Recently in Food and Drug Administration Category

October 29, 2013

Vicodin to be Reclassified as a Schedule II Drug by the FDA, HHS and DEA

The Food and Drug Administration (FDA) has decided to place new limits and regulations on the painkiller Vicodin. Vicodin is generically known as Hydrocodone. The new limits and regulations on the drug will come as a result of it being reclassified as a Schedule II drug. A Schedule II drug is considered to be more powerful and has a higher risk for potential drug abuse and addiction. This reclassification will limit how many Hydrocodone-based pills a doctor or medical provider can prescribe to any one patient and would require stricter storage and handling requirements.

With the reclassification, the goal is to prevent theft and abuse of these pills, which is considered to be the number one way federal regulators are trying to fight against the current painkiller abuse epidemic in the United States. The reclassification of Hydrocodone drugs would require fewer prescriptions be written at any one time and to any one patient and would prohibit patients from receiving more than a three month supply at one time.

Opioid painkillers, such as Hydrocodone, have been responsible for more deaths than cocaine and heroin combined since 2003. It is the misuse and accidental overdoses caused by the use of these drugs that are causing so many deaths in the United States. In 2007 alone, there were about 27,000 unintentional prescription drug overdose deaths reported in the U.S.. As of 2008, the CDC reported that prescription drug overdoses have accounted for more deaths than traffic accidents.

Therefore, the FDA will submit a formal recommendation package to the U.S. Department of Health and Human Services (HHS) by the end of December of 2013. The HHS oversees any and all FDA topics, discussions and established regulations. Once the HHS makes a decision, it will begin the process that will lead to a final decision by the DEA on the appropriate scheduling of Hydrocodone and Vicodin products.

September 23, 2013

Unique Medical Device Identification System Passed in September in the U.S.

The Food and Drug Administration (FDA) announced on September 20, 2013 that the final rule for a Unique Device Identification system (UDI) has passed. The system is designed to allow the FDA to track medical devices and help raise warning flags about problems that may exist with a particular model. It is designed to identify potentially dangerous and defective medical devices in the United States, such devices as hip replacements and knee replacements.

The UDI will have two parts. One part is that it will have an identification number that will be assigned to each medical device, which will enable quick identification of the lot number, expiration date and manufacturing date for each medical device. The second part will be a database that is searchable by the public, called the Global Unique Device Identification Database (GUDID). The database will not have patient identification information, however; it will only be used as a reference catalogue for every medical device with a unique device identifier number. This will allow patients and the medical community to see for themselves; whether the specific medical device appears to be linked to failures and other problems.

The new way to identify medical devices will result in more reliable date on how medical devices are used. In turn, this can promote safe device use by medical providers and patients. It will also allow for faster, more innovative and less costly medical device development.

March 13, 2013

The Antibiotic Zithromax May Cause Fatal Heart Problems

The FDA has issued a warning for the antibiotic drug Zithromax, commonly known as Z-pack or Zmax, due to the fact that the drug can cause disruption to the electrical activity of the heart. An investigation has been conducted since May 2012 to determine the side effects of Zithromax and therefore a warning was issued on Tuesday, March 12, 2013.

Zithromax is an antibacterial drug known as macrolides, which have been known to cause abnormal heart rhythm problems, which can lead to fatal heart conditions. In the research conducted by the New England Journal of Medicine, it was found that patients who took Zithromax were 2.5 times more likely to die due to heart related problems on a 5 day treatment plan when compared to patients using other antibiotics.

Patients with existing medical conditions were at higher risk of heart health issues as those without pre-existing medical conditions. Patients with low blood levels of potassium and/or magnesium, those with slower than normal heart rates and those taking certain drugs used to treat abnormal heart rhythms were at higher risk of complications when using Zithromax.

Pfizer, in 2011, made a profit of over $450 million in Zithromax sales. The drug is usually prescribed to patients suffering from urinary tract infections, tonsillitis and other bacterial infections. Patients should consult with their physicians before taking this drug and doctors should inform patients of the possible heart problem drug side effects of using this drug.

