Anti-Smoking Drug Suicide Risks Questioned by New Study

Published: October 15th, 2013

Following concerns over psychiatric side effects associated with some anti-smoking drugs, researchers indicate that a new study was unable to find a link between and use of Chantix, Wellbutrin or Zyban and an increased risk of suicide.  

According to findings published last week by the British Medical Journal, researchers from the University of Bristol could not identify a link between smoking cessation drugs and an increased risk of suicide.

The study comes after the makers of Chantix have settled thousands of lawsuits over claims that the drug caused users to experience psychological problems, including suicidal tendencies and violent, irrational behavior.

Researchers looked at data on 119,546 men and women who used a smoking cessation product between September 2006 and October 2011. Of those, 6,741 used bupropion, sold under the brand names Wellbutrin and Zyban, and another 31,260 used Chantix. The rest used some other smoking cessation products, such as nicotine replacement therapy (NRT).

The study found that there was no evidence that patients prescribed Chantix, Wellbutrin, or Zyban were at higher risk of fatal or non-fatal self harm or depression. The researchers determined that according to their findings there was no such risk.

Similar findings were reported last month in the Annals of Internal Medicine by researchers from the University of California and the Department of Veterans Affairs, which also failed to find a link between Chantix side effects and an increased suicide risk.

Chantix Suicide Concerns

Chantix (varenicline) is a Pfizer drug designed to help smokers quit. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, a few years after the drug was introduced and heralded as a potential blockbuster medication in 2006, reports began to surface of users committing suicide or engaging in sudden, unusual behavior.

In June 2009, the FDA added a 

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OxyElite Pro Liver Problems, Hepatitis Cases Highlighted by CDC

Published: October 15th, 2013

Federal health officials have issued a new report that provides further details about an outbreak of acute hepatitis and liver failure linked to the recalled OxyElite Pro dietary supplement.

According to the latest issue of the U.S. Centers for Disease Control and Prevention (CDC)’s Morbidity and Mortality Weekly Report, at least 29 people have been diagnosed with liver problems after using OxyElite Pro.

Concerns about the dietary supplement were first raised after at least seven reports of acute hepatitis were reported in Hawaii in September. However, since then, nearly 45 cases have been reported to health officials with at least 29 confirmed diagnoses.

The FDA issued a warning about the potential risk of OxyElite Pro liver injury on October 8, indicating that the weight-loss and muscle-building supplement had been identified as the likely cause an outbreak of acute hepatitis and liver failure.

Late last week, the Hawaii Department of Health (HDOH) called on all stores in the state to recall OxyElite Pro from their shelves. The largest retailer, GNC, held out but has finally agreed to do so and the product is no longer available for sale in Hawaii. The HDOH has also embargoed shipments of the supplement until further notice. USPLabs, the manufacturer, has ceased sales of OxyElite Pro on its website.

The first known OxyElite Pro case was identified in April, after a user showed signs of liver problems after having taken the supplement within the last two months. HDOH was notified after seven patients were diagnosed with acute hepatitis and fulminant liver failure. All seven had used OxyElite Pro. A public health alert went out and the other cases were discovered.

To date, at least one OxyElite Pro users has died, two received liver transplants, 11 were hospitalized and two remain hospitalized.

Health officials used data from the National Poison Data System and the United Network for Organ Sharing. Only four cases have been detected outside of Hawaii, but all four used either OxyElite Pro or another weight loss or muscle-building supplement. One of the four was a resident of Hawaii who obtained the product in Hawaii but was diagnosed in a different state.

The FDA is currently analyzing samples of OxyElite Pro and the results of the tests are pending, the CDC report notes.

“While the investigation is ongoing and these data are preliminary, clinical data, laboratory tests, and histopathology of liver biopsy specimens collected thus far suggest drug- or herb-induced hepatoxicity,” the CDC reports.

The CDC notes that similar findings have been linked to exposure to a number of dietary supplements, but the liver toxicity side effects usually resolves after the subject stops using the product. The CDC urges doctors treating patients with acute hepatitis to ask about dietary supplement use and report patients meeting case definition to local or state health departments and to the FDA.

Weight Loss and Body Building Supplement Problems

This is the latest body building supplement linked to cases of severe liver damage and liver failure. In May 2012, researchers presented a study at the Digestive Disease Week conference in San Diego that found that about 18% of all liver injury cases may be caused by dietary and herbal supplements. Body building supplements accounted for 34% of those, while weight loss supplements represented more than a quarter of the liver injury cases.

