Sentences with phrase «report of adverse reactions»

By law, the manufacturer is required to send a monthly report of adverse reactions to the appropriate federal regulating authority.

We have already discussed reports of adverse reactions with the Department of Health and can pass on reports from concerned parents to the appropriate experts.»

The Department of Health said at that time it would log reports of adverse reactions in the UK.

There have been anecdotal reports of adverse reactions of babies fed on the newly formulated SMA PRO.

Reports of adverse reactions to the U.S. Food and Drug Administration (FDA) also support this, as aspartame accounts for over 75 percent of the adverse reactions to food additives reported to the FDA.

There are few cases reported of adverse reaction of neem capsules.

The trend toward USA - made and - sourced treat products has been catapulted to the forefront in recent months, as reports of adverse reactions among dogs to China - sourced chicken jerky products have been blared across the media.

Over the past 20 years, the Senior Dogs Project has received or been made aware of reports of adverse reactions to almost every veterinary drug on the market.

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.

The FDA has received reports of adverse reactions in dogs receiving the drug Comfortis (spinosad) concurrently with high, extra-label doses of ivermectin.

Since the product was approved in June 2001, the FDA Center for Veterinary Medicine (CVM) has received over 5,000 reports of adverse reactions suspected of being associated with ProHeart ® 6.

It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public «Do Not Compound» list.

Not exact matches

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.

Some sources claim 4.5 % of people who eat Quorn get sick, while other sources say just 1/140, 000 report adverse reactions.

«We found that Asian and black patients have a substantially higher risk of severe cutaneous adverse reactions to urate - lowering drugs than do white or Hispanic patients, which correlates with the frequency of the HLA - B * 5801 gene in their U.S. populations,» says Hyon K. Choi, MD, DrPH, of the MGH Division of Rheumatology, Allergy and Immunology, senior author of the report that has been published online in Seminars in Arthritis and Rheumatism.

Will reporting of adverse drug reactions (ADRs) by patients refine our medicines (18 June, p 32)?

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.

There were no reports of any serious adverse reactions to GES, after scrutiny by independent clinicians.

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.

For example, drugs as well - known as aspirin have different effects in men and women, and women report a higher rate of adverse reactions to drugs than do men.

It produced no adverse reaction when injected into cat - allergic mice and protected them from an injected dose of pure cat protein, report the researchers online 27 March in Nature.

No serious adverse reactions to PRX002 were observed in trial participants: some people reported skin reactions such as rash at the infusion site, and there were a few reports of constipation, headaches, or peripheral edema.

Serious adverse reactions were reported in approximately half of the study participants.

While prostate changes can occur with testosterone replacement, a study published in The Journal of Clinical Endocrinology & Metabolism in June of 2010, which looked closely at the adverse reactions reported in 51 other studies, found there to be no increased risk of the development of prostate cancer, prostate related urinary symptoms, or elevated PSA (prostate specific antigen).

These adverse reactions to the ingredients have been reported to the manufacturers and distributors of dietary supplements, which are then reported to the FDA.

However, manufacturers and distributors are now required to send reports of Adverse Event Reactions to the FDA, thanks to the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed in the late 2016.

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

However the number of case reports detailing adverse reactions and mild - serious side effects is concerning.

As a result, few people have heard of the deadly soy / peanut connection, and numerous adverse reactions have been reported.

While no adverse reactions have been reported, because of the lack of information on achiote during pregnancy and breastfeeding, it is advised to limit the consumption of the herb in women going through these stages.

So, many incidents of adverse reactions to these dangerous drugs are not reported, making the actual... Read More»

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

Some studies suggest that poinsettia sap can be irritating to the skin, and, of course, any adverse reactions to plant ingestion should be reported to poison control centers.

Keep in mind that adverse events are generally underreported (vets don't have time, pet owners don't bother or don't realize that they can report the reaction themselves) and it's estimated as many as 99 percent of reactions aren't reported.

The Canine Health Foundation issued a report pointing to a higher incidence of adverse reactions to vaccines in sterilized dogs.

It is clear that veterinarians are not adequately trained to recognise vaccine reactions, and that although the cause and effect is fairly clear if one understands the potential adverse effects of vaccines, the adverse event reporting schemes don't pick up most of these cases.

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

In 2009, the U.S. Environmental Protection Agency (EPA) reported adverse reactions from flea & tick control products had doubled since 2005 — mainly due to misapplication.1 After an extensive evaluation of all flea & tick products, the EPA found most adverse drug events were minor, but there were major incidents, too.

(15) Finally, the AKC - CHF report demonstrated a higher incidence of adverse reactions to vaccines in neutered dogs as compared to intact.

As you can see from the above chart, Hartz topical treatments for cats and dogs accounted for a total of 2,513, or 5 %, of the over 52,000 adverse reactions reported.

Companies can display the NASC seal of approval if they adhere to a strict code - of - conduct contract that requires on site audits, compliance with label claims, adverse reaction reporting, quality control, and random product testing.

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

Other adverse reactions reported in decreasing order of frequency are: depression / lethargy, decreased appetite, incoordination, diarrhea, itching, trembling, excessive salivation and seizures.

Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, one of the components of Trifexis.

Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad, one of the components of Trifexis.

Report ANY adverse reaction to pet food to your State's Dept of Agriculture!

Both have also told me, and the AAHA report warns as well, about the dangers of adverse reactions for multiple vaccines given at once, especially for smaller and medium - sized breeds.

If you or your veterinarian suspects that an adverse reaction is related to the use of an arthritis medicine or any drug, it should be reported to the pharmaceutical company.

The best case of this is looking at some of the adverse reactions reported with placebo studies.