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Articles Posted in Food & Drug Administration

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On October 29, 2015, the FDA issued a recall of Skippy Peanut Butter, due to the fact that, during production, small pieces of metal may have entered into nearly 2,000 pounds of Skippy Peanut Butter, posing serious injury and/or choking hazards for consumers, many considered children.

The possible error was announced after a routine in-line magnet check discovered small metal fragments had entered the product at some point during the production process. No injuries have been reported or received by the Manufacture or the FDA, to date.

Skippy peanut butter is manufactured by the company Hormel Foods. Hormel Foods voluntarily announced the recall due to the severity of injuries that could occur if consumers ingest peanut butter products with significant sized metal shavings. Any food borne object greater than 7mm in length has the ability to cause injury. Injuries, such as: severe choking, airway obstruction, intestinal perforation and secondary infections.

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Prescription drugs aren’t recalled as frequently as automobiles, but they are recalled every so often. However, it is more difficult to reach the person prescribed the medicine then it is to contact an owner of a vehicle with a recall in place.

The parties responsible for prescription drug recalls are the Food and Drug Administration (FDA) and the manufacturer of the medicine being recalled. The FDA requires that customers be notified, when a recall is issues, but the definition of a customer does not include a patient. A customer can be a pharmacy, physician, insurance company and other medical entity.

The generic prescription drug called Methotrexate was recalled in May 2015 by Mylan (Nasdaq: MYL). The recall of this drug included the injectable form and three others, because of particular matter in it vials. Pieces of glass were found in the vials causing this specific recall. Methotrexate is used to treat cancer and autoimmune diseases like rheumatoid arthritis
Mylan is also recalling three other drugs, Gemcitabine, Carboplatin and Cytarabine.

Therefore; if you or someone you know has taken the injectable form of methotrexate, please take note of the lot number, expiration date and other specifics of the drug and visit the FDA’s website to see if your specific drug has been recalled.

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According to the journal “Addiction”, most smokers that are trying to quit use electronic cigarettes (e-cigs) as their go-to-device for quitting smoking. It was published by the journal that smokers who use e-cigs are 60% more likely to succeed at quitting than those smokers who use the nicotine patch or gum.

In the United States there are at least six million people who smoke electronic cigarettes. The industry is expected to reach $1.5 billion in sales this year alone. In 2013, the total year sale from these e-cigs was $79 million.

Another study included a survey conducted by the Kantar Media Research Firm, which found that 57% of smokers who use a smoking cessation device choose e-cigs, while only 39% choose a drug and 30% choose nicotine gums and patches.

The FDA, however is concerned with the health risks of the use of these e-cig devices to stop smoking because studies have shown that they release formaldehyde and other carcinogens. Therefore; the FDA has issued warning letter to various e-cig manufactures. In these letters it is declared that claiming that electronic cigarettes help people quit smoking is illegal without FDA approval first. The companies have conducted little to no clinical trials and have no evidence to support their claims, therefore; before these companies can call their devices smoking cessation devices, the FDA must evaluate them for safety and effectiveness.

In April 2014, the FDA announced proposed rules to regulate e-cigs. The proposed rules will restrict the sale and purchase of e-cigs to children under the age of 18. Also, manufactures will be required to register their products with the FDA, report ingredients and market the products only after receiving FDA review and approval, and, most importantly the manufacturers cannot claim that the devices can be used to quit smoking, unless they undergo an FDA review first.

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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.

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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.

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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.

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DePuy Hip Implant.jpg
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.

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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

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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.

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Child left in car.jpg
The summer heat is dangerous for children left in cars. The U.S. National Highway Traffic Safety Administration (NHTSA) reports that Hyperthermia, otherwise known as heat stroke, is the leading cause of deaths for children under the age of 14 in non accident vehicle deaths in the United States. An average of 27 deaths from children suffering from hyperthermia, are reported yearly.

Here are a few tips recommended by the NHTSA to keep children safe in cars during the hot summer months:
– Never leave a child in a vehicle alone – Never let a child play unattended in a vehicle – Never leave infants and children under the age of 14 in parked cars. Not even if you leave the windows slightly open, or if the car is on and with the air conditioning on.
– If you see that a child has been left alone in a hot vehicle, do not hesitate and call the police. Even if you see that the child’s face is red, hot, moist, or even extremely dry, no sweating, nauseated or acting strangely. Remove the child from the vehicle and call the police or ambulance for assistance.

These deaths are 100% preventable, if the right steps are followed by parents, caregivers, and the community.