Herbal and dietary supplements are often not regulated by the FDA unless they have previously been found to be dangerous. This often means that there is little information on potential side effects and manufacturers often conduct little, if any, clinical trials to establish the safety and effectiveness of the products.

Dietary supplements in particular came under increased scrutiny by federal regulators in the wake of a Hydroxycut recall issued in May 2009, after the FDA identified a number of reports where users suffered serious and potentially life-threatening liver damage. In July of that year, the FDA warned consumers not to take dietary supplements which contained ingredients identified as steroids. The agency recommended that anyone taking dietary supplements containing steroids should immediately see a doctor if they showed signs of liver problems.

Related ArticlesOxyElite Pro Supplement May Be Linked to Hepatitis Cases: FDA, CDC (10/9/2013)Side Effects of Dietary, Body Building Supplements Linked to Liver Damage (5/31/2012)Hydroxycut Liver Damage Cases Highlighted in New Study (2/15/2010)M-Drol Lawsuit Filed Over Liver Damage From Dietary Supplement (12/16/2009)Hydroxycut Liver Failure Lawsuit Filed Following Recall (6/16/2009)Tags: Dietary Supplement, Hawaii, Hepatitis, Hydroxycut, Hydroxycut Recall, Liver Failure, OxyElite

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Effexor Lawyers Seek Leadership Roles in Federal Birth Defect Litigation

Published: October 15th, 2013

In advance of an upcoming status conference in the federal Effexor litigation, several attorneys have submitted applications for leadership roles in the coordinated pretrial proceedings established for lawsuits brought by families throughout the country who allege that their children were born with birth defects following Effexor exposure during pregnancy.

In August, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Effexor birth defect lawsuits brought in U.S. District Courts nationwide as part of an MDL, or Multidistrict Litigation. The cases are centralized before U.S. District Judge Cynthia M. Rufe for coordinated handling in the Eastern District of Pennsylvania.

An initial status conference in the Effexor MDL is scheduled for October 26, at which time lawyers involved in the litigation will meet to discuss the organization and structure of the issues.

On October 1, Judge Rufe issued a Case Management Order (PDF) appointing Mark S. Cheffo to serve as interim Liaison Counsel for the Defendants and Stephen A. Corr to serve as interim Liaison Counsel for all plaintiffs, charged with ensuring that orders and notices from the Court are transmitted to various lawyers representing families who have brought a claim in the MDL.

The Interim Liaison Counsel have also been ordered (PDF) to submit written position statements before the hearing, outlining each parties’ understanding of the facts involved in the litigation and the critical legal and factual issues.

In the meantime, a number of different attorneys have submitted applications to serve in various leadership roles in the litigation, including as Plaintiffs Lead Counsel or a member of a Plaintiffs’ Steering Committee.

Following the initial status conference later this month, Judge Rufe is expected to appoint a group of plaintiffs lawyers to take various actions throughout the pretrial proceedings and any bellwether trial process that would be for the benefit of all families who have brought a case. These Effexor lawyers will conduct and coordinate discovery and take various actions on behalf of plaintiffs at hearings and meetings before the court, as well as negotiate and enter potential stipulations or settlements with the Defendants.

Effexor Birth Defect Lawsuits

There are currently about 50 product liability lawsuits pending in the MDL involving families who allege that Pfizer failed to adequately warn about the risk of birth defects from Effexor pregnancy use. However, given the widespread use of of the medication, it is expected that there will ultimately be hundreds of claims centralized before Judge Rufe as Effexor lawyers continue to review and file additional cases.

The Effexor MDL was established to reduce duplicative discovery across a large number of cases, to avoid inconsistent rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Effexor (venlafaxine) belongs to a class of antidepressants known as serotonin-norepinephrine reuptake inhibitors (SNRIs), which are very similar to the more popular selective serotonin reuptake inhibitors (SSRIs) such as Zoloft. SNRIs are known to have many of the same side effects as SSRIs.

All of the lawsuits involve similar allegations that Pfizer’s Wyeth subsidiary failed to adequately warn consumers or the medical community about the pregnancy risks with Effexor and the impact the medication may have on unborn children.

Plaintiffs claim that there were signs of the potential pregnancy side effects during clinical trials on animals and that there were indications that Effexor may affect children during pregnancy following post-marketing data as well. The lawsuits allege that Wyeth aggressively marketed the drug as safe for pregnant women, when no such assertion could be justified when looking at the scientific data.

