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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
Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry (Posted by Tom Lamb at By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals, Inc. we first learned there was going to be a label change concerning Topamax and cleft lips in infants: Revisions to Section 8.1 to describe the most recent data pertaining to the risk of oral clefts in infants exposed to topiramate during pregnancy, based on data from the 2014 Annual Report from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Here is the revised Topamax (topiramate) Prescribing Information, updated October 2014 (accessed 11/20/14), with the above-referenced revision in section 8 USE IN SPECIFIC POPULATIONS, at 8.1 Pregnancy: Human Data Data from the NAAED Pregnancy Registry (425 prospective topiramate monotherapy-exposed pregnancies) indicate an increased risk of oral clefts in infants exposed during the first trimester of pregnancy. The prevalence of oral clefts among topiramate-exposed infants was 1.2% compared to a prevalence of 0.39% for infants exposed to a reference [antiepileptic drug (AED)]. In infants of mothers without epilepsy or treatment with other AEDs, the prevalence was 0.12%. For comparison, the Centers for Disease Control... Continue reading
Posted 2 days ago at Drug Injury Watch
Quoted from Testosterone treatment: Fountain of youth or heart attack risk? Jeff Swiatek November 21, 2014 It's almost predictable. First came the drug company ads aimed at older men. Feeling tired, irritable, lost your sex drive? Try our testosterone product. Then came the response ads from trial lawyers. Suffered a heart attack or stroke while taking testosterone? Sue 'em. It's the latest battle over drug side effects, and the stakes are high. Artificial testosterones are among the best selling drugs on the market. More than 2 million American men have prescriptions for more than half a dozen products that... Continue reading
Thank you for your comment. Yes, and there were Pradaxa lawsuits filed which are the subject of a recent large settlement by Boehringer Ingelheim, the "responsible" drug company. Now there are Xarelto lawsuits being filed, with Eliquis cases under investigation as possible lawsuits to be filed in the near future. Safety before profits seems the better course for pharmaceuticals. Tom Lamb
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A Reversal Agent For Eliquis Currently Under Development Comes Too Late For People With Trauma-Induced Bleeding Incidents, Some Who Bled To Death (Posted by Tom Lamb at Eliquis (apixaban) was the last of the three "new-generation" anticoagulants to make it to the market. It was approved by the FDA in 2012. Pfizer and Bristol-Myers Squibb are the two drug companies which share the profits and responsibility for Eliquis. The first such new blood thinner released was Pradaxa (dabigatran), a direct thrombin inhibitor by Boehringer Ingelheim. Next came Xarelto (rivaroxaban) by Johnson & Johnson, which was approved in 2011. Significantly, none of these three blood thinners -- Pradaxa, Xarelto, and Eliquis -- currently have an approved antidote for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. We wrote about this drug safety problem in this article, "Eliquis And Xarelto, Like Pradaxa, Linked To Serious Bleeding Events Due To Fact No Antidote Available", which we posted back in September 2014. Now we have an update on this drug safety situation as regards Eliquis, at least. We start with the fundamental fact that Eliquis is a Factor Xa inhibitor. In response to the "no-antidote" Eliquis issue, the company Portola... Continue reading
Posted Nov 17, 2014 at Drug Injury Watch
Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment (Posted by Tom Lamb at Most adverse drug reaction case reports associated with the still relatively new anticoagulant Xarelto (rivaroxaban) involve serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding as well as irreversible life-threatening trauma-induced atypical bleeding incidents. A recent article, however, published by the medical journal JAMA Internal Medicine, "Symptomatic Hepatocellular Liver Injury With Hyperbilirubinemia in Two Patients Treated With Rivaroxaban", discusses a different serious Xarelto side effect: drug-induced liver injury / liver damage. _____________________________________________________________________ Free Xarelto Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ From a medical site summary about this recent Xarelto liver safety study, "Rivaroxaban and Liver Injury: Case Studies Add to Safety Questions", we get these facts: A case study in JAMA Internal Medicine reports on two patients that experienced severe liver injury onset during treatment with the oral anticoagulant [Xarelto (rivaroxaban)]. The first patient was a 52-year-old man who developed severe lobular hepatitis two months after initiation of [Xarelto (rivaroxaban)] 10mg/day for the prevention of deep vein thrombosis (DVT) after internal fixation of a tibia fracture. The preserved lobular architecture and lack of fibrosis... Continue reading
Posted Nov 10, 2014 at Drug Injury Watch