February 7, 2013

DePuy ASR Hip Implant Recall

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Over 10,000 lawsuits have been filed against the company Johnson & Johnson for their distribution of the DePuy ASR hip implant, since a recall was issued in August 2010. The DePuy ASR hip implant has a metal on metal design, which means that a metal head rotates within a metal cup. This design causes metal debris, caused from the metal parts rubbing against each other, to be released into the surrounding tissue and cause medical problems. The failure occurs within five years of replacement.

When the recall was first issued, Johnson & Johnson stated that the failure rate was only about 13%, but after documents were released as part of the litigation, it was estimated that the failure rate of the DePuy ASR hip implant is as high as 37%. This means that one out of every eight DePuy ASR hip implants were failing within five years of replacement surgery.

There is currently a case going on in California against Johnson & Johnson for the marketing, manufacturing and sale of the defective DePuy ASR hip implants. It is being said that the company failed to properly warn the public, as well as healthcare professionals, about the risk of loosening and other complications that may develop shortly after hip replacement surgery.

In testimony in the current case being heard in California, a DePuy engineer testified that Johnson & Johnson only tested one angle of implantation and that the company failed to use the right engineering controls when trying to assess potential problems. The engineer further stated that the testing conducted failed to predict how much wear the hip implants would experience and how much they could loosen.

The FDA released a new guidance for metal on metal hip replacements in January of this year. Doctors were advised that metal on metal hip replacement systems should only be used if other artificial hip implants were not appropriate for the patient, and called on all manufacturers to prove that their implants are safe enough to stay on the market. Also, future metal on metal hip designs will have to undergo extensive human clinical trials before being made available for sale to the public.

September 28, 2011

Serious Side Effects of Levaquin Reported in the U.S.

The popular antibiotic Levaquin, is available only by prescription, comes in tablet, oral solution and intravenous forms and is prescribed to adults, over the age of 18, to treat infections. These infections include: sinus infections (sinusitis), chronic bronchitis, pneumonia, skin infections or skin-structure infections and various types of urinary track infections.

Levaquin should only be taken by prescription and one must follow physician orders. If taken incorrectly or in high dosages it can have severe side effects and even death. Levaquin has also been associated with an increased risk of tendon rupture or swelling of the tendon (tendinitis). The risk, however, is higher in adults over the age of 60, people who take steroids, and those who have had kidney, heart of lung transplants.

If you experience any weakening of muscles, tendons or any swelling and/or inflammation, please seek medical help immediately. Tendon rupture can occur while you are taking Levaquin or even months after you stop taking it.

Other possible side effects of Levaquin include: liver damage, central nervous system side effects (such as: seizures, hallucinations, confusion, anxiety, difficulty sleeping, etc.), allergic reactions, damage to the nerves in arms, legs and hands, intestinal infections, changes in heart rhythms and changes in blood sugar.

The most common side effects of Levaquin include: nausea, headache, diarrhea, constipation and dizziness. While taking Levaquin you should avoid sunlaps/tanning beds and operating heavy machinery.

In 1996, the Food and Drug Administration (FDA) approved the distribution of Levaquin and in 2008 it required that the drug packaging have a black box warning label. The black box warning label is the strongest warning that can be placed on a prescription medication.

Currently, in the United States, there are about 1,900 Levaquin tendon damage cases pending litigation.

For a complete list of symptoms and side effects you may contact your physician and the FDA by visiting www.fda.gov/medwatch, or by calling 1(800)FDA-1088

September 20, 2011

Listeria Outbreak Reported in 17 States Due to Rocky Ford Cantaloupes

Listeria-Cantaloup.jpgThe Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) Issued a Rocky Ford Cantaloupe recall on September 14, 2011, following an investigation, due to reports of listeriosis outbreaks that have so far made 22 people in seven states sick. Nine other outbreaks of listeriosis were also reported in New Mexico, of which three resulted in deaths.

