October 2013

Due to a possible contamination with Listeria monocytogenes, Boston Salads and Provisions Company is recalling 222,959 pounds of ready to eat chicken salad products.  As reported by FoodSafetyNews.com, the contaminaited chcken salad prodcuts in question were made August 23rd, 2013 to October 14th, 2013 and were shipped to wholesalers in Massachusetts and New Hampshire.  Despite the fact that some of the products included in this recall may be expired, the U.S. Department of Agriculture’s Food Safetey and Inspection Service is worried that some of these products may have made their way to retail or consumer freezers.  If that is the case, containing the contamination will prove to be more challenging.

Infection with listeria, or Listeriosis is with antibiotics and any high risk person who has flu-like symptoms after eating contaminated food should contact healthcare providers or emergency medical services.  Some common signs of Listeriosis are loss of balance, convulsions,fever, muscle aches, and confusion.  The infection caused by listeria monocytogenes can cause miscarriages, stillbirths, and premature delivery of the baby.  Older adults or people with a weakened immune system are at a higher risk of listeriosis, an infection caused by listeria monocytogenes.  Pregnant women and their babies are also more likely to be infected than people with normal immune system strength.

The New Hampshire Department of Public Healh first discovered the contamination when two samples that had not been in contact both tested positive for listeria.  Once the New Hampshire Department of Public Health had become aware of the problem, the Massachusetts Department of Public Health was contacted, and intact samples of the product were tested.

After this evaluation found two samples that tested positive for listeria, the U.S. Department of Agriculture’s Food Safetey and Inspection Service was contacted.  As of yet, no details have been made public but further investigation may have identified a source of the contamination.  Federal and state public health partners such as the U.S. Food and Drug Administration and the New Hampshire/Massachusetts health departments have been closley working together on the investigation.

Thankfully, to-date there have not been any reports of illnesses from the contaminated products.

Headquartered in Indianapolis, Indiana, Eli Lilly and Company is a pharmaceutical company with offices all over the world.  Recently, the company developed a single-agent treatment for gastric cancer; a drug called Ramucirumab.  Ramucirumab is used if cancer continues to progress after initial chemotherapy.  And according to a report published 10-24-2013 by PharmaceuticalBusinessReview.com, the company recently received priority review status from the US Food and Drug Administration, in attempt to expedite the process of getting the drug approved for use by the public.

Cancer has the unique ability to manipulate the body’s healthy cells and make them work in favor of the cancer: new blood vessels will grow and adhere to the cancerous tumor, supplying it with all the nutritious blood it needs to grow and spread to other parts of the body.  Ramucirumab was designed to stop the signal from the cancer to form these blood vessels to the tumor.

A randomized, double blind phase III trial called REGARD was used for data that granted the priority review status for a biologics license application. This double-blind clinical trial tested Ramucirumab (plus the highest quality supportive care) vs. a placebo medicine (with the highest quality supportive care) for patients who had disease progression after chemotherapy.

The oncology vice president of product development and medical affairs of Eli Lilly and Company claims that Ramucirumab will the first type of FDA-approved therapy for this setting.  While all types of cancer are serious, stomach cancer is the second most common cancer world-wide and is often fatal.  Currently, Eli Lilly and Company is hoping for good results from three other Phase III trials of Ramucirumab in colon, hepatocellular, and lung cancer set to take place in 2014.  I too hope for the success of this drug.

In 2011, M. Elashoff, from the Larry L. Hillblom Islet Research Center at David Geffen School of Medicine and Department of Biomathematics at University of California, Los Angeles, published a study titled “Pancreatitis, Pancreatic, and Thyroid Cancer with Glucagon like Peptide-1-based Therapies”, wherein concerns regarding risk for pancreatitis and pancreatic and thyroid cancers are explored.  Glucagon like peptide-1-based therapy is a treatment that is gaining widespread use.

Dipeptidyl peptidase-4 inhibitors may cause cancer due to their ability to negatively affect immune function.  The study examined the US Food and Drug Administration’s database for reports that showed negative events with dipeptidyl peptidase-4 inhibitor sitagliptin and the glucagon-like peptide-1 mimetic exenatide (Byetta).  This information was from 2004-2009, and the control group of this study were adverse events connected with four other medications.  The report was looking for rates of reported pancreatitis, pancreatic and thyroid cancer, and all other cancers that may be associated with sitagliptin or exenatide.

Author M. Elashoff states “Use of sitagliptin or exenatide increased the odds ratio for reported pancreatitis 6-fold as compared with other therapies (P<2×10(-16)). Pancreatic cancer was more commonly reported among patients who took sitagliptin or exenatide as compared with other therapies (P<.008, P<9×10(-5)). All other cancers occurred similarly among patients who took sitagliptin compared with other therapies (P=.20).”