To start, I am sorry to hear about your unfortunate experience using the generic version of Zocor. Unfortunately, what you heard about the legal situation is correct. 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). 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'." I wish you the best in all aspects going forward. Tom Lamb
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Finding Applies Also To ED Drugs Cialis, Levitra, Staxyn, and Stendra, As Well As Pulmonary Arterial Hypertension (PAH) Medications Revatio And Adcirca (Posted by Tom Lamb at About six months ago we posted this item, "Viagra May Increase Risk Of Melanoma In Men Who Have Used This ED Drug, According To An April 2014 Medical Journal Article", in which we reported that Viagra (sildenafil), a popular erectile dysfunction (ED), appeared to increase the risk for malignant melanoma, a potentially fatal form of skin cancer. That medical journal article, "Sildenafil Use and Increased Risk of Incident Melanoma in US Men: A Prospective Cohort Study", was published by JAMA Internal Medicine in April 2014. Since then, there has been some commentary pieces written by medical reporters about this Viagra - melanoma study. First, from the American Council on Science and Health (ACSH) web site, there is "Viagra and melanoma correlation: Is it real?". From that article, we get this apparent validation of the underlying medical study: Unlike many of the junk studies we routinely lambaste here, this one is well run and also has a biologically plausible mechanism to explain the findings. It is also a prospective study—one planned in advance... Continue reading
Posted Nov 3, 2014 at Drug Injury Watch
Quoted from Stronger warning on Iclusig blood clot risk The Pharmaceutical Journal, 30 OCT 2014 Warnings about the risks of developing a blood clot or blocked artery with Iclusig (ponatinib), a leukaemia treatment, are to be made more robust, following the results of a European Medicines Agency (EMA) review. The EMA said that any risks would be likely to be linked to dosage but insufficient data meant that it did not have enough information to recommend that the existing starting dose of 45mg a day should change. The agency announced that it is launching a study into the safety... Continue reading
Quoted from Takeda, Lilly Win 99.6% Cut in Actos Punitive Damages By Jef Feeley 2014-10-28 Takeda Pharmaceutical Co. and Eli Lilly & Co. won a more than a 99 percent cut in a $9 billion punitive damages award over claims the drugmakers hid the cancer risks of their Actos diabetes medicine. Jurors properly found officials of Osaka, Japan-based Takeda and Indianapolis-based Lilly intentionally hid the health risks of the drug and should pay punitive damages, U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, ruled. Still, the panel’s decision to order Takeda to pay $6 billion and Lilly $3 billion... Continue reading
Cymbalta Discontinuation Syndrome / Symptoms Include "Brain Zaps", Extreme Mood Swings (anger, irritability), And Neurological Or Physical Problems (Posted by Tom Lamb at While generally thought of as an antidepressant drug, Cymbalta (duloxetine) from Eli Lilly and Company has been approved by the FDA for use by patients diagnosed with: Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathic Pain; Fibromyalgia; and, Chronic Musculoskeletal Pain Based on prescriptions for these several medical conditions and others -- by means of so-called "off-label" prescribing -- Cymbalta became a blockbuster drug for Lilly after being approved by the FDA in 2004. The first generic versions of Cymbalta were approved by the FDA on December 11, 2013. The Prescribing Information, or drug label, for Cymbalta (duloxetine) (accessed 10/27/14) indicates that stopping this drug is no more problematic than other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors). From this section of the label, 5.7 Discontinuation of Treatment with Cymbalta: Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at 1% or greater and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, headache,... Continue reading
Posted Oct 27, 2014 at Drug Injury Watch
Quoted from 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
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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 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 Oct 21, 2014 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 ( I wish you the best in all aspects going forward. Tom Lamb
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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 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 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 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, "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 Alabama federal judge: Time to end nationwide litigation against Pfizer anti-smoking drug Chantix By Kent Faulk | 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 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 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 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 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 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 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 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