Defective Drug and Medical Device Blog

Common ways to Curb Workplace Drug Risks


Almost 1 in every 6 injured workers uses opioid medications for six months to 1 year or more after their injuries, in some states.

Use of opioids for a long period of time is expensive for injured workers and their employers. There are also some chances that the injured workers misuse opioids and become addicted to it. It can also lead to illegal distribution to others and it is a serious public health issue. Use of opioids for a long period of time can increase the total cost of a workers’ compensation claim.

According to a new research by the Workers Compensation Research Institute, almost 80% of injured workers received at least one opioid prescription. The main problem is that the use of drug testing for these injured workers falls far short of what medical treatment guidelines recommend. Testing is done to identify patients that may be abusing opioid medications.

Decreasing the intake of narcotics that are not necessary in the treatment of injured workers is the job of all stakeholders in the workers’ compensation system in which employers, labor, physicians, hospitals, insurers and public policymakers are included.

The WCRI study, named as Longer-Term Use of Opioids, identified the states where workers were most likely to be using opioids long time after their injury. The study revealed that 1 in 6 injured employees who started using opioids were still using them 3 to 6 months later in Louisiana and New York. Nearly 10% of injured workers received opioids on a longer-term basis in some states in which Pennsylvania, South Carolina, California and North Carolina are included. As compared to other states, Arizona and Wisconsin showed the lowest percentage of injured workers using opioids for a long time; it was 3% and 4% respectively.

From all the injured workers with longer-term use of opioids, nearly 1 in 4 received drug testing, including urine drug testing. Treatment guidelines recommend random drug testing to stop opioid misuse by patients on opioid therapy. Periodic psychological evaluations and treatment to help manage the addictive effects of these powerful drugs are also recommended. In some states, only 4 percent to 7 percent of the injured workers received testing and treatment services. In states where these services are given to more patients, the figures are still low.

The study is based on nearly 300,000 workers’ compensation claims and 1.1 million prescriptions associated with those claims from 21 states. The claims represent injuries arising from 1st of October 2006 to 30th of September 2009, with prescriptions filled up to 31st of March 2011.

Attorney Bradford Horan provides strong and efficient Criminal Defense and DWI Defense in New Hampshire.

Author Bio:

David Horan is a highly successful criminal defense attorney specializing in DWI, armed robbery, theft, battery and domestic violence problems, among other types of cases.

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FDA Warns: Diet Products Contain Dangerous Drugs


Obesity is a growing problem in this county. According to the Centers for Disease Control and Prevention (CDC), 37.5 percent of adults and 17 percent of children and adolescents are obese in this country. Obesity related conditions include heart disease, type 2 diabetes and certain types of cancer.

Along with the rise in obesity comes a rise in diet products promoting weight loss for the obese. There are those over-the-counter products that claim to contain natural ingredients that will safely assist you in losing weight. However, according to the FDA, not all of these products are safe, and, in fact, can be quite dangerous to your health.

The FDA issued warnings on several weight loss products, all claiming to be natural. One product “Fat Zero” claims to be all natural, containing bee pollen, green tea and lotus seed. “Fat Zero” claims on its website it “will give your body the jump start it needs to lose those unwanted pounds.”

According to the FDA, however, this product also contains sibutramine, which is a prescription drug so dangerous it was pulled off the U.S. market. “Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons … the product poses a threat because it is known to substantially increase blood pressure and/or pulse rate in some users and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.”

The FDA also issued warnings on “Fruit & Plant Slimming” and “Extreme Body Slim” as these products both contain sibutramine, as well.

Another product, “Royal Dragon Herbal Tonic Balls” is sold for sexual enhancement and has also been issued a warning by the FDA for containing vardenafil. “This undeclared ingredient may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels,” the FDA cautions.

Unfortunately, diet supplements and herbal products are not regulated by the FDA, and as long as the manufacturers do not make specific health claims, these products can be sold as containing ingredients that are “generally recognized as safe.”

The FDA tests diet supplements and herbal products and if prescription drugs or other dangerous ingredients are found, they will warn the public about the dangers associated with the products.

