Saturday, December 29, 2018

Another Case Of Polio-Like Disease, Acute Flaccid Myelitis, 3rd So Far, Confirmed In Massachusetts.

According to the Massachusetts Department of Public Health, the number of confirmed cases of acute flaccid myelitis, a rare polio-like disease, has increased by one in Massachusetts while cases under investigation have increased by two.  There are now "3 confirmed, 1 probable and 5 suspect cases of AFM in Massachusetts."
The Centers for Disease Control and Prevention has posted a map showing as of Dec. 21 which states have confirmed cases to date this year of the polio-like disease acute flaccid myelitis.
A Map of acute flaccid myelitis spread.

A map showing as of Dec. 21 which states have confirmed cases to date this year by The Centers for Disease Control and Prevention.
CDC Information

Potential Measles Exposure At Newark Liberty International Airport On December 24th 2018.

In addition to the ongoing measles outbreak in Ocean County, which includes 30 Ocean County cases and 3 Passaic County cases, there is a possible new out break/exposure.
On Dec. 24, 2018, an international traveler who has been confirmed to have measles — a highly contagious disease — arrived in Terminal B at Newark Liberty International Airport on a flight from Brussels. The individual was infectious on that day and may have traveled to other areas of the airport. If you were in the airport on Dec. 24 between 12 p.m. and 4 p.m., you may have been exposed to measles and, if infected, could develop symptoms as late as Jan. 14.
New Jersey residents identified as potentially exposed on the ill individual’s flights will be notified by their local health department.
Anyone who suspects an exposure is urged to call a health care provider before going to a medical office or emergency department. Special arrangements can be made for evaluation while also protecting other patients and medical staff from possible infection.

 

Public Health Alert: Potential Measles Exposure at Newark Liberty International Airport

Contact A Health Care Provider If You Suspect Exposure
On Dec. 24, 2018, an international traveler who has been confirmed to have measles — a highly contagious disease — arrived in Terminal B at Newark Liberty International Airport on a flight from Brussels. The individual was infectious on that day and may have traveled to other areas of the airport. If you were in the airport on Dec. 24 between 12 p.m. and 4 p.m., you may have been exposed to measles and, if infected, could develop symptoms as late as Jan. 14.
New Jersey residents identified as potentially exposed on the ill individual’s flights will be notified by their local health department.
Anyone who suspects an exposure is urged to call a health care provider before going to a medical office or emergency department. Special arrangements can be made for evaluation while also protecting other patients and medical staff from possible infection.
“This confirmed case and exposure are unrelated to the ongoing measles outbreak in Ocean County, which includes 30 Ocean County cases and 3 Passaic County cases,” said New Jersey Health Commissioner Dr. Shereef Elnahal.  “Two doses of measles vaccine are about 97 percent effective in preventing measles, so I urge all residents across the state to get vaccinated to protect their health.”
Measles symptoms include rash, high fever, cough, runny nose and red, watery eyes. It can cause serious complications such as pneumonia and encephalitis (swelling of the brain). Measles infection in a pregnant woman can lead to miscarriage, premature birth or a low-birth-weight baby. Measles is easily spread through the air when someone coughs or sneezes. People can also get sick when they come in contact with mucus or saliva from an infected person.
“Anyone who has not been vaccinated or has not had measles is at risk if they are exposed,” said Dr. Christina Tan, state epidemiologist. “We urge everyone to check to make sure they and their family members are up-to-date on measles/mumps/rubella (MMR) vaccine and all other age-appropriate immunizations.
“Getting vaccinated not only protects you, it protects others around you who are too young to get the vaccine or can’t receive it for medical reasons. If you’re planning an international trip, the World Health Organization recommends that adults or adolescents unsure of their immune status get a dose of measles vaccine before traveling,” Dr. Tan added.
A document with information on what to do if you’ve been exposed to measles is available on our website
For more information about measles, contact your health care provider, or visit our website
The U.S. Centers for Disease Control and Prevention’s website has additional information
Follow New Jersey Health Commissioner Elnahal on Twitter.
Follow the New Jersey Department of Health on Twitter @njdeptofhealth, Facebook /njdeptofhealth, Instagram @njdeptofhealth and Snapchat @njdoh.

Wednesday, December 26, 2018

Safe Minimum Cooking Temperatures For Food Preperation With Rest Times, Including Leftovers.

