Sentences with phrase «report side effect risks»

Redberg says observational data — which follow real - world patients on statin therapy — report side effect risks much higher than those in the CTT analyses.

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.

The FDA noted in its public advisory that it is «aware of reports of serious side effects» in children between two and 11 years old, but is still reviewing information about risks in that age group.

The 8 % of Americans who report never using over-the-counter medications for cold or flu symptoms and the 20 % of Americans who have used alternative medicine instead of conventional treatment are more concerned about the risk of side effects from the MMR vaccine.

This increases cost, may lessen effectiveness and increase risk of side effects, OSU researchers said in their report.

In a 2014 study published in Clinical Therapeutics, the team from PPMD and Johns Hopkins reported that most respondents said they would accept some risk of serious side effects in exchange for delaying muscle deterioration in the boys they care for.

As with every other substance, taking large doses might cause some side - effects, although no serious cases have been reported so far, so the risk remains low.

Other rare side effects that have been reported with ketogenic therapy are increased infection risk, bruising, raised uric acid in the blood, bone fractures, pancreatitis, lipid - aspiration pneumonia, and cardiac abnormalities (1, 6, 27, 28, 29).

The delicate balance between the human microbiome and the development of psychopathologies is particularly interesting given the ease with which the microbiome can be altered by external factors, such as diet, 23 exposure to antimicrobials24, 25 or disrupted sleep patterns.26 For example, a link between antibiotic exposure and altered brain function is well evidenced by the psychiatric side - effects of antibiotics, which range from anxiety and panic to major depression, psychosis and delirium.1 A recent large population study reported that treatment with a single antibiotic course was associated with an increased risk for depression and anxiety, rising with multiple exposures.27 Bercik et al. 28 showed that oral administration of non-absorbable antimicrobials transiently altered the composition of the gut microbiota in adult mice and increased exploratory behaviour and hippocampal expression of brain - derived neurotrophic factor (BDNF), while intraperitoneal administration had no effect on behaviour.

A risk of diabetes has been reported following long - term selenium supplementation, but few data are available on the side effects associated with such supplementation and further studies are required.

According to an article from Agence France Presse (AFP) who have seen a leaked draft of that report, the panel gives the «thumbs down» and «pours scorn» on a clutch of wacky plans to intentionally re-engineer large scale ecosystems, referred to collectively as geo - engineering: «Geo - engineering options... remain largely speculative and with the risk of unknown side - effects» claims the IPCC draft according to AFP (1).

Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event Reportingreporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event ReportingReporting Program.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse - control risk that we identified.