Up Date Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products
September 20, 2018 The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class. Since these products have obtained their respective FDA approvals, data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures. Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations. The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products. The FDA carefully reviewed studies and other data on Bravecto, Credelio, Nexgard and Simparica prior to approval, and these products continue to be safe and effective for the majority of animals. The agency is asking the manufacturers to make the changes to the product labeling in order to provide veterinarians and pet owners with the information they need to make treatment decisions for each pet on an individual basis. Veterinarians should use their specialized training to review their patients’ medical histories and determine, in consultation with pet owners, whether a product in the isoxazoline class is appropriate for the pet. Although FDA scientists carefully evaluate an animal drug prior to approval, there is the potential for new information to emerge after marketing, when the product is used in a much larger population. In the first three years after approval, the FDA pays particularly close attention to adverse event reports, looking for any safety information that may emerge. The FDA monitors adverse drug event reports received from the public or veterinarians, other publicly available information (such a peer-reviewed scientific articles), and mandatory reports from the animal drug sponsor (the company that owns the right to market the drug). Drug sponsors must report serious, unexpected adverse events within 15 days of the event. In addition, they must submit any events that are non-serious, plus any laboratory studies, in vitro studies, and clinical trials that have not been previously submitted to the agency, on a bi-annual basis for the first two years following product approval and annually thereafter. The FDA continues to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report adverse drug events. You can do this by reporting to the drugs’ manufacturers, who are required to report this information to the FDA, or by submitting a report directly to the FDA. To report suspected adverse drug events for these products and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact the appropriate manufacturers at the following phone numbers: Merck Animal Health (Bravecto): 800-224-5318 Elanco Animal Health (Credelio): 888-545-5973 Merial (Nexgard): 888-637-4251 Zoetis (Simparica): 888-963-8471 If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems. Additional Information Fact Sheet for Pet Owners and Veterinarians about Potential Adverse Events Associated with Isoxazoline Flea and Tick Products Contact FDA 240-402-7002 240-276-9115 FAX Issued by: FDA, Center for Veterinary Medicine 7500 Standish Place, HFV-1
The dog flea (Ctenocephalides canis) is aspecies of flea(Siphonaptera) that lives primarily on the blood of dogs. The dog flea is troublesome because it can spread Dipylidium caninum. They are commonly found in Europe.
Although they feed on the blood of dogs and cats, they sometimes bite humans. They can live without food for several months, but females must have a blood meal before they can produce eggs. They can deliver about 4000 eggs on the host's fur. The eggs go through four lifecycle stages: embryo, larva, pupa, and imago (adult). This whole life cycle from egg to adult takes from two to three weeks, although this depends on the temperature. It may take longer in cool conditions.
Anatomy The dog flea's mouthparts are adapted for piercing skin and sucking blood. Dog fleas are external parasites, living by hematophagy off the blood of dogs. The dog often experiences severe itching in all areas where the fleas may reside.
Fleas do not have wings and their hard body is flattened from side-to-side and has hairs and spines, which makes it easy for them to travel through hair. They have relatively long hind legs for jumping.
Signs and symptoms Flea infestations can be not only annoying for both dogs and humans but also very dangerous. Problems caused by fleas may range from mild to severe itching and discomfort to skin problems and infections. Anemia may also result from flea bites in extreme circumstances. Furthermore, fleas can transmit tapeworms and diseases to pets.
When fleas bite humans they may develop an itching rash with small bumps that may bleed. This rash is usually located on the armpit or fold of a joint such as the elbow, knee, or ankle. When the area is pressed, it turns white.
When dogs are troubled by fleas they scratch and bite themselves, especially in areas such as the head, neck, and around the tail. Fleas normally concentrate in such areas. This incessant scratching and biting may cause the dog's skin to become red and inflamed.
Flea allergy dermatitis is developed by those dogs allergic to flea saliva. In this case, the symptoms previously mentioned are more pronounced. Because of compulsive scratching and biting, the dog may lose hair, get bald spots, exhibit hot spots due to extreme irritation, and develop infections that result in smelly skin.
Treatments Too effectively get rid of fleas and flea eggs, one should treat not only dogs but also the household and exterior regions to eliminate eggs from bedding, grass, floor, furniture and other areas.
Treatment should be given as soon as signs of fleas appear and repeated regularly. Delays in treating the infestation may lead to flea-transmitted diseases.
Once-a-month topical products are the most commonly used products to kill parasite infestations. They are normally applied on the back of the pet and their advantage is that they also provide protection from further infestations. Sprays come in the form of aerosols and pump bottles and they are meant to be applied on all parts of the pet. Dips and rinses are also available but they are not as common as the other such products because they are the most dangerous for the health of the pet.
In 2009 the US Environment Protection Agency (EPA) conducted an investigation into the reactions of many pets to topical flea products and released preliminary reports in the spring of 2010.
There are also different treatments available for dogs from natural alternatives to chemically-based products that include topical medications and oral medications. Although common remedies provide natural options with natural ingredients such as lavender, pennyroyal, neem, and sweet mace which are insect repellents care should be used since "natural" does not always mean non-toxic.