The information and data collected by this study showed to be consistent with case reports and animal studies on this subject: there was a clear indication of increased risk for pancreatitis with glucagon like peptide 1 based therapy.

Studies such as this can be used in a GLP-1 therapy pancreatic cancer lawsuit (such as a Byetta lawsuit, for example) to help demonstrate to a court that the manufacturers of exenatide (Byetta, Bydureon), liraglutide (Victoza), and sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), (Bristol-Myers Squibb, Novo Nordisk, and Merck, respectively) and other GLP-1 therapy drugs knew, or should have known, the risks associated with their products.  Because warning labels for these drugs have not included this information, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits have been filed around the world.

If you or a loved one used a GLP-1 therapy drug and suffered from pancreatitis or pancreatic cancer, you may be entitled to significant financial compensation from the manufacturer of the drug in question.  For a free, no-obligation case consultation, contact our team of Byetta lawyers, Victoza lawyers, and Januvia lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you and your loved ones deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Byetta Lawsuit / Victoza Lawsuits / Januvia Lawsuit Information page is a great place to start if you have any questions about GLP-1 therapy drugs and diabetes drug lawsuits.  Call today and see how we can help!

The objective of a study titled “Neonatal Abstinence Syndrome After in Utero Exposure to Selective Serotonin Reuptake inhibitors in Term Infants”, written by researchers from the Neonatal Intensive Care Unit at Schneider Children’s Medical Center of Israel, led by R. Levinson-Castiel was to determine the prevalence and clinical characteristics of neonatal abstinence syndrome in neonates both exposed and not exposed to selective serotonin reuptake inhibitors in utero.  The study was a cohort study taken place in tertiary care centers.  In all, there were 120 term infants used in this study.  Sixty of these infants had prolonged utero exposure to paroxetine hydrochloride (Paxil), fluoxetine (Prozac), citalopram hydrobromide (Celexa), sertraline hydrochloride (Zoloft), and venlafaxine hydrochloride (Effexor).

Levinson-Castiel writes “Neonatal abstinence syndrome was assessed with the Finnegan score as follows: score of 8 or above, severe; score of 4 to 7, mild; and score of 0 to 3, normal. All infants were followed up with a standardized protocol that included repeated Finnegan score assessments and cardiorespiratory monitoring until normalization of the Finnegan score.”

Shockingly, it was found that eight of ten neonates exposed to SSRIs showed some symptoms of a neonatal abstinence syndrome, and that 100 percent of all nonexposed neonates had a normal Finnegan score.  Levinson-Castiel further states “In neonates who developed severe symptoms, the maximum mean daily Finnegan scores were recorded within 2 days after birth, although maximum individual scores were recorded as long as 4 days after birth.”  Though long term effects of SSRI exposure are yet to be determined, neonatal abstinence syndrome was recorded in 30 percent of the neonates exposed to SSRIs.

If you or a loved one used an SSRI during pregnancy and your child was born with a congenital malformation, your family may be entitled to significant financial compensation from the manufacturer of the drug used for the undue injury caused to those close to you.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects lawyers, Prozac® birth defects lawyers, Celexa® birth defects lawyers, Zoloft® birth defects lawyers, and Effexor® birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you and your loved ones deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

Studies have shown that pancreatitis is associated with the use of exenatide (Byetta, Bydureon), liraglutide (Victoza), and sitagliptin (Januvia, Janumet, Janumet XR, Juvisync) and other glucagon like peptide 1 (GLP-1) receptor agonists.  The pancreatitis associated with these therapies and medications may increase the risks for pancreatic cancer.  Experiments done on mice and rats have shown that long term exposure to these GLP-1 drugs can cause C-cell proliferation and the formation of C-cell adenomas and carcinomas.

These findings may show that GLP-1 medications may cause medullary thyroid carcinoma in humans as well.  The purpose of a review written by Michael A. Nauck, from the American Diabetes Association was to discuss the evidence in favor and against the hypothesis that GLP-1 based therapies increase the risk of cancer.  Author Michael A. Nauck states in his review (titled “Do GLP-1–Based Therapies Increase Cancer Risk?”), “For the purpose of this review, GLP-1–based therapies are GLP-1 receptor agonists such as exenatide, liraglutide, and others or dipeptidyl peptidase-4 (DPP-4) inhibitors such as sitagliptin, vildagliptin, saxagliptin, alogliptin, and linagliptin.”