The recall was issued in 17 states in connection with this listeria food poisoning outbreak. Listeria infections, also known as listeriosis, pose risks for children, the elderly and those with weak immune systems. For pregnant women, it can cause miscarriages and still births. The fatality rate is about 25%. Listeria can however be treated with antibiotics, once it is diagnosed through blood testing. Symptoms include: muscle aches, abdominal pain, nausea, diarrhea, sever headaches and fever. If the infection spreads to other organs or even in the bloodstream it could cause meningitis and other health complications. Therefore, it is important that you get the necessary blood work done to determine whether what you are experiencing is listeriosis or not.

This Jensen Farms Rocky Ford Cantaloupe Recall affects the following states: Illinois, Wyoming, Tennessee, Utah, Texas, Colorado, Minnesota, Kansas, New Mexico, North Carolina, Missouri, Nebraska, Oklahoma, Arizona, New Jersey, New York and Pennsylvania.

If you have any further questions or concerns, please contact the FDA, the CDC and your local state health department.

July 19, 2011

BPA Exposure can Affect the Human Endocrine System

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The Environmental Health Perspective published a study on the effects that many plastic additives have on the human body, the endocrine system and thyroid levels to be exact. Bisphenol- A (BPA) is an additive used in plastic products to harden and make them shatterproof, that has been shown to lower thyroid levels in human beings and has been linked to cancer, heart disease, diabetes and obesity. BPA and other types of plasticizer are most commonly used in food processing and packaging, as well as bottles, cups, can liners, baby products and various other types of food containers. It is the chemical in BPA and other phthalates that can affect the human endocrine system and cause developmental problems.

1,700 adults and teenagers were studied and it was determined that the higher the rate of Food and Drug Administration (FDA) has recommended that parents reduce the amount of exposure to BPA and other Phthalates to their children. The FDA is currently investigating and re-evaluating the previously established safety regulations of BPA. The re-evaluation began in June of 2009 and is still currently underway. Until the re-evaluation is completed, parents and all adults are recommended to reduce their exposure to BPA and other Phthalates in order to reduce health problems to their endocrine system.

July 12, 2011

Basis for Product Liability Legal Claims

When consumers make purchases they expect them to function properly and safely. It is when the purchased defective item causes injuries and illnesses that there are basis for product liability lawsuits. Some of these items are: automobiles, prescription drugs, beauty products, frozen foods, automobile parts and tires, etc.

When Manufactures realize that a product is defective they issue out a recall of that item to consumers. However, recalls do not always keep the consumer safe.

Product liability claims are based on the theory of negligence. The manufacturer has a duty to exercise a reasonable standard of care for developing a particular product, and has failed to do so; thus resulting in harm to the consumer. When making a negligence claim, the injured consumer must prove that the defective product was the actual and proximate cause of the injury. One must show that had it not been for the defective product, the injury would not have occurred. The manufacturer should have foreseen the danger and risk when it sold the product.

Design defect, failure to warn/improper labeling and manufacturing defects are the most common scenarios that form the basis for a product liability claim.

Product liability claims can also be based on the following legal theories:
- Breach of Warranty - failure to fulfill terms of a promise or claim made regarding the quality and safety of a product. A manufacturer must guarantee certain warranties on products sold and needs to be held accountable when they are breached;

- Strict Liability - responsibility of the manufacturer to all consumers who might be injured by a product and does not require the injured consumer to prove negligence. The consumer only needs to prove that the product was defective and therefore cause the injury, therefore; making the product unreasonable defective and dangerous. The designer, manufacturer, distributor and seller of the defective product can and should be held liable for the injury and illnesses cause to the consumer.

- Misrepresentation - when a manufacturer gives the consumer false or misleading information on the safety and reliance of a product. When the consumer relies on this information and is harmed, they can recover money damages.

A consumer can also contact the Consumer Product Safety Commission for further details and advice.