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Symbios GOPump and GO Block Kits Recalled


The Symbios GOPump Rapid Recovery System is a disposable local pain management system distributed by B. Braun Medical Inc. and manufactured by Symbios Medical Products out of Indianapolis, Indiana.  The GOPump System delivers pain medication slowly to a surgical site through tubes leading from a small balloon that is inflated with a local anesthetic medication.

The Food and Drug Administration (FDA) has issued a Class I recall for the Symbios GoPump in the GoPump Rapid Recovery System Kits and the GoBlock Kits, as well.

The FDA reports those systems manufactured before July 2012 and distributed from April 27, 2011 to April 30, 2013, may have excessively high flow rates.  These high flow rates could result in medications being delivered too quickly from the balloon to the surgical site and could cause patient toxicity because of too much medication in too short of a time.  The patient could then suffer serious illness, including seizure, abnormal heart rhythms and death.  Those most susceptible are patients with a low body mass and the elderly.

When the FDA issues a Class I recall – the most serious type of recall – the agency feels there is a good chance the recalled product could cause serious injury or even death.

The FDA commented that customers who purchased these devices were notified by letter dated May 10, 2013 about the problem, and then again by follow-up letters on May 14th and May 30th, as well.  The FDA directed customers to quarantine the recalled product and to also complete and return a verification form.

B. Braun notified customers on May 14, 2013, and directed them to complete and return the attached “Product Removal Acknowledgement Form.”  Customers who purchased the product from B. Braun Medical, should contact the company at its toll free number.  Those customers who purchased this product directly from Symbios Medical Products should call the company’s toll free number for directions on returning the product and obtaining a refund.

Posted in Medical Device Recall |

FDA Investigation Into Antipsychotic Drug Deaths


Zyprexa Relprevv is an antipsychotic that helps correct chemical imbalances in the brain and is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings, and behavior. This antipsychotic drug is given as an injection into a large muscle in the buttock where it is slowly released over the next two to four weeks.

The Food and Drug Administration (FDA) announced it is investigating two unexplained deaths in patients who received an injection of Zyprexa Relprevv. The two patients died three to four days after receiving an appropriate dose of the antipsychotic drug, which is well past the three hour post injection monitoring period that is required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).

According to the press release, both patients who died from the injection, were found to have very high oanzapine blood levels, which can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced levels of consciousness ranging from sedation to coma.

REMS requires patients to receive injections of Zyprexa at a REMS-certified facility, to be continually monitored for three hours at the facility after injection of the drug, and to be accompanied home from the facility, as well.

A patient can suffer post-injection delirium sedation syndrome (PDSS) should the drug enter his blood too fast after an intramuscular injection, thus the three hour observation requirement after an injection. In clinical trials, PDSS was observed within three hours of injection, but no deaths occurred because of the syndrome.

The FDA is continuing its investigation into the deaths and cautions health care providers to follow the REMS requirements and drug label recommendations, as well.

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Beware of Fraudulent Botox


Botox is one of the names for the neurotoxic protein called botulinum toxin, which in large doses causes botulism, a rare but serious illness caused by bacteria.

Botox currently has many uses, but is most commonly known for its cosmetic use of treating wrinkles, facial creases, lazy eye, uncontrolled blinking, and glabellar lines.  Botox in 2012 generated sales of $1.77 billion, with approximately half coming from cosmetic use.

Non-cosmetic uses for Botox are treatments for cervical dystonia, writer’s cramp, excessive sweating, achalasia, chronic pain, neuropathy, migraine headaches and overactive bladders.

Unfortunately for the many users of Botox in this country, the U.S. Food and Drug Administration reported last month that fraudulent versions of Botox are being sold in this county.  The FDA posted an alert on its website stating the outer carton of the fraudulent Botox is counterfeit, and it contains a foreign vial inside which is not approved for sale in the United States.

In a press release, the FDA said, “The FDA cannot confirm that the manufacture, quality, storage and handling of these products follow U.S. Standards.”

The Botox that has been approved in this country is made by Allergan Inc..  Allergan warned those healthcare professionals that were purchasing products from a non-Allergan supplier, that these products are illegally imported and may either be counterfeit or the quality may have been compromised, as well.

In 2004, four people were injected with unapproved botulinum toxin and required hospitalization.  In a wide scale investigation of more than 200 clinics throughout this country, dozens of people were convicted for injecting patients with unapproved, cheaper substitutes of Botox.

