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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
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 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 5 days ago 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 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 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 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
Benefit / Risk Assessment Of Statins Like Lipitor May Depend On Whether It Is A Medically Necessary Drug Therapy For The Particular Patient (Posted by Tom Lamb at There is an ongoing debate in the medical community about whether cholesterol drugs like the very popular Lipitor from Pfizer is over-prescribed in part due to aggressive marketing by the drug company. Certainly, there is a population of patients for which a statin drug like Lipitor is medically necessary to maintaining their health. On the other hand, however, some people would probably be better off addressing their cholesterol problem with a healthier diet and more exercise rather than by just taking a pill as the "fix" for the rest of their life. This is especially true when regularly taking a statin drug such as Lipitor forever going forward can cause the person to develop type 2 diabetes or diabetes mellitus. In fact a recent medical journal article reported on a medical study that had as its objective to investigate the relationship between the regular use of statins such as Lipitor and the risk of developing diabetes. From this article, "Statins and the Risk of Diabetes: Evidence From a Large Population-Based Cohort... Continue reading
Posted Aug 1, 2014 at Drug Injury Watch
Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs (Posted by Tom Lamb at The safety issues concerning the popular testosterone replacement therapy (TRT) products AndroGel, Axiron, and Testim continue to be be debated with mixed decisions in different arenas. We will start with the FDA, which on July 17, 2014 issued this "September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement": Agenda: The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. We note that the Bone, Reproductive and Urologic Drugs Advisory Committee was formerly known as the Reproductive Health Drugs Advisory Committee. Next, on July 15, 2014 Health Canada issued this "Information Update - Possible cardiovascular problems associated with testosterone products": Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.... Health Canada has recently completed a safety review on testosterone replacement... Continue reading
Posted Jul 18, 2014 at Drug Injury Watch
Quoted from FDA committee to discuss adverse effects of testosterone products Thu Jul 17, 2014 (Reuters) - The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy. The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee. ( [Article continues at original source] Related articles AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting... Continue reading
Quoted from Heart Warnings for Low T Drugs? Health Canada Says ‘Yes,’ but FDA Isn’t Sure July 17, 2014 By Ed Silverman File this under ‘a study in contrasts.’ Within 24 hours, two regulatory agencies took notably different positions on the virtues of low testosterone medications. Although widely touted for boosting male sex drive, moods and energy, they have also been controversial because some studies found the medicines may pose cardiovascular risks. Yesterday, Health Canada asked drug makers to update product labeling after a review “found a growing body of evidence from published literature and case reports… for serious... Continue reading
This Severe Diarrhea Side Effect Is Caused By Olmesartan, Which Is Also Found In Azor, Tribenzor, And Benicar HCT Blood Pressure Medications (Posted by Tom Lamb at Back in May 2014 we made reference to this medical article, "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease", published online by the Journal of Pharmacy Practice, in our post entitled Benicar (Olmesartan) Associated With Sprue-Like Enteropathy, Which Is A Chronic / Severe Diarrhea Condition That Can Be Misdiagnosed As Celiac Disease. More recently, in June 2014, on the Family Practice News Digital Network, we found this news report, "Olmesartan can cause celiac disease mimicker". The antihypertensive agent olmesartan is associated with increased risk of a severe sprue-like enteropathy, as highlighted in a nationwide French cohort study. This olmesartan-related illness is characterized by villous atrophy, severe chronic diarrhea, and weight loss, with negative serology for celiac disease. The hospitalization rate for this disorder is time dependent. The risk doesn’t increase significantly until after the first year on therapy but climbs steeply thereafter, Dr. Myriam Mezzarobba reported at the annual Digestive Disease Week. Importantly, angiotensin receptor blockers other than olmesartan (Benicar) were not associated with an increased risk... Continue reading
