Sentences with phrase «reports of adverse events»

Between 2005 and 2007, the FDA received over 1,000 reports of adverse events, and the agency received another 2,874 reports between Jan. 1, 2008 and Dec. 31, 2010.

Each year FDA receives a small number of reports of adverse events associated with pet treats.

We aren't allowed to see the reports of adverse events?

The FDA is collecting reports of adverse events that have occurred in people who took products marketed as «energy drinks» or «energy shots.»

In the seven years since then, there has been a steady stream of reports of adverse events tied to Hyland's homeopathic teething products.

More details: Teva Pharmaceuticals has not received any reports of adverse events or complaints related to this recall.

Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners.

A 2015 Cochrane review of current research on cryotherapy also came to a similar conclusion: «There is insufficient evidence to determine whether whole - body cryotherapy (WBC) reduces self - reported muscle soreness or improves subjective recovery after exercise compared with passive rest or no WBC... Further high - quality, well - reported research in this area is required and must provide detailed reporting of adverse events.»

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.

In this study of both stevioside and rebaudioside A in Food and Chemical Toxicology in 2008... ``... No safety concerns were noted as determined by reporting of adverse events, laboratory assessments of safety or vital signs.»

The reports were based on voluntary self - reporting to FDA by veterinarians and owners whose dogs suffered adverse drug experiences (ADEs) to ProHeart ® 6 (which contains the drug moxidectin) as well as the mandatory reporting of adverse events by Fort Dodge Animal Health.

Between just 2005 and 2007 alone the US Food and Drug Administration said it received over 1000 report of adverse events.

• I was trained on performance of Pre-Clinical Study, Patient Registration and Inform Consent, SAE and Safety Data Reconciliation and reporting of Adverse Events in compliance with IRB stipulations.

Ensured compliance with protocol guidelines and requirements of regulatory agencies; identified problems and / or inconsistencies and monitor patients» progress to include documentation and reporting of adverse events in the areas of neurology, sleep medicine, and pulmonology.

Monitored Investigator compliance for the reporting of Adverse Events and Serious Adverse Events.

Trained on performance of Pre-Clinical Study, Patient Registration and Inform Consent, SAE and Safety Data Reconciliation and reporting of Adverse Events in compliance with IRB stipulations.

Career Summary Pharmacovigilance Director of consumer care division with an in - depth knowledge of Food and Drug Administration (FDA) regulations governing the reporting of adverse events and experienced in a GMP, compliance - driven environment.

Spontaneous reporting of adverse events will be discussed with the study clinicians and responded to according to their recommendations.

Not exact matches

The scope of the challenge can be sized up in the FDA's Adverse Events Reporting System.

More than 10,000 adverse - event reports filed with the FDA reflect the experiences of women who've taken Lupron.

Examples of these risks, uncertainties and other factors include, but are not limited to the impact of: adverse general economic and related factors, such as fluctuating or increasing levels of unemployment, underemployment and the volatility of fuel prices, declines in the securities and real estate markets, and perceptions of these conditions that decrease the level of disposable income of consumers or consumer confidence; adverse events impacting the security of travel, such as terrorist acts, armed conflict and threats thereof, acts of piracy, and other international events; the risks and increased costs associated with operating internationally; our expansion into and investments in new markets; breaches in data security or other disturbances to our information technology and other networks; the spread of epidemics and viral outbreaks; adverse incidents involving cruise ships; changes in fuel prices and / or other cruise operating costs; any impairment of our tradenames or goodwill; our hedging strategies; our inability to obtain adequate insurance coverage; our substantial indebtedness, including the ability to raise additional capital to fund our operations, and to generate the necessary amount of cash to service our existing debt; restrictions in the agreements governing our indebtedness that limit our flexibility in operating our business; the significant portion of our assets pledged as collateral under our existing debt agreements and the ability of our creditors to accelerate the repayment of our indebtedness; volatility and disruptions in the global credit and financial markets, which may adversely affect our ability to borrow and could increase our counterparty credit risks, including those under our credit facilities, derivatives, contingent obligations, insurance contracts and new ship progress payment guarantees; fluctuations in foreign currency exchange rates; overcapacity in key markets or globally; our inability to recruit or retain qualified personnel or the loss of key personnel; future changes relating to how external distribution channels sell and market our cruises; our reliance on third parties to provide hotel management services to certain ships and certain other services; delays in our shipbuilding program and ship repairs, maintenance and refurbishments; future increases in the price of, or major changes or reduction in, commercial airline services; seasonal variations in passenger fare rates and occupancy levels at different times of the year; our ability to keep pace with developments in technology; amendments to our collective bargaining agreements for crew members and other employee relation issues; the continued availability of attractive port destinations; pending or threatened litigation, investigations and enforcement actions; changes involving the tax and environmental regulatory regimes in which we operate; and other factors set forth under «Risk Factors» in our most recently filed Annual Report on Form 10 - K and subsequent filings by the Company with the Securities and Exchange Commission.