To prevent the use of counterfeit or contaminated products in this country, our elected officials in Washington are seeking to create a set of standards to be used nationally for tracking prescription drugs and medical products such as Botox through the distribution chain.

To read the FDA’s alert on Botox, go to the agency’s website:

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‘Magic Bullet’ Development Could Treat Acute Lung Injury


A study conducted through Queen’s University has developed a drug described as a ‘magic bullet’ to be used in the treatment of lung injury. The drug’s success could potentially become the first treatment of its kind to be used in intensive care cares.

While the news is encouraging, reports also indicate the findings are potentially three years away from becoming clinically evaluated. The findings from University scientists pertain to the discovery of a certain particle able to bind to specific blood cells in relation to lung damage.

The ‘magic bullet’ itself is a new drug referred to as a nanoparticle. The smaller structure literally enables patients the ease of inhaling it, sending the drug directly to the source of inflammation in the lungs. Its development is a noteworthy step toward finding a solution for Acute Lung Injury (ALI).

After the patient afflicted with ALI inhales the nanoparticle, the drug latches on to specific cells in the lungs and rapidly reduces the inflammation. As the drug continues its own development, it may similarly be utilized in cases of Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis, disorders classified throughout the lungs.

Posted in Drug Studies |

Class I Recall Issued for GE Healthcare Incubators


GE Healthcare designed two products – the Giraffe OmniBed and the Giraffe Incubator – to provide thermal and developmental care to newborn babies.  These products are used to maintain the body temperature and, in some models, the oxygen level of newborn babies.

The Giraffe OmniBed can function in either the closed mode as an incubator or in the open mode as a warmer, and can transition from one mode to another depending upon the user’s demand.  The Giraffe Incubator provides heat through a closed, temperature-controlled environment that maintains the body temperature of a newborn infant, with some models containing a  controlled oxygen delivery system that can be used to provide oxygen to newborn babies, as well.

The Food and Drug Administration (FDA) issued a Class I Recall in April for certain models of GE’s Giraffe OmniBed and Giraffe Incubators manufactured and distributed between August 2012 to December 2012.  Those models being recalled may, when recovering from a power failure, delete stored information and then enter new erroneous information in its place.  Should this occur, the heater or oxygen delivery option is turned off, the new set point will be “0”, and alarms may fail to alert healthcare personnel that either the heater or oxygen delivery options are “off” or that  set points are lower than intended.

Egypt’s incubator shortage: A medical tragedy

Any newborn baby using these devices during a power outage may suffer serious adverse health consequences, including death, due to this malfunction.  Adverse health consequences include inaccurate body temperature, which can result in either hypothermia (dangerously low body temperature) or hyperthermia (dangerously high body temperature), and inaccurate oxygen regulation, which can result in hypoxia (low blood oxygen) or hyperoxia (high blood oxygen).

GE Healthcare will correct all affected devices at no cost to customers and urges all healthcare professionals to report any adverse reactions related to use of the Giraffe OmniBed and/or Giraffe Incubator to the FDA’s MedWatch Safety Information and Adverse Reporting Program online or by calling their toll free number: 1-800-332-1088.

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New Drug-Induced Liver Injury Study Released


A recent case and literature review reveals that drug-induced liver injury, typically in the form of acute hepatocellular injury with autoimmune features, could potentially be class effect of tumor necrosis factor-alpha antagonists.

Researchers worked among six different cases of drug-induced liver injury (DILI) that related to tumor necrosis factor-alpha (TFN-a) antagonists, the cases gathered from the US DILI Network (DILIN) database. All cases arose through 2003 – 2011. An additional 28 reported cases were gathered through literature review of the PubMed database specifically for studies that observed TNF-a antagonist-related hepatotoxicity.

According to researcher Maurizio Bonacini, MD, it was decided to include literature cases in an effort to establish the most prevalent cases of anti-TNF toxicity. Of the 26 cases that researchers at Infliximab studied, four cases were considered relatable to adalimumab and etanercept.

The DILIN probability scale indicates the drug was a determined cause for injury throughout at least one case, proving “very likely” in an additional 21 cases and “probable” throughout the remaining 12 cases. The average latency throughout each case measured 13 weeks.