Posted Jul 14, 2014 at Drug Injury Watch
All Testosterone Therapy Drugs Need To Warn About Blood Clots Side Effects Like DVT And PE; Older Depo-Testosterone Product May Be Safer Than New Gels Such As AndroGel And Testim (Posted by Tom Lamb at In the first part of this summer there has been a flurry of drug-safety activity as regards the popular testosterone replacement therapy (TRT) products like Axiron, AndroGel, Testim, and Depo-Testosterone. We will start with two recent FDA developments: 1. Testosterone: Drug Information Update- FDA adding general warning to testosterone products about potential for venous blood clots [Issued 6/19/14] The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).... Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products. 2. Potential... Continue reading
Posted Jul 7, 2014 at Drug Injury Watch
Benicar, Azor, Tribenzor, Benicar HCT, And Other Blood Pressure Medicines Containing Olmesartan: Cardiovascular Mortality In Not A Side Effect Risk, Or Is It (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE: "FDA Once Again Reaches Conclusions At Odds With Its Own Staff" (Forbes, Larry Husten, 7/14/14) Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.... (7/15/14) ______________________________________________________________________________ UPDATE: Recent Benicar label change according to the June 13, 2014 FDA Letter: Under ADVERSE REACTIONS/Post-Marketing Experience, the following test [sic] was added: Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.... Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the... Continue reading
Posted Jun 30, 2014 at Drug Injury Watch
Quoted from FDA asks for wider warning on testosterone products June 20 Fri Jun 20, 2014 June 20 (Reuters) - The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. The regulator cited post-market reports of such clots for the warning. The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia. ( Continue reading
Recent Canadian Study Published In BMJ Medical Journal Suggests The Increased Risk Of Diabetes Seems To Be Highest In The First Four Months Of Statin Use (Posted by Tom Lamb at According to the Parke-Davis, Division of Pfizer, Prescribing Information for Lipitor (accessed 6/18/14): [LIPITOR pills are:] White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium. The recommended starting dose of LIPITOR is 10 or 20 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. In our January 2014 article, "Pfizer's Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women", we listed some of the medical journal articles reviewed by the FDA prior to issuing its February 2012 Lipitor - diabetes warning. More recently, in May 2014, BMJ (formerly known as the British Medical Journal) published this article, "Higher potency statins and the risk of new diabetes: multicentre, observational study of administrative databases", which further implicates higher doses of Lipitor as a possible cause of new-onset Type-2 diabetes in some adult women. From the Abstract for this May 2014 BMJ aritcle: Results In the first two... Continue reading
Posted Jun 18, 2014 at Drug Injury Watch
Quoted from Bayer faces law suits in United States over Xarelto -paper FRANKFURT, June 14 Sat Jun 14, 2014 FRANKFURT, June 14 (Reuters) - Germany's Bayer AG faces its first law suits in the United States over anti-clotting drug Xarelto, one of its top five medicines, the Frankfurter Allgemeine Zeitung newspaper reported on Saturday, citing company sources. There are fewer than ten suits so far, the paper cited one company insider as saying. It gave no details of the suits. A Bayer spokesman declined to comment on the newspaper's report but said the drug's safety profile since its launch... Continue reading
Bayer Reports That As Of April 8, 2014 Settlement Negotiations Have Resolved "approximately 8,560 claimants in the U.S. for a total amount of about US$1.74 billion" (Posted by Tom Lamb at Soon before the first federal court MDL trial was scheduled to start back in January 2012 Bayer decided to begin to attempt to negotiate settlements for YAZ / Yasmin / Ocella / Gianvi blood clot lawsuits, e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE), on a case-by-case basis. And while Bayer has settled a significant number of these cases over the past two years, there are still thousands of more drospirenone (DRSP) birth control DVT and PE lawsuits that have not been negotiated to a final settlement agreement, yet. As of early April 2014 there were reportedly about 2000 unresolved YAZ / Yasmin / Ocella / Gianvi claims -- and that number apparently does not include the filed and unfiled Beyaz and Safyral blood clot cases, as there is not any mention of those cases by Bayer in recent their recent DRSP drug injury litigation updates. ______________________________________________________________________________ YAZ/Yasmin/Ocella/Gianvi/Beyaz/Safyral Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ From the Stockholders’ Newsletter First Quarter 2014 (PDF document) issued by... Continue reading