Safe Minimum Cooking Temperatures

Use this chart and a food thermometer to ensure that meat, poultry, seafood, and other cooked foods reach a safe minimum internal temperature.
Remember, you can’t tell whether meat is safely cooked by looking at it. Any cooked, uncured red meats – including pork – can be pink, even when the meat has reached a safe internal temperature. 

Why the Rest Time is Important

After you remove meat from a grill, oven, or other heat source, allow it to rest for the specified amount of time. During the rest time, its temperature remains constant or continues to rise, which destroys harmful germs.
CategoryFoodTemperature (°F) Rest Time 
Ground Meat & Meat MixturesBeef, Pork, Veal, Lamb160None
Turkey, Chicken165None
Fresh Beef, Veal, LambSteaks, roasts, chops1453 minutes
PoultryChicken & Turkey, whole165None
Poultry breasts, roasts165None
Poultry thighs, legs, wings165None
Duck & Goose165None
Stuffing (cooked alone or in bird)165None
Pork and HamFresh pork1453 minutes
Fresh ham (raw)1453 minutes
Precooked ham (to reheat)140None
Eggs & Egg DishesEggsCook until yolk and white are firmNone
Egg dishes160None
Leftovers & CasserolesLeftovers165None
Casseroles165None
SeafoodFin Fish145 or cook until flesh is opaque and separates easily with a fork.None
Shrimp, lobster, and crabsCook until flesh is pearly and opaque.None
Clams, oysters, and musselsCook until shells open during cooking.None
ScallopsCook until flesh is milky white or opaque and firm.None

Tuesday, December 25, 2018

Statement from FDA On The Agriculture Improvement Act (Farm Bill) And FDA's Regulation Of Cannabis Related Products.

Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.
Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.
We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD). This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act. To help members of the public understand how the FDA’s requirements apply to these products, the FDA has maintained a webpage with answers to frequently asked questions, which we intend to update moving forward to address questions regarding the Agriculture Improvement Act and regulation of these products generally.
In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We’ll also continue to closely scrutinize products that could pose risks to consumers. Where we believe consumers are being put at risk, the FDA will warn consumers and take enforcement actions.
In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.
We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.
These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.
In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.
It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe(GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.
Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.
We’ll use this meeting to gather additional input relevant to th e lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.
At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approves Elzonris (tagraxofusp-erzs) infusion, First Treatment For Rare Blood Disease, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

ELZONRIS(tagraxofusp-erzs; SL-401)
Stemline Therapeutics, Inc. (NASDAQ: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of ELZONRIS(tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.
"Today's approval of tagraxofusp is a major step forward for people with BPDCN, their families and the medical community. CD123 is expressed in BPDCN and a number of other hematologic malignancies. The approval of tagraxofusp, a CD123-targeted therapy, represents a new standard of care for patients with BPDCN." said Naveen Pemmaraju, M.D., Associate Professor at The University of Texas MD Anderson Cancer Center, and a principal investigator on the tagraxofusp clinical trial. " said Naveen Pemmaraju, M.D., Associate Professor at The University of Texas MD Anderson Cancer Center, and a principal investigator on the tagraxofusp clinical trial. 

In the same tone, FDA also lauded the approval, “Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

FDA Release

The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia. The disease is more common in men than women and in patients 60 years and older.
The efficacy of Elzonris was studied in two cohorts of patients in a single-arm clinical trial. The first trial cohort enrolled 13 patients with untreated BPDCN, and seven patients (54%) achieved complete remission (CR) or CR with a skin abnormality not indicative of active disease (CRc). The second cohort included 15 patients with relapsed or refractory BPDCN. One patient achieved CR and one patient achieved CRc.
Common side effects reported by patients in clinical trials were capillary leak syndrome (fluid and proteins leaking out of tiny blood vessels into surrounding tissues), nausea, fatigue, swelling of legs and hands (peripheral edema), fever (pyrexia), chills and weight increase. Most common laboratory abnormalities were decreases in lymphocytes, albumin, platelets, hemoglobin and calcium, and increases in glucose and liver enzymes (ALT and AST). Health care providers are advised to monitor liver enzyme levels and for signs of intolerance to the infusion. Women who are pregnant or breastfeeding should not take Elzonris because it may cause harm to a developing fetus or newborn baby.
The labeling for Elzonris contains a Boxed Warning to alert health care professionals and patients about the increased risk of capillary leak syndrome which may be life-threatening or fatal to patients in treatment.
The FDA granted this application Breakthrough Therapy and Priority Review designation. Elzonris also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted the approval of Elzonris to Stemline Therapeutics.

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