Nauck writes that most of the available data concluded from studies on this subject have examined exenatide and sitagliptin, and cites that chronic pancreatitis increases the risk for pancreatic cancer approximately 26 fold when compared to people not suffering from chronic pancreatitis.  The development of pancreatic cancer can have several influences, such as genetic influences, alcohol abuse, and certain drugs.  Nauck further states “Once chronic pancreatitis has been established, chronic inflammation and enhanced intraductal pressure due to stenosis of the pancreatic duct(s) may lead to the development of pancreatic carcinoma.”

It is widely accepted that chronic pancreatitis is associated an elevated risk for pancreatic cancer, but questions still remain about whether or not episodes of acute pancreatitis will have the same negative effects.  This is an important question due to the fact that most episodes of pancreatitis are connected with GLP 1 receptor agonist treatment may be episodes of acute pancreatitis.  Complicating the findings of studies such as the one described above, the risk of developing pancreatic cancer is twice as high among people who are regular smokers, for smoke from the cigarettes enter the blood and damage the pancreas.  Therefore, it is hard to tell if pancreatic cancer observed among smokers came from medications or from smoking.

Nonetheless, many studies have shown that GLP-1 therapy is associated with pancreatitis, and that pancreatitis can lead to pancreatic cancer.  Because the manufacturers of many GLP-1 therapy drugs such as Byetta, Victoza, and Januvia have failed to warn users of these risks, a number of Byetta lawsuits, Victoza lawsuits, and Januvia lawsuits have been filed.

If you or a loved one used Byetta, Victoza, Januvia, or another GLP-1 therapy drug, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Byetta lawyers, Victoza lawyers, Januvia lawyers, and GLP-1 therapy pancreatic cancer lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Byetta Lawsuit / Victoza Lawsuits / Januvia Lawsuit Information page is a great place to start if you have any questions about GLP-1 therapy drugs and diabetes drug lawsuits.

Quinilones are synthetic antibacterial drugs used for the treatment of urinary tract infections.  Quinilones are effective in the fight against bacteria because they prevent bacterial DNA from unwinding and multiplying.  This unwinding and duplicating process is how bacteria spread and infect different parts of the body.  Quinolones in the clinical setting belong to the subset fluoroquinolones.  Health care providers have recently raised awareness on infrequent toxicities associated with some of these types of drugs and drug classes.  The safety of quinilones is in question and some people in the medical world are not convinced the benefits outweigh the risks these drugs may pose.  There are certain steps that can be taken to protect a patient that include continued surveillance of safety and collecting tolerability data.

Medical researcher RC Owens Jr. from the Division of Infectious Diseases, Department of Clinical Pharmacy Services, at the Maine Medical Center, in Portland, Maine, worked on a review titled “Antimicrobial Safety:  Focus on Fluoroquinolones”, where one major aim was to assess the safety and tolerability of quinolones in human subjects.  The review found that negative event’s associated with the quinolone class was headaches, dizziness, nausea, and diarrhea.  These adverse events have to do with the gastrointestinal tract and central nervous system.  Effects on the gastrointestinal tract and central nervous system were mild and usually did not require the use of the medication to end.  While most side effects were not serious, complications with the cardiovascular system, musculoskeletal system, endocrine system, renal system, and central nervous system included tendinitis, tendon rupture, glucose homeostasis dysregulation, acute renal failure, and seizures.  The above complications (while uncommon) are serious and may cause the discontinuation of the therapy.

Author RC Owens Jr. states “Severe idiosyncratic adverse events are specific to individual agents that may share some structural congruity, such as the 1-(2,4)-difluorophenyl group shared by trovafloxacin (associated with hepatitis), temafloxacin (associated with hemolytic-uremic syndrome), and tosufloxacin (associated with eosinophilic pneumonitis)”.  This means that negative behavioral characteristics are specific to individual agents that are structurally similar and that shape determines their functions and qualities.  Rates of discontinuation for the currently marketed quinolones were seen at 4 percent from clinical trials.  Trovafloxacin and grepafloxacin are no longer available for general use due to their higher discontinuation rates (7% and 6.4 %).

In conclusion, this report found that the safety of marketed quinolones is similar to other antimicrobial classes.  Adverse effects are unusual but central nervous system effects are more common with the quinolone class.  Some susceptible populations may be more prone to rare adverse effects due to certain genetic factors, but this can be prevented by avoiding the specific quinolone.  It is not 100 percent clear if the therapeutic value outweighs the potential risks associated with the quinolone class.

