- Warnings and Precautions, Pediatric Risk (5.1); and, -- Warnings and Precautions, Diarrhea. The new Linzess "Black-Box" Warning states: WARNING: PEDIATRIC RISK LINZESS is contraindicated … in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. …The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age _____________________________________________________________________ Free Linzess Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ And here is another one of the... Continue reading
Posted Aug 18, 2014 at Drug Injury Watch
While Prolia Is An Alternative To Bisphosphonates Such As Fosamax, It Has Similar Increased Risk Of Low-Stress Femur Fractures Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) The association between stress fractures of the femur, or atypical femoral fractures, and the use of bisphosphonate osteoporosis drugs such as Fosamax (alendronate) is relatively strong. It has been hypothesized that bisphosphonates cause an oversuppression of bone remodeling which contributes to atypical fracture of the femur. Prolia (denosumab) is an alternative approach to the treatment of osteoporosis that was approved by the FDA in 2010. Like bisphosphonates, Prolia is an antiresorptive drug. As such, it is not surprising that we are starting to hear about cases of stress fractures or low-stress fractures of the femur in patients using Prolia. And given the short time it has been on the market, we fully expect the number of femur fracture cases associated with Prolia to increase. Here are three recent case reports from themedical journals Bone and Acta Orthopaedica regarding Prolia and femur fractures: Bilateral atypical femoral fractures in a patient prescribed denosumab - a case report. Bone. 2014 Apr; 61:44-7. Epub 2013 Dec 31. "... A 59 year old woman sustained an atypical fracture... Continue reading
Posted Aug 12, 2014 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2014/08/08/us-pfizer-lipitor-lawsuits-insight-idUSKBN0G80E520140808 Pfizer confronts surge of lawsuits over Lipitor By Jessica Dye Fri Aug 8, 2014 1:22am EDT (Reuters) - Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public. In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000. Lawsuits began to be filed not long after the Food... Continue reading