Posted Jun 11, 2014 at Drug Injury Watch
Merck Corporate SEC Filing for First Quarter 2014 Provides Information About Numbers Of Lawsuits In Various Court Jurisdictions Being Worked Up For Some Possible Trials In The Future (Posted by Tom Lamb at We have our first 2014 update from Merck on the Fosamax - femur fracture litigation. From the Merck SEC Form 10-Q for the quarterly period ended March 31, 2014 (at page 19 of PDF document): [In the Fosamax Femur Fracture MDL] Judge Pisano set a May 5, 2014, trial date for the bellwether trial of a case in which the alleged injury took place after January 31, 2011. Following the completion of fact discovery, the court selected Sweet v. Merck as the next Fosamax Femur Fracture MDL case to be tried on May 5, 2014, but plaintiffs subsequently dismissed that case. As a result, the May 2014 trial date was withdrawn. As of March 31, 2014, approximately 2,785 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. As of March 31, 2014, approximately 525 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate... Continue reading
Posted Jun 6, 2014 at Drug Injury Watch
Quoted from $100 million NuvaRing settlement finalized By Associated Press, June 5, 2014 ST. LOUIS — A $100 million settlement involving NuvaRing, a birth-control device linked to sometimes-fatal side effects, will stand now that the vast majority of claimants have chosen to opt into the agreement, those involved in the lawsuits said Thursday. U.S. District Judge Rodney W. Sippel of St. Louis approved the settlement in February, but NuvaRing maker Merck & Co. had the right to abandon the deal if less than 95 percent of eligible claimants opted in. The lead attorney for the claimants, St. Louis lawyer... Continue reading
Adverse Events Monitoring Data And Medical Studies Have Identified Possible Increased Risk For Cardiovascular Problems Including Arrhythmias (Posted by Tom Lamb at In early May 2014 the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) announced it was reviewing the safety of hydroxyzine-containing medicines because of cardiac concerns. Hydroxyzine is a medicine used generally by mouth or sometimes by injection for: relief of anxiety disorders; premedication before surgical procedures; relief of urticaria or various other conditions associated with pruritus (itching); and, treatment of sleep disorders. In the US, hydroxyzine-containing drugs include Atarax (Roerig, a division of Pfizer) and Vistaril (Pfizer Labs and Roerig, each a division of Pfizer). From this May 8, 2014 EMA Announcement, "Review of hydroxyzine-containing medicines started": The review was requested by the Hungarian medicines agency (GYEMSZI-OGYI) over concerns about the side effects of these medicines on the heart. This followed an examination of the benefits and risks by a marketing authorisation holder for hydroxyzine. Data from drug safety monitoring (pharmacovigilance) and published experimental studies identified a potentially increased risk of alterations of the electrical activity of the heart and arrhythmias (irregular heartbeats).... The European Medicines Agency will now review the available data on the... Continue reading
Posted Jun 5, 2014 at Drug Injury Watch
PTC/IIH Symptoms Include Migraines With Blurred Or Double Vision, Temporary Blindness, Other Visual Problems, And Wooshing Or Ringing In The Ear (Posted by Tom Lamb at Mirena is an intrauterine system (IUS) from Bayer Healthcare Pharmaceuticals, Inc. that releases 20 μg/day of levonorgestrel. Basically, the Mirena releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control. The FDA approved Mirena in December 2000 and it is used by more than 2 million women in the US. The Prescribing Information for Mirena (accessed 5/30/14) does not warn about neurological conditions such as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. In fact, the Mirena Prescribing Information (also known as the package insert or label) makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH. Pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) is a non-stroke neurological condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure. PTC/IIH symptoms include: severe migraines or migraine-like headaches with blurred vision diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies papilledema, or optic disc swelling, due to increased intracranial pressure a “whooshing” or ringing in the... Continue reading
