Tag: FDA

FDA Public Health Alert: Avoid using King Bio drugs and homeopathic products

Drugs and homeopathic products manufactured by King Bio Inc. (Asheville, NC) may contain high levels of microbial contamination and pose a risk to humans and pets.

In an alert posted today, FDA recommended that consumers stop using these products, and dispose of them immediately.

The FDA announcement coincided with a voluntary nationwide recall initiated by the manufacturer of all aqueous-based products for human and animal use. A complete list of recalled products has been posted on the company’s website.

This is the third product recall announced by King Bio since July 20, 2018.

Among the products included in the most recent recall are: Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief.

The recall announcement and the associated consumer alert follow an inspection of the company’s manufacturing facility by FDA – an inspection that uncovered substandard conditions, including recurring microbial contamination associated with the water system used to manufacture the drug products.

FDA found several microbial contaminants during the course of its investigation, including Burkholderia Multivorans, a strain of bacteria that can cause illness in people with compromised immune systems.

What should consumers do?
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program:

For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.

FDA continues to review possible link between pet diets and canine heart disease

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

A diet rich in legumes or potatoes might be linked to an increased risk of canine dilated cardiomyopathy (DCM), according to the Food and Drug Administration.

Prior to issuing a public notice on July 12, the FDA had received sporadic reports involving 30 dogs and 7 cats over a three-year period. During that same period, the veterinary cardiology community received about 150 similar reports. In dogs, the disease results in an enlarged heart.

Some of the dogs exhibited signs of heart disease, including decreased energy, cough, difficulty breathing, and episodes of collapse. Reports received by FDA identified a range of brands and formulas. 

The common element in these foods appears to be the presence of legumes (including peas, beans, lentils, chickpeas, soybeans, peanuts), pulses (seeds of legumes), and/or potatoes as main ingredients in the pet foods. The list also encompasses protein, starch or fiber derived from legumes.

Since the July 12 notification, FDA has received additional reports, which it is in the process of evaluating. None of these reports involve cats. According to a spokesperson from FDA, the agency is not able to provide an accurate accounting at this time, as the number of reports is continuing to rise and the information is being analyzed as it is received.

Some dog breeds are genetically susceptible to developing DCM. However, at least some of the initial reports to FDA involved other breeds of dog not typically prone to this disease. FDA is evaluating various possible dietary causes of DCM in dogs, including, nutritional makeup of the main ingredients or how dogs process them, main ingredient sourcing, processing, and amount used.

At this point in its investigation, FDA is not advising dog owners to make any dietary changes. Pet owners whose dogs are showing any symptoms of DCM or other heart conditions should contact their veterinarian.

FDA is encouraging pet owners and veterinary professionals to report cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators.

FDA warns of possible link between food, canine heart disease

This article by Phyllis Entis first appeared in Food Safety News and is reposted here with permission. 

Pet foods containing peas, lentils, other legume seeds or potatoes as main ingredients may be linked to cases of canine dilated cardiomyopathy (DCM) in dogs, according to an alert to pet owners this week from the Food and Drug Administration.

Certain large and giant breed dogs, including great danes, boxers, Newfoundlands, Irish wolfhounds, saint bernards and doberman pinschers, are thought to have a genetic predisposition to DCM. Atypically, cases of DCM reported to FDA have been of mixed breeds and of smaller breeds that were not thought to be predisposed to this condition, including: golden and Labrador retrievers, whippets, a Shih Tzu, a bulldog and miniature schnauzers.

Canine DCM is a disease of the heart muscle, resulting in an enlarged heart, which can lead to congestive heart failure if not treated successfully. Dogs suffering from DCM may show symptoms of heart disease, such as decreased energy, cough, difficulty breathing and episodes of collapse.

In June 2017, Dr. Joshua Stern,  associate professor of cardiology in the School of Veterinary Medicine at the University of California-Davis, alerted the veterinary community to reports of  DCM in golden retrievers that were taurine-deficient.

Taurine is an amino acid, which is a building block of protein, necessary for heart health. It is normally found in animal tissue, including red meats, poultry and seafood. Taurine is not present in plant tissue. Although it is not considered to be an “essential” amino acid in the canine diet, some dry dog foods are supplemented with taurine.

Dogs that receive an adequate amount of the amino acids cysteine and methionine are able to produce taurine for themselves. Both cysteine and methionine are found in significant concentrations in meats, poultry, seafood and dairy products. These essential amino acids tend to be found at relatively lower concentrations in most edible plants, including peas, potatoes and lentils.

In four atypical cases of DCM reported to FDA, three golden retrievers and one Labrador retriever, blood tests revealed low whole blood levels of taurine. The Labrador retriever is recovering under veterinary treatment, including taurine supplementation and a change in diet.

Four other atypical DCM cases in a miniature schnauzer, a Shiuh Tzu and two Labrador retrievers, had normal blood taurine levels.

FDA has contacted pet food manufacturers to discuss the reports and to help further the investigation.

The FDA encourages pet owners and veterinary professionals to report cases of DCM in dogs suspected of having a link to diet by using the electronic Safety Reporting Portal or calling their state’s FDA Consumer Complaint Coordinators. See “How to Report a Pet Food Complaint” for additional instructions.