Due to the fact that a number of people have used the drug Cipro (an oral quinolone) unaware of the risks associated with the drug, a number of Cipro lawsuits have been filed.  If you or a loved one used Cipro and experienced negative Cipro side-effects, do not hesitate to contact our team of Cipro lawyers at Dangerous Drugs for you may be entitled to significant financial compensation for the undue injury you have endured.

For more information, or for a free, no-obligation Cipro lawsuit consultation, reach our offices at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

The objective of a study done titled “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study” by  LH. Pedersen from the Department of Epidemiology, Institute of Public Health, Aarhus University, was to take a closer look between selective serotonin reuptake inhibitors taken during pregnancy and their ability to cause major congenital malformations.  The study was a population based cohort study that involved 493,113 children born in Denmark from 1996 to 2003.  The major malformations were categorized according to the European Surveillance of Congenital Anomalies with a different diagnostic grouping for heart defects and information on mothers and newborns were collected from nationwide registers on medical redemptions, delivery, and hospital diagnosis.

Author  LH. Pedersen states “Redemptions for SSRIs were not associated with major malformations overall but were associated with septal heart defects (odds ratio 1.99, 95% confidence interval 1.13 to 3.53). For individual SSRIs, the odds ratio for septal heart defects was 3.25 (1.21 to 8.75) for sertraline, 2.52 (1.04 to 6.10) for citalopram, and 1.34 (0.33 to 5.41) for fluoxetine.” That is to say that overall, risk for septal heart defects was increased more than 3-fold if a mother used Zoloft during pregnancy compared to controls.  Celexa use was shown to raise the risk for septal heart defects by a factor of 2.52,  and Prozac use raised the risk of having offspring with septal heart defects by 34%.

The use of more than one type of SSRI was associated with septal heart defects as well.  Overall, the absolute increase in the prevalence of malformations was low with individual drugs, the prevalence of septal heart defects was .5 percent among unexposed children and .9 percent for children whose mothers were prescribed an SSRI, but prevalence of malformations was found to be 2.1 percent among children whose mothers were prescribed more than one type of SSRI.

Pedersen concludes, stating simply “There is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy, particularly sertraline and citalopram. The largest association was found for children of women who redeemed prescriptions for more than one type of SSRI.”

This and other pieces of academic research like it may be used in a Zoloft septal heart defect lawsuit, Celexa septal heart defect lawsuit, or a Prozac septal heart defect lawsuit to demonstrate to a court that the manufacturers of these drugs knew, or should have known, the risk for septal heart defects associated with their products.  Due to the fact that the manufacturers of these drugs have failed time and again to warn women of the risk for birth defects associated with SSRI use, SSRI birth defect lawsuits have been filed all over the world.

For a free, no-obligation case consultation, contact our team of Zoloft® birth defects lawyers, Celexa® birth defects lawyers, Prozac® birth defects lawyers, and SSRI birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

A study conducted by the Department of Psychological Medicine, King Edward Memorial Hospital for Women, Subiaco, Australia, titled “Placental Transfer of SSRI and SNRI Antidepressants and Effects On The Neonate”, investigated placental transfer and neurobehavioural effects in neonates exposed to venlafaxine (Effexor), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine, fluoxetine (Prozac), escitalopram, and citalopram (Celexa).  The neonates of women receiving antidepressants during pregnancy were studied and cord and maternal drug concentrations were measured at birth.  Neurobehavioral tests were used to assess neonates and compared to controls.

Rampono states “Median cord/maternal distribution ratio was 0.7-0.86 (range) for SSRIs, 0.72 for the SNRI venlafaxine and 1.08 for the O-desmethyl metabolite.”  It was shown that exposed infants had abstinence scores significantly higher neonatal abstinence scores than controls on day 1.  Exposed infants also showed significantly greater brazelton scores for habituation, social interactive, motor and autonomic clusters, and serotonin.

This study found that transfer of SSRIs and SNRIs across the placenta were substantial.  Author Rampono J. further states that “Neonates developed mild behavioral symptoms in the early perinatal period but these were self-limiting and similar for both SSRIs and the SNRI venlafaxine.”