Evaluations of the toxicity of flea treatment products have been scientifically studied and are available online from the Natural Resources Defense Council and a list of less toxic and alternative treatments can be found in the reference book, Flea Control Secrets which maintains a blog specifically on flea treatment.
Control products include medicines, drops and sprays that offer different results. Some of the most common [where?]brands and their basic characteristics include:
Frontline comes in sprays, drops, general flea medication and other flea control products and it is highly effective.
Advantage is a quick-acting topical application product that stops biting fleas in three to five minutes.
K9 Advantix not only kills fleas and ticks but also offers control against mosquitoes, biting flies and lice with its waterproof formula.
Capstar is an affordable Nitenpyram pill that kills 98% of adult fleas within five hours. However, eggs and larva do not get killed so it may be necessary to combine it with another product.
Program comes in pills or liquid and it is taken monthly. It basically kills off the flea's capacity to reproduce which gradually kills off all the fleas.
Revolution is a spot application that protects dogs from heartworms, fleas and other parasites.
Biospot is an affordable option made to kill fleas, ticks, and mosquitoes. One application lasts about three months for fleas but one month for ticks and mosquitoes. It is not waterproof.
Sentinel is a monthly Lufenuron tablet that stops young fleas from molting their outer shells, and makes the females lay eggs that can't hatch.
Vectra is a once a month flea and tick treatment given to dogs. It kills all fleas and ticks that stays on the dog for a given amount of time. The formula is waterproof. The dog formula should not be used on cats as it has an ingredient that could affect the cat in negative ways.
Before choosing a treatment it is important to know the dog's weight and age. It is also important to consult a veterinarian to learn more about the products and choose the one that is best for the dog.
Alternative treatments Alternative treatments include homemade repellents. Garlic, Brewers Yeast, and apple cider vinegar are effective in repelling fleas on healthy dogs. Sick or immune deficient dogs tend to attract more fleas and may require both commercial and alternative treatment
Prevention Preventing and controlling flea infestations is a multi-step process. Prevention in the case of flea infestations can sometimes be difficult but is the most effective way to ensure the dog will not get re-infected. Controlling flea infestations implies not only that the pet has been cured and the fleas living on it are killed but also that the environment in which the pet lives is free of these parasites. And from all these, removing the fleas from the pet is maybe the easiest and simplest step given the many products especially designed to kill fleas that are available on the market.
Every female flea on the pet is likely to have laid eggs in the environment in which the pet lives. Therefore, effective prevention and control of flea infestations implies having removed the fleas from both indoor and outdoor environments, from all pets and also keeping immature forms of fleas from developing.
Removing the flea in indoor environments mainly consists of removing the fleas mechanically. This can be done by a thorough vacuuming, especially in places where fleas are more likely to be found such as below drapes, the place where the pet sleeps and under furniture edges. It is estimated that vacuuming can remove up to 50% of flea eggs. After vacuuming, one is recommended to use a specially designed product to kill the remaining fleas and to stop the development of eggs and larvae. These products are available on the market and may include carpet powders, sprays or foggers which contain adulticides and insect growth regulators.
Special attention should be paid to the dog's bedding. This should be washed every week; also the bed and surrounding areas should be treated with adulticides and insect growth regulators. Cleaning should be done at the same time in the cars, garage, pet carrier, basement or any other place where the dog is known to spend time.
Preventing flea infestations must include eliminating the parasites from the yard or kennel areas, the two places in which fleas are most likely to occur. Dog houses, patios or porches are some of the outdoor areas in which it is more likely to find fleas and those should be thoroughly cleaned. Fleas can also be carried by wild animals such as opossums, chipmunks and raccoons. One is recommended to discourage these wild animals from their property and pets by never feeding them.
Removing fleas from the pets is not a difficult task considering the advent of products that are available on the market and which are designed not only to kill fleas but also to offer protection from further infestations. The flea control products come in the shape of once-a-month topical, dog collars, sprays, dips, powders, shampoos or inject able and oral products. All these products contain an insecticide as an active ingredient which kills the fleas when coming into contact with them. Fleas absorb the insecticide which either paralyzes them or kills them.
A very important part of flea prevention is to persist with the same control measures for as long as possible. Even though the cleaning process was successful it is very likely that fleas in incipient stages still exist around the house or on the pet. The life cycle of fleas can take up to six months and that is why it is recommended to keep up with the prevention measures for as long as half a year.
Ticks are an indisputably dreaded enemy – none of us wants to find a tick on our dogs, other pets or ourselves. Besides the obvious “ick” factor, ticks are bad news because they may transmit diseases and even cause anemia or paralysis. As a dog owner, there are some basics you should know about the risks, prevention and removal of ticks. With proper knowledge, you can help protect your dog from the threat of ticks.