It was later reported that no patients involved in the study died as a result of their injuries, with only one patient showing no improvement following discontinued use of the drug.

Posted in Drug Studies | Tagged |

New Drug May Help Asthmatics


A new asthma drug being developed by Sanofi and Regeneron Pharmaceuticals, Dupilumab, appears to help those asthma patients whose condition does not respond well to existing medicines.

The results of a small clinical trial – 12 weeks – was published online in The New England Journal of Medicine and was presented at the American Thoracic Society’s annual meeting in Philadelphia.

The 12-week study  involved 104 asthma patients whose disease was not well controlled by their existing medications and who also had elevated levels of a type of immune system cell associated with problematic asthma.  Those patients in the study who took Dupilumab saw both the number of asthma attacks or other outbreaks of symptoms decrease by 87 percent when compared with those receiving a placebo.  The study results also showed those patients taking Dupilumab had improved measures of lung function and disease control, as well.

Dupilumab works by blocking the action of interleukin-4 and interleukin-13, two inflammatory chemicals made by the body which are believed to contribute to asthma.

In America, about 25 million people have asthma.  It is estimated that about 10-20 percent of those Americans having asthma cannot control the disease by common therapy – inhaled steroids and long-acting beta agonists.

The New England Journal of Medicine also published a commentary on the asthma study.  The commentary stated it was “too early to tell if this therapy will be of clinical value,” though it was probably “on the right path,” and much” larger studies taking at least two years will be needed before Dupilumab could reach the market.”

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California to cut off funding for database that monitors prescription drug usage


By the end of this year, the state’s prescription drug monitoring program may run out of money. California is about to stop funding for a database that monitors prescription drug use and abuse, unless people like Robert Pack can convince state lawmakers that the program is very important.

On Monday, before the hearing on a bill that would increase funding for CURES, Pack told that “I lost my 10-year-old son Troy and my 7-year-old daughter Alana to a doctor shopper”. 9 years ago, Pack was walking with his family in their Danville neighborhood when a woman driving 45 miles-an-hour hit and killed 2 of his kids. After the incident, Pack came to know that physicians at Kaiser Permanente had given her thousands of prescriptions. “She had received 315 Vicodin, 180 Flexeril muscle relaxants — and took them all prior to that accident”.

Controlled Substance Utilization Review and Evaluation System (CURES) requires pharmacists to report any prescriptions of controlled substances to the state Department of Justice. Law enforcement uses this program for monitoring the prescritions of doctors suspected of giving too many addictive pain medications. Doctors also query the database to determine whether patients are “doctor shopping,” or seeking potent drugs from different sources to feed an addiction. The data is also used by the Special Justice Department agents for signs of criminal use of prescription drugs.

On Monday, Attorney General Kamala Harris said, “We can’t let any more time pass on this. We need to fund this. Each day matters, and each day someone is out there abusing drugs or a physician is abusing the rights of their license and they need to be caught.” He is sponsoring SB 809 to modernize CURES. This bill increases fees on prescribing professionals and taxes drug manufacturers for increasing the necessary $6 million a year.

CMA board member Dr. Bob Wailes said, “Before I prescribe a potent narcotic on a new patient I would always want to see what their prescription history was. If they’re addicted to medicine we want to know about it. If they’re diverting the medicines to other people and selling, we need to be aware of that so we don’t keep giving them prescriptions”. According to him, any legislation to boost the funding for CURES should also make it easier for doctors to participate.

SB809 is opposed by the California Retailers Association.

Before filling a prescription, the legislation would require its members to consult the CURES database.

Association president Bill Dombrowski said, “The actual program as it exists today has been so poorly funded; it’s really not practical for our usage”. According to him, it can take 6 weeks for CURES database managers to answer an email query. No one’s going to want to wait that long for a prescription. He said, “Let’s talk after you get it working about how we can use it and participate in it. But let’s not put in a statute that says we have to participate in something that isn’t even fixed yet”.

Lawmakers passed the measure by 7-2. On 1st of July, funding for the CURES database will run out if the bill fails.

Author Bio:

San Francisco DUI attorney – Aaron Bortel is a member of California and national DUI associations, and for over 18 years, people have trusted his skill & judgment. Has a massive experience of handling DUI cases in California.

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