Sentences with phrase «of adverse reactions including»

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These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

The foods we eat are made up of various compounds including protein, fat, carbohydrates nutrients as well as natural chemicals, not to mention additives that can all single handedly cause adverse reactions.

Tens of thousands of adverse reactions to the HPV vaccine have been documented — including over 100 deaths.

It should be noted that we closely monitored our subjects for any possible adverse effects after the consumption of Golden Rice and found no evidence of any problems, including allergic reactions or gastrointestinal disturbance.

The type of proteins causing the biggest adverse reactions seem to be gliadins, which contain other proteins such as prolamins, which are in many grains in various forms, including wheat, barley, rye, corn, oats and sorghum.

These causative factors include illness, distress, hormonal imbalance, adverse reaction to certain foods and ingestion of substances those can result in some level of adverse reactions.

Some or all of these ingredients may cause adverse reactions to the wearer, including reduced respiratory function, so please exercise appropriate caution when using our product.

Seventy per cent of the websites provided information on the safe usage of prescription medications, including potential side effects or adverse reactions when combined with other drugs.

The reviewers identified several risk factors for women in the U.S. that were predictive of adverse reactions subsequent to abortion, including perceptions of stigma, a need for secrecy, low social support and personality traits such as coping style.

F. Edward Yazbak, a Massachusetts - based pediatrician, examined Jake's medical records and wrote a 51 - page report for the defense that pointed to other possible causes of baby Jake's hemorrhages, including adverse reaction to his vaccinations, a vitamin C and K deficiency, and / or a toxic level of histamine in his blood.

The British Journal of Clinical Pharmacology analysis included 49 case reports and two observational studies with 15 cases of adverse drug reactions.

On April 7 reports of adverse skin reactions and heart problems prompted the FDA to ask Pfizer to withdraw Bextra, another COX - 2 inhibitor, and to include a warning about the health risks for Celebrex.

7 men dropped out of the study due to adverse reactions, including:

The foods we eat are made up of various compounds including protein, fat, carbohydrates nutrients as well as natural chemicals, not to mention additives that can all single handedly cause adverse reactions.

If you wish to use legumes as a primary source of protein or you are vegetarian or vegan, feel free to include them once again and check for any adverse reactions.

Just like your pipes, the lymphatic system can become congested and lead to adverse health reactions including soreness of breast, fatigue, eczema and chronic skin problems, cold limbs, bloating, headaches, body rigidity, and weakened immunity (2).

Adverse Event Reactions may include any reports of serious side effects, hospitalization and deaths of individuals who have consumed a certain nutrition product.

Several studies have highlighted the adverse effects of GM crops, including reproductive problems, organ disruption, digestive problems, and allergic reactions.

Dr. Mara De Amici, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy 29th Congress of the European Academy of Allergy and Clinical Immunology, London, June 5 - 9, 2010 Abstract No. 1105 Background Specific foods and food additives can induce adverse gastrointestinal (GI) and cutaneous reactions, including food allergies that involve an abnormal immunologic reaction to food proteins or food intolerance which is not pathogenetically immune - mediated.

The price can be measured in terms of the adverse reactions from taking the drug, which may include any number of the following: diarrhea, dizziness, muscle cramps, nausea, fatigue, insomnia, vomiting, weight loss, seizures, and death.

Disorders related to protein intolerance include oral allergy syndrome, immediate gastrointestinal hypersensitivity, eosinophilic esophagitis, gastritis and gastroenteritis; enterocolitis, protein - losing enteropathy, proctocolitis, chronic constipation (as the sole symptom), atopic dermatitis, multiple food protein intolerance of infancy (to several foods, including breast milk) and celiac disease (adverse reaction to gluten).

Several of these reports document adverse effects on cows, including higher rates of mastitis, foot problems, and injection site reactions.

