Sentences with phrase «reports of adverse side effects»

There are now 400 reports of adverse side effects — including 10 deaths — associated with these products, according to the FDA.

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.

Two case reports and two small case series subsequently have provided reassuring evidence regarding the limited amount of drug transferred to the infant through breast milk and the lack of adverse side effects noted in infants by nursing mothers.5 — 8

Patients in the clinical trial who got the combined therapies also had fewer serious adverse side effects than those who received only ipilimumab, the researchers report in the Journal of the American Medical Association.

«No significant safety concerns or dose - dependent adverse side effects of AVI - 7288 were reported with respect to any safety end point evaluated,» said Michael Wong, M.D., senior medical director for infectious diseases at Sarepta.

Reports show black cohosh may also cause liver damage, however millions of people use the herb with no adverse side effects.

The limited reports of complications arising from use of the modified Atkins diet (MAD) or low glycaemic index treatment suggest fewer and less serious adverse events when these more liberal modified diets are used (32, 33, 34, 35), although a prospective review of 6 MAD studies found 13 % of 92 children and adults discontinued the diet due to intolerance or side effects (36).

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

Supplementing 6 OXO appears to be clinically safe, with no adverse side effects reported; however, increased hair loss is a possible side effect of 6 - oxo

History of safe traditional use No case reports of significant adverse events with high probability of causality No significant adverse events in clinical trials No identified concerns for use during pregnancy or lactation No innately toxic constituents Toxicity associated with excessive use is not a basis for exclusion from this class Minor or self - limiting side effects are not bases for exclusion from this class»

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

There have been no reports of severe, adverse negative Acai side effects.

In 2009, the EPA noticed an increase in adverse effects from spot - on pesticides so they studied thousands of 2008 incident reports and reported the following most common side effects of common flea products:

Some pet owners choose not to use monthly medications because of adverse side effects commonly reported.

This report studies the interdependence between policy objectives via the analysis of co ‐ benefits and adverse side ‐ effects.

Shortly after its release in March of 2013, patients began reporting adverse side effects, including nausea and vomiting.

On January 31, 2014, the FDA released a statement warning of the potential complications associated with low - T treatment, and that they would be conducting an investigation into the reported adverse side effects.

Xarelto Lawsuit: Severe internal bleeding Over 2,000 cases of adverse side effects have been reported from patients who have used Xarelto.

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.

Despite the fact that these side effects have been known since at least 2010, warning labels weren't updated until 2016, following a tidal wave of adverse event reports cited by the FDA.

Side effects of meditation with possible adverse reactions are reported in the literature.