Following the coordinated pretrial proceedings in the MDL, including potential

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Pomalyst Side Efffects May Include Birth Defect Risk, U.K. Doctors Warned

Published: October 16th, 2013

The makers of the cancer drug Pomalyst are warning doctors in the U.K. that the drug, known there as Imnovid, could result in birth defects that put newborns’ lives at risk.  

According to report by PharmaTimes, Celgene Corp. sent a letter to healthcare professionals in the U.K. warning that the active ingredient, pomalidomide, is structurally similar to thalidomide; a drug known to cause birth defects. The drug was approved in the U.K. in August. It has been on the U.S. market since February.

It does not appear that any similar letter has been sent physicians in the U.S. However, the drug, approved to treat multiple myeloma, was released in the U.S. with a black box warning that it is a chemical analogue of thalidomide. The FDA warned that women of a child-bearing age who could get pregnant must be tested to confirm that they are not pregnant before taking Pomalyst and requires both men and women taking the drug to comply with contraception requirements.

Because of the risk of birth defects, Pomalyst is only available in the U.S. through a Risk Evaluation and Mitigation Strategy (REMS).

Thalidomide was first released as a morning sickness drug in 1957. Four years later, it was removed from the market after it was determined that the thalidomide caused major birth defects when used during pregnancy. It was the first product that established medications could cross the placental barrier and cause harm to a fetus.

It is estimated that between 10,000 and 20,000 children were born worldwide with birth defects from thalidomide. It’s impact was limited in the United States because the FDA denied the drug approval, saying that it needed to be more thoroughly tested. However, the drug was given to doctors in the U.S. during its clinical testing phase and it is unclear how many children it affected.

Thalidomide is sold under the brand name Thalomid and is used for the treatment of multiple myeloma. In September 2012, the German company that initially marketed the drug issued an apology to those affected by thalidomide birth defects and commissioned a statue in Stolberg, Germany in honor of the drug’s victims.

Related ArticlesBirth Defect Rates Increasing Among Twins, Triplets: Study (2/11/2013)Thalidomide Birth Defect Risks Result in Apology 50 Years Later (9/5/2012)Prenatal Use of NSAID Painkillers Linked to Birth Defect Risk: Study (3/27/2012)Birth Defect Class Action Lawsuit To Move Forward in Australia (12/28/2011)Painkillers Linked to Birth Defects When Used During Pregnancy: Study (12/15/2011)Tags: Birth Defects, Pomalyst, Thalidomide

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Cefepime and Dextrose Injection Recall Issued Due to Particulate Matter

Published: October 16th, 2013

Particulate matter contamination has led to the recall of one lot of Cefepime and Dextrose injection fluid, due to a potential risk that the injections could cause severe and life threatening health consequences.  

A Cefepime and Dextrose injection fluid recall was announced by the FDA on October 15, after the manufacturer found visible organic particles had entered the fluid during production. No injuries or reports of illnesses have been reported to date.

Cefepime and Dextrose injection is an antibiotic combination used to fight off microorganism infection such as fungus and other strong forms of bacteria.

The recall includes 1g Cefepime for injection USP and Dextrose injection USP with lot number H3A744 and catalog number 3193-11. The affected lot was packaged in a DUPLEX single dose intravenous plastic container with 24 units in each case and has expiration date January 2015.

The injections were manufactured by B. Braun Medical Inc., and distributed to licensed distributors, hospitals, pharmacies, and customers between February 4, 2013 and March 1, 2013.

Use of the contaminated injections may cause several health consequences such as phlebitis, weakened immune systems, and both chronic and acute inflammatory responses. The risk to the consumer is heightened if the debris travels throughout the body posing a risk of inflammation in the lungs, respiratory failure, renal failure, and even strokes if a left cardiac shunt is present.

B. Braun has started to notify all known distributors and customers by mail with a return receipt letter to be filled out and returned along with all remaining product. Customers should stop issuing or taking the affected injection fluid immediately and contact B. Brauns Customer Support Department at 1-800-227-2862 for instructions on how to receive a replacement product.

Related ArticlesSagent Vecuronium Bromide Recall Issued Due to Impurities (6/11/2013)Hospira Injection Recall Issued Due to Particulate Matter (4/29/2013)Gilead Vistide Recall Issued Due to Particulate Matter (2/18/2013)Hospira Recalls Caloric Fluid Due to Mold Contamination (1/29/2013)Particulate Matter Leads to Indomethacin, Sodium Chloride Recalls (6/16/2011)Tags: Antibiotics, Drug Recall, Kidney Failure, Particulate Matter, Respiratory, Stroke

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Using Byetta With Avandia May Negate Heart Attack Risks: Study

Published: October 16th, 2013

Researchers say that the diabetes drug Byetta may help reduce the risk of heart attacks from Avandia, another diabetes drug that has been heavily restricted due to cardiac concerns. The findings suggest that using the drugs in combination may negate the risk of heart problems, and the researchers hope the study may show how possible solutions to drug side effects could be gleaned from FDA data on adverse events.  