May 17, 2011

To Prevent Hospital Infections the FDA is Proposing New Guidelines For Cleaning Medical Devices

Endoscopes.bmpThe U.S. Food and Drug Administration (FDA) is proposing new guidelines for the cleaning of reusable medical equipment, which if not done properly, can cause infections at hospitals and other medical facilities and doctors offices.

The new guidelines would require manufacturers to provide detailed instructions on how to clean any medical device that will be reused on multiple patients, properly. The guidelines would also provide cleaning instructions of those devices for health care professionals.

These guidelines are being implemented because when these instruments are not cleaned and/or sterilized properly, they could carry bodily fluids and other materials from one patient to the next and therefore; cause infections. These infections can be life threatening and should be avoided, and with these new guidelines, they could potentially be avoided.

A report released by the FDA, from January 2007 to May 2010, they received 80 reports of inadequate cleaning of endoscopes and 28 reports of hospital acquired infections that were most likely spread by endoscopes. Endoscopes are small cameras that are inserted into the body. They are most commonly used in colonoscopy procedures, but can also be used on ears, nose and throat procedures.

The FDA has a public workshop scheduled for June 8 and 9th of this year, to discuss the draft guidelines with manufacturers, health care providers and other government agencies, after which, the FDA would draft a final guidance. Guidance are recommended procedures that are recognized as federal standards.


January 28, 2011

Pharmaceutical Companies Are Responsible for the Most Federal Fraud Lawsuits Filed in the U.S.

Q: What Industry do you think is the leader in Federal Fraud Lawsuits in the United States?
A: Pharmaceutical Industries.


Photo credit: mconnors from morguefile.com

According to a report released by False Claims Act comes from pharmaceutical companies. The report shows that Drug Companies are the leader in Federal Fraud Lawsuits. Defense Companies accounted for 11% of fraud settlements, this makes them the second highest in federal fraud lawsuits, in the United States.

Public Citizen was founded in 1971 and serves as the people's voice in the nations capital. It is a nonprofit organization responsible for being the voice of many in all aspects of the government. They go before Congress, the executive branch agencies and the court systems. They challenge various agencies, such as pharmaceutical, nuclear and automotive industries.

The report analyzed civil and criminal settlements under the False Claims Act at the state and federal levels since 1991 in order to determine the leaders in federal fraud suits.

The False Claims Act is a law that allows people who are not affiliated with the government to file actions against federal contractors they accuse of committing claims fraud against the government. People who file under the Act stand to receive a portion of any recovered damages. This act provides a legal tool to counteract fraudulent billings turned in to the federal government. The original False Claims Act was passed in 1863 and it has since been revised. The last revision was in 1986 and since then almost $22 billion has been recovered by the federal government.

Out of the almost $22 billion recovered since 1986, 75% of the money and 73% of the cases happened in the last 5 years. The U.S. Department of Justice (DOJ) files most of these fraud cases that are brought against the pharmaceutical companies. Most of these cases are for attempting to market medications that have not yet been approved by the U.S. Food and Drug Administration (FDA). It is illegal under federal drug regulations for a company to promote their products that have not been approved by the FDA.

In 2009, Pfizer was fined $1.2 billion for illegally marketing the painkiller Bextra. This is currently the largest criminal fraud fine in history. The second highest was Elan Pharmaceuticals. It was fined $203 million for illegally marketing the epilepsy drug Zonegram.

April 12, 2010

Prescription Drug Poisoning Has Surpassed Automobile Accidents As the Leading Cause of Unintentional Injury Deaths

Rx bottle.jpgIn a report by the American Journal of Preventative Medicine, prescription drug poisoning now surpasses automobile accidents as the leading cause of unintentional injury death among people of ages 35 to 54.