Posted May 30, 2014 at Drug Injury Watch
Quoted from Boehringer Pays $650 Million to End Blood Thinner Cases By Jef Feeley - May 28, 2014 Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths. Boehringer, slated to face the first trial in September of claims there was no antidote to stop bleed-out deaths among Pradaxa patients, is seeking to settle about 4,000 suits, company officials said in a statement today. That would provide an average per-case payout of $162,500. The settlement... Continue reading
More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE: Boehringer Pays $650 Million to End Blood Thinner Cases (5/28/14, Bloomberg) Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths.... (5/28/14) ______________________________________________________________________________ Earlier this month the drug company Boehringer Ingelheim said a new analysis of a company-funded study of 18,000-patients, known as RE-LY -- which the company used to win FDA approval of its controversial blood thinner Pradaxa -- turned up 22 "new" serious bleeding events that were not included in the original study report. According to a May 14, 2014 news article, "Boehringer Says New Bleeding Cases Found in Pradaxa Study": Any correction to the original study, which was published in the New England Journal of Medicine in September 2009, would have to come from the researchers, Smith said. If a correction is made, it would be the second to the trial. The researchers issued a correction in November 2010, saying they... Continue reading
Posted May 21, 2014 at Drug Injury Watch
Quoted from Lawyers ask for $60 million for Clark County women who took diabetes drug (Jeff Scheid/Las Vegas Review-Journal) By DAVID FERRARA LAS VEGAS REVIEW-JOURNAL A pair of Clark County women deserve at least $60 million after developing bladder cancer from taking the diabetes drug Actos, one of their attorneys told a jury Monday. The lawyers for Delores Cipriano, 81, and Bertha Triana, 80, have said they plan to seek billions of dollars more in punitive damages from the Japan-based drug maker Takeda as the case wraps up this week. After a three-month trial that started in Las Vegas... Continue reading
Quoted from Medtronic's Infuse Moves From Operating Room to Courtroom Published: May 18, 2014 By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today Three years after back surgery, Grace Nestler-Bramm learned that a drug designed to repair her spine was causing new bone growth, growth that was wrapping around the spine and compressing nerves. By then it was too late. The bony overgrowth associated with Infuse already had done irreparable damage. She is now disabled by pain, and has difficulty walking -- often needing a cane or wheel chair when she leaves her home. Doctors have told her that additional... Continue reading
Bloomberg News By Michelle Fay Cortez - May 14, 2014 Boehringer Ingelheim GmbH said a new analysis of a company-funded study used to win approval of the blood thinner Pradaxa found 22 serious bleeding events that weren’t included in the original report. Additional events were found in patients in each of the three arms of the 18,000-patient study known as RE-LY. Five more complications were seen among those taking a 110-milligram dose of the drug, 11 among those on a 150-mg dose and six in the patients using warfarin. Pradaxa became the first alternative to warfarin, the standard of care... Continue reading
This Diarrhea With Weight Loss Is Also A Side Effect Of Benicar HCT, Azor, And Tribenzor -- Other Blood Pressure Medicines Containing Olmesartan (Posted by Tom Lamb at An association between the serious side effect sprue-like enteropathy and the oral angiotensin-receptor blockers (ARBs) Benicar, Benicar HCT, Azor, and Tribenzor and has been getting increased attention in the medical literature. As pointed out by the FDA in July 2013 when it issued this MedWatch alert, "FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil", severe and chronic diarrhea with substantial weight loss has been reported in patients taking Benicar and the other related drugs months to years after they first started using these blood pressure pills. _____________________________________________________________________ Free Benicar Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ The most recent medical article we have seen on this still emerging drug safety issue was published online by the Journal of Pharmacy Practice in late March 2014. From the Abstract for "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease" we get this information: Objective: To review the evidence of an association between [Benicar, Benicar HCT, Azor,... Continue reading
Posted May 14, 2014 at Drug Injury Watch