If you or a loved one used SSRI during pregnancy and your child was born with a birth defect, your family may be entitled to significant financial compensation from the manufacturer of the drug used for the undue injury, pain, and suffering incurred through no fault of your own.  At your convenience, contact our team of Effexor® birth defects lawyers, Zoloft® birth defects lawyers, Paxil® birth defects lawyers, Prozac® birth defects lawyers, Celexa® birth defects lawyers, and SSRI birth defect lawyers to receive a free, no-obligation case consultation.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

A team of medical researchers led by F. Rodriguez-Porcel (2011), from the Department of Psychiatry & Human Behavior at The University of Mississippi Medical Center in Jackson, conducted a study titled “Neonatal Exposure of Rats to Antidepressants Affects Behavioral Reactions to Novelty and Social Interactions in a Manner Analogous to Autistic Spectrum Disroders”, where it is demonstrated that neonatal exposure to selective serotonin reuptake inhibitors may have continuous effects on Long Evans rats.  Rodriguez-Porcel F states “Hyperserotoninemia and altered sensory processing are reported in autistic spectrum disorders (ASD). We hypothesized that early life exposure to SSRIs alters sensory processing, disrupts responses to novelty, and impairs social interactions in a manner similar to that observed in ASD.” (emphasis added)

Hyperserotoninemia is a very dangerous and life threatening reaction to a drug due to an overdose of a particular drug, or the recreational use of some drugs.  Hyperserotoninemia can be predicted due to excess serotonergic activity of the central nervous system.  Female and male Long Evans rats were given citalopram, buproprion, or fluoxetine from postnatal day.  These rats were tested for a novel tone before weaning, then they were tested for a response to a novel object and to a novel conspecific.

Rodriguez-Porcel F. goes on to state “In addition, rats were assessed for juvenile play behaviors (P32-P34) and later, we assessed sexual response to an estrus female in male rats (P153-184). Antidepressant exposure increased freezing after tone, diminished novel object exploration, and reduced conspecific interaction up to 3× compared to saline exposed rats.”  It was found that juvenile play greater reduced in antidepressant exposed males, and that exposure to the SSRIs disrupted male sexual behaviors and specific male responses to female proceptive behaviors were diminished.  The study concluded that neonatal exposure to antidepressants in rats lead to sensory and social abnormalities.

This study may be used as evidence in a Celexa birth defects lawsuit, a Wellbutrin birth defects lawsuit, or a Prozac lawsuit to help demonstrate to a court that the manufacturers of these drugs knew, or should have know, the risks associated with their products.  Due to the fact that many women have used SSRIs during pregnancy, uninformed about the risk for birth defects associated with these drugs, SSRI birth defects lawsuits are currently being filed all over the world.

If you or a loved one used SSRIs during pregnancy and your child was born with autism, contact our team of Celexa® lawyers, Prozac® lawyers, Wellbutrin® lawyers, and SSRI autism lawyers at the information provided below.  We have the resources, skills, and experience required to win the justice you deserve, even from the largest of pharmaceutical manufacturers.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help! Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

There is an ongoing debate in the medical community whether or not selective serotonin reuptake inhibitors have fetus damaging capabilities and can cause major congenital malformations for exposed offspring in utero.  There has been strong evidence that selective serotonin inhibitors have been associated with withdrawal symptoms.  A recent study published by researchers from University of La Laguna, in Tenerife, Spain, titled “Selective Serotonin Reuptake Inhibitors in Pregnant Women and Neonatal Withdrawal Syndrome: A Database Analysis”, investigated the use of these drugs in pregnant women might cause neonatal withdrawal syndrome.

Lead author of the above study EJ Sanz states “An association between paroxetine and neonatal convulsions was identified in December, 2001, by the data mining method routinely used to screen the WHO database of adverse drug reactions. An information component (IC) measure was used to screen for unexpected adverse reactions relative to the information in the database. We then assessed cases of neonatal convulsions and neonatal withdrawal syndrome associated with drugs included in the anatomical therapeutic chemical groups N06AB and N06AX.”

The study found that by November 2003, 93 cases of SSRI neonatal withdrawal syndrome had been reported.  These cases were thought to be adequate information to confirm a possible causal relation.  Of these cases, 9 were associated with sertraline, 7 with citalopram, 14 with fluoxetine, and 64 with paroxetine.  Sanz EJ. Concludes with “The IC-2 SD for the group became greater than 0 in the first quarter of 1991, and the IC increased to 2.68 (IC-2 SD 0.32) by the second quarter of 2003. For each individual compound, the IC-2 SD was greater than 0.”  In conclusion, this study found that SSRIs like paroxetine (Paxil) should be closely managed in the treatment of pregnant women with a psychiatric disorder.

This study and ones similar to it may be used in a Paxil neonatal withdrawal syndrome lawsuit to demonstrate to a court that the manufacturer of Paxil (GlaxoSmithKline) knew, or should have known, that Paxil is associated with neonatal withdrawal syndrome.  Due to the fact that the warning labels for Paxil have failed to include such information adequately, a number of Paxil birth defects lawsuits are currently being filed.

If you used Paxil during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation for the undue injury endured by your family.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.