Currently the number of people that are hospitalized due to overdoses from prescription drugs is 65% higher than they were between 1999 and 2006. Such drugs are OxyContin, Fentanyl and Morphine. The use of these drugs, whether illegally or as a suicide attempt rose 130% and accidental overdoses rose by 37%. No other prescription drug causes such a high occurrence of hospitalizations in the United States, according to Researchers from the West Virginia University School of Medicine.

Overdoses from drugs such as tranquilizers, sedatives and painkillers, has also risen by 65% in the last couple of years, making drug poisoning the second leading cause of unintentional injury death in the U.S.

In 2009, an average of 71,000 people, were hospitalized for painkiller overdoses. This is a huge increase from the 43,000 people that were hospitalized in 2008. Methadone is the drug that saw the largest increase in poisoning hospitalizations. Among other drugs that saw an increase in hospitalization is Valium, which saw a 39% increase. Barbiturates and antidepressants actually saw a decrease.

It is due to these huge increases in drug overdoses that caused the Food and Drug Administration (FDA) to approve a new tamper-resistant version of OxyContin. This new version of the drug is supposed to resist the efforts to cut, chew, or crush the pills in order to defeat the slow medication release design of the pills.

April 7, 2010

Human Factors Experts Testimony in Product Liability Cases Is On the Rise

The Food and Drug Administration (FDA) has regulations, guidance documents and industry standards in relation to the use of human factors experts, which allow for more effective cross-examination and a strong defense in Product Liability Cases. With these regulations, human factors not only base their expert opinion on speculation, but also on facts.

You may be asking yourself, what are Human Factors, well it is the study of the relationships between humans, the tools they use, and the environment in which they live and work.

It is with these tools that human factors experts are allowed to testify in cases to provide opinions regarding the adequacy and efficacy of warnings and/or the impact of human factors in the design of products. The Expert must be able to identify a reliable scientific basis for his/her opinion to be used as testimony. It is the goal of the human factors professional to eliminate user error through proper product design and labeling.

Medical devices that are designed by the FDA are designed with the human factor principles in mind. According to the FDA manufacturers must use the following three device classes/guidelines when manufacturing a device for human use:

- The Manufacturer must consider human factors in the development of the device. Such things as what the user sees, feels and hears;
- The Manufacturer must test all devices for the potential in error use by the user;
- The Manufacturer, when conducting risk analysis of the device, must consider user error.

These three device classes must all be subject to good manufacturing practices (GMPs) and these can be found in its Quality System Regulations. It is imperative that the medical device withstand the actions and inactions of its intended user, in order to design an error-tolerant medical device. It is important that the developer consider the characteristics of the worst case user. It is this underlying philosophy that human factor experts are used for.

These Human Factors Principles are also embraced by the Association for the Advancement of Medical Instruments (AAMI), the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO)

April 1, 2010

The Food and Drug Administration Ignored CT Scan Radiation Warnings

CT scan.jpgIn Gaithersburg, Maryland today there will be a two day public hearing to discuss allegations that the FDA ignored some Scientists warnings on the risks of radiation exposure from CT scans that have lead to unnecessary and unexpected health problems and dangers to some patients.

The public hearing will focus on reducing the risks of unnecessary radiation exposure. The concerns about radiation exposure risks came about late last year in Los Angeles, California, when over 200 patients were subjected to radiation overexposure at Cedars-Sinai Medical Center. It was uncovered by the FDA that various cases at other area hospitals were discovered. These discoveries by the FDA lead to a new radiation exposure reduction initiative that was announced in February of this year.

This new initiative seeks to reduce the risk of radiation exposure from medical procedures by promoting the safer use of all medical devices that use radiation, and by providing support to patients in order to better inform them on the risks and side effects to radiation exposure. With this knowledge, patients will be able to make better decisions in regards to their medical procedures and be aware of their total radiation exposure.

The FDA issued a statement in December 2009 that better describes the side effects of radiation and the proper use of medical devices to health care professionals and radiologists. This guidance advised health care providers to review procedures and CT scan settings, and to thoroughly inspect the amount of dosage prescribed for each CT scan patient.