The study was published last week in the medical journal Science Translational Medicine, using data from the FDA’s Adverse Event Reporting System (FAERS) to identify a possible link between taking the diabetes drugs Byetta and Avandia together and a reduced risk of heart attack.

Avandia (rosiglitazone) is a GlaxoSmithKline diabetes drug that has been found to increase the risk of heart attacks. Once a blockbuster drug, it is now used by only a few thousand patients, and has been banned in a number of countries. In the U.S. it is only available via a Risk Evaluation and Mitigation Strategy (REMS) designed to restrict its use to lower the chances of patients suffering heart attacks.

Researchers from the Icahn School of Medicine at Mount Sinai, New York analyzed FAERS data and found that patients who were taking Byetta and Avandia together were less likely to suffer a heart attack than those just taking Avandia. They looked into how this could be possible and determined that incretin mimetics, a class of diabetes drugs that includes Byetta, Januvia, Janumet and Victoza, could reduce Avandia’s chances of increasing blood clotting.

The discovery led to the researchers looking for other possible drug combinations that could mitigate adverse events, known as polypharmacology, and they found another 19,133 possible drug combinations that could be studied.

“We conclude that this type of crowdsourced approach of using databases like FAERS can help to identify drugs that could potentially be repurposed for mitigation of serious adverse events,” the researchers stated.

Diabetes Drug Concerns

Since concerns about the heart risks of Avandia surfaced in 2007, confidence in the safety of diabetes drugs has been shaken, with several other medications also being linked to serious side effects.

Although the drug may help mitigate the risk of heart attacks when used with Avandia, recent reports have raised concerns about an increased risk of pancreatic cancer from Byetta and other similar drugs that are part of the incretin mimetic family. Other popular diabetes drugs that have also been linked to a possible risk of pancreatic cancer and pancreatitis include Januvia, Janumet, Victoza and others.

A growing number of Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits are now being filed in courts throughout the U.S. alleging that the manufacturers of the medications failed to properly research the side effects or warn that they increased the risk of pancreatic cancer.

Concerns about the potential side effects of Actos have also emerged in recent years, including indications that users may face an increasd risk of bladder cancer following long-term use of this other popular type 2 diabetes medication. Actos (pioglitazone) is a member of the same class of medications as Avandia, and sales of the drug took off after Avandia use was restricted. However, concerns about the Actos bladder cancer risk began to emerge in 2010, after interim data from an ongoing study found that users may face an increased risk.

About 2,500 former users are now pursuing Actos bladder cancer lawsuits against the drug’s manufacturer, alleging that inadequate warnings were provided about the risks associated with long-term use of the diabetes drug.

Related ArticlesSulphonylurea Diabetes Drugs May Increase Heart Attack Risk: Study (9/19/2013)Actos Side Effects May Raise Bladder Cancer Risk: Study (5/17/2011)Actos Bladder Cancer Risk Being Reviewed by FDA (9/20/2010)Actos Heart Side Effects Similar to Avandia: Study (8/26/2010)Avandia Heart Attack Risk Twice as High as Other Diabetes Drugs: Study (2/9/2010)Tags: Avandia, Byetta, Diabetes, Diabetes Drugs, GlaxoSmithKline, Heart Attack, Janumet, Januvia, Pancreatic Cancer, Victoza

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Craze Performance Fuel Contains Amphetamine-Like Ingredients: Report

Published: October 16th, 2013

A new report indicates that the popular pre-workout supplement Craze “Performance Fuel” contains an amphetamin-like compound that is similar to meth, leading the manufacturer to suspend production.

In a study published this week in the medical journal Drug Testing and Analysis, researchers from Harvard Medical School, NSF International, and The National Institute of Public Health and the Environment in the Netherlands indicated that the Craze bodybuilding supplement tested positive for the compound n-alpha DEPEA, which is chemically similar to methamphetamine and an analog, or chemical cousin, to meth.

Two independent labs tested three samples of the product from three different lots. All tests revealed the same results, a meth-like ingredient was present in Craze.

Researchers call the compound a

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