About Ticks Ticks are parasitic arthropods that feed on the blood of their hosts. They are attracted to warmth and motion, often seeking out mammals – including dogs. Ticks tend to hide out in tall grass or plants in wooded areas waiting for prospective hosts. Once a host is found, the tick climbs on and attaches its mouthparts into the skin, beginning the blood meal. Once locked in place, the tick will not detach until its meal is complete. It may continue to feed for several hours to days, depending on the type of tick. On dogs, ticks often attach themselves in crevices and/or areas with little to no hair – typically in and around the ears, the areas where the insides of the legs meet the body, between the toes, and within skin folds. Most species of ticks go through four life stages - eggs, larvae, nymphs, and adults. All stages beyond eggs will attach to a host for a blood meal (and must do so on order to mature). Depending on species, the life span of a tick can be several months to years, and female adults can lay hundreds to thousands of eggs at a time. The following types of ticks are among the most common seen in North America: Deer tick - Brown dog tick - Lone star tick - American dog tick - The Dangers of Ticks
Though they are known vectors of disease, not all ticks transmit disease – in fact, many ticks do not even carry diseases. However, the threat of disease is always present where ticks are concerned, and these risks should always be taken seriously. Most tick-borne diseases will take several hours to transmit to a host, so the sooner a tick is located and removed, the lower the risk of disease. The symptoms of most tick-borne diseases include fever and lethargy, though some can also cause weakness, lameness, joint swelling and/or anemia. Signs may take days, weeks or months to appear. Some ticks can cause a temporary condition called “tick paralysis,” which is manifested by a gradual onset of difficulty walking that may develop into paralysis. These signs typically begin to resolve after tick is removed. If you notice these or any other signs of illness in your dog, contact your veterinarian as soon as possible so that proper testing and necessary treatments can begin. The following are some of the most common tick-borne diseases: · Lyme disease
· Rocky Mountain spotted fever
Finding and Removing Ticks from Your Dog To search for ticks on your dog, run your hands all over the body, paying close attention to the ears neck, skin folds and other crevices. You may prefer to wear latex gloves. Closely examine any raised areas closely by parting the hair, making sure you are in a very well-lit area (you can even use a flashlight). Depending on species and life stage, a tick may be as small as a pencil point or as large as a lima bean (when engorged). If you live in an area where ticks are prevalent, or your dog spends a lot of time in high grasses or wooded areas, you should check for ticks once or twice a day. If you find an embedded tick, be sure to remove it promptly. Here’s how:
1. Wear latex gloves to protect yourself. Use a pair of tweezers or a specially-designed tick removal tool to grasp the tick at the point of attachment. This should be done as close to the skin as possible.
2. Be very careful not to squeeze the body of the tick, as this may cause bacteria and disease containing materials to be injected into the site.
3. Pull the tick straight out from the skin slowly and steadily (without twisting or turning). Some of your dog’s skin may come off with the tick, but this is normal. If bleeding occurs, apply light pressure to the area.
4. Once removed, the tick should be handled carefully. While some people prefer to flush ticks down the toilet, saving the tick for further identification is a good idea. Place the tick in a small airtight container (like a pill vial or jar). You may wish to add some rubbing alcohol to the container. Label the container with the date and store in case future illness occurs, as identification may become necessary.
5. If part of the tick’s head still appears to be embedded, use the tweezers to gently pull it out. If some of the head cannot be removed, do not become alarmed. This should fall off eventually and rarely causes complications.
6. After tick removal, clean your dog’s skin at the bite area with mild soap and water. Watch this spot for several days in case of further irritation or infection. If the area does not clear up in a few days, contact your veterinarian.
There are really no shortcuts that can make a tick release itself from its host – a tick will not voluntarily detach until its meal is complete. DO NOTapply hot matches, nail polish, petroleum jelly, alcohol or other chemicals to the site. These methods are not affective and can actually be harmful to your dog.
Tick Prevention for Dogs The best way to protect your dog from the hazards of ticks is to keep them from attaching to your dog in the first place. As stated earlier, routine checks should be done to search for ticks on your dog. Finding them before they attach is helpful, but this is not the most accurate method of prevention. To reduce the number of ticks hiding out in your yard, keep grass mowed and plants neatly trimmed. You may also choose to treat outdoor areas with pesticides, but be sure to use a substance that is safe for dogs and preferably environmentally-friendly.
One of the most effective ways to keep ticks off your dog is to directly apply a tick prevention product specifically designed for dogs. Topical products like Frontline, Revolution, Advantix, and bioSpot are designed to be applied monthly to prevent ticks. Another option is a tick collar, such as the Preventic collar. Some products are available over-the-counter while others require a prescription. Though approved for use on dogs, be aware that these products contain toxic components and should ALWAYS be used according to the directions. Do not use extra amounts of a product or apply more than one at the same time. Take note that most of these products are highly toxic to cats. Talk to your veterinarian about the best options for your dog’s lifestyle. Also be aware that not all products will work for every dog, so a bit of trial and error may be in order. With the proper knowledge, you can help defeat the dreaded tick and protect your dog, your family and yourself from the dangers of tick-borne diseases.