A study published in March 2015 in the Journal of the American College of Cardiology cites clinical data showing that even in the absence of an actual increase in blood pressure, excess sodium in the diet could harm the body, including blood vessels (for example, increased arterial stiffness), the heart (enlarged heart muscle), the kidneys (reduced renal function), and the brain (adverse sympathetic nervous system reactions).

Learn about the potential benefits of Fo - ti including contraindications, adverse reactions, toxicology, pharmacology and historical usage.

The most frequently reported adverse reactions included pruritus, vomiting, dry / flaky skin, diarrhea, lethargy, and lack of appetite.

The most frequently reported adverse reactions include vomiting, dry / flaky skin, diarrhea, lethargy, and lack of appetite.

p. 20»... the list that follows includes categories of adverse reactions that have been attributed to vaccine administration.

Adverse reactions may include erosions and ulcers of the gums, tongue, lips and face, weight loss, colic, diarrhea, or icterus.

A mutation of the gene is tied to adverse drug reactions to the heartworm medicine ivermectin, chemotherapy drugs, and other commonly used medications, including over-the-counter Imodium.

Adverse reactions observed during clinical trials include vomiting, increased liver enzymes and transient loss of hearing.

As for leptospirosis, well... other than the high number of adverse reactions (including renal failure and mast cell tumors), there are over 230 serovars of lepto, but the vaccine contains only four.

Less frequent but serious adverse reactions included two deaths following apnea and two reports of presumptive post-anesthetic cortical blindness.

When using these products, monitor your pet for any signs of an adverse reaction, including anxiousness, excessive itching or scratching, skin redness or swelling, vomiting, or any abnormal behavior.

While adverse reactions were reported for all products, applying too much product for the cat's weight, and using dog products on cats, were responsible for the majority of incidents, including deaths.

Typical signs of adverse immune reactions include fever, stiffness, sore joints and abdominal tenderness, susceptibility to infections, central and peripheral nervous system disorders or inflammation, collapse with auto - agglutinated red blood cells and jaundice, or generalized pinpoint hemorrhages or bruises.

These products can cause serious adverse health reactions in dogs and humans, and the Center for Public Integrity found over 25,000 reports of pesticide reactions have been reported to the EPA in the last 5 years (including 1600 canine deaths).

Growth hormone injections can have adverse consequences, including allergic reactions and development of diabetes mellitus, among others.

Although rashes, lethargy and loss of appetite were the most common symptoms noted by unhappy customers, a few of the reviews documented extreme adverse reactions, including seizures and neurological problems.

I was prompted to do so after receiving several reports of severe adverse reactions, including death, exhibited by cats and dogs after the administration of Convenia.

Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes.

In April 2009, the EPA issued an advisory about spot - on products after receiving over 44,000 reports of adverse reactions during 2008, including 600 deaths.

Ivermectin is the drug most commonly associated with toxicosis, although many other drugs may also cause adverse reactions (BOX 3).5 Because of the public's awareness of ivermectin - associated problems, many breeders and websites recommend avoiding all products containing this drug, including heartworm preventive agents.

Ingestion of this product by pets may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors.

They can include, for example, bacterial infections; inflammatory disease; adverse reactions to certain drugs, including some antibiotics; and a variety of growths such as polyps, tumors, cysts, and cancer.

Increased stress results in a number of adverse reactions, including immunosuppression and the creation of gastric ulcers, among other things.»

These complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels, multiple surgeries and other complications such as infection, chronic pain, and bowel and bladder problems.

Within two years of coming to market, nearly 700 serious adverse reaction were reported including several deaths.

Two months before the recall, Stryker is reported to have put out a warning to medical professionals and affected parties over concern that the rubbing together of its parts could Adverse Local Tissue Reaction, including necrosis, metallosis, osteolysis, tumor - like formations, and pain serious enough to warrant revision surgery.

Some patients have reportedly experienced various degrees of adverse reaction, including painful lumps, scarring, and permanent disability such as the inability to smile.

Project Summary: ARISg is a Drug Safety System which provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, Med Watch 3500A and many more.