Adverse Claims Disclaimer: If someone is reporting an adverse event or a product quality complaint, please tell them to call the Johnson & Johnson (J&J) North America Consumer Care Center at 800-361-8068 during normal business hours of operation: Monday through Friday, 8 a.m. to 8 pAdverse Claims Disclaimer: If someone is reporting an adverse event or a product quality complaint, please tell them to call the Johnson & Johnson (J&J) North America Consumer Care Center at 800-361-8068 during normal business hours of operation: Monday through Friday, 8 a.m. to 8 padverse event or a product quality complaint, please tell them to call the Johnson & Johnson (J&J) North America Consumer Care Center at 800-361-8068 during normal business hours of operation: Monday through Friday, 8 a.m. to 8 p.m. ET.

There were no significant differences in adverse events between groups, which were reported by 2 % of children taking the three types of honey compared to 1 % taking placebo.

Where data were given for just one baby of the multiples, we need to know if it was decided beforehand which baby would contribute data (e.g. the first born), or if any adverse event was reported for whichever baby it happened to.

Also, there is no reporting of medical errors in the U.S., so we really don't have the data to draw conclusions, but the Institute of Medicine in 2000 reported that «at least 44,000 and perhaps as many as 98,000 Americans die in hospitals each year as a result of medical errors,» meaning that «deaths due to preventable adverse events in hospitalized patients exceed the deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516).»

Medscape: The report points out that the age of the infant is an important factor in deciding how to treat a mother, because most adverse events associated with drug exposure through breast milk occur in infants younger than 2 months.

Importantly, these benefits were achieved with just one - third the rate of serious adverse events reported in the standard chemotherapy group.

One related Grade 3 or greater adverse event of Grade 3 increased blood phosphorus was reported.

A total of 647 serious adverse events were reported, 402 (62 %) in the vaccine group and 245 (38 %) in the placebo group.

In fact, after follow - up (2.5 to 3.1 years), there were a total of 216 adverse events reported among study participants including 108 deaths, of which 27 were cardiovascular, plus 34 heart attacks, 30 strokes, 18 experienced unstable angina and hospitalized, and 79 needed revascularization procedures.

The analytic review of the FDA MAUDE database identified five adverse event reports that noted death and another 23 reports of cases necessitating urgent cardiac surgery.

Patients with multiple health issues and who are at higher risk of adverse events are less likely to receive follow - up care from a physician after visiting an emergency department for chest pain, reports a study published in CMAJ (Canadian Medical Association Journal)

Professor Marco Metra, director of the Institute of Cardiology at the University and Civil Hospital of Brescia, Italy and co-principal investigator of RELAX - AHF, said: «We have reported that all of these adverse effects of a worsening heart failure event are related to increased overall mortality and that a worsening heart failure event itself is related to a two-fold increased risk of dying in 180 days.»

In 2009, however, varenicline received a black box warning by the FDA based on their adverse event reports of neuropsychiatric symptoms like depression and thoughts of suicide.

It is left to the FDA's drug division to determine whether they are unsafe after they are on the market — a difficult task since the adverse event reports are generally considered to represent only a fraction of the actual incidents and may lack sufficient information to allow for thorough investigations.

The study team found a significantly higher risk of adverse events for broad - spectrum antibiotics compared to narrow - spectrum antibiotics (3.7 percent vs. 2.7 percent as documented by clinicians, and 35.6 percent vs. 25.1 percent, as reported by patients and families).

Over a 10 - year period, from 2006 to 2016, the FDA collected reports of «adverse events» in more than 370 children who had used Hyland's homeopathic teething tablets or gel, a similar product that is applied directly to a baby's gums.

In light of antipsychotic treatment - emergent cardiometabolic adverse events, several government reports called for efforts to improve pediatric psychotropic medication oversight in state Medicaid agencies.

Serious adverse events were reported in 9 % of patients and treatment discontinuation related to adverse events in 3.1 %.

«It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product,» the spokeswoman, Lyndsay Meyer, said in a statement.

Limitations of the study include that causality of adverse events can not be determined from the data, health outcomes are self - reported and reports from consumers vs. health care professionals can not be distinguished.

Only one woman reported an episode of drowsiness from the sham acupuncture, whereas the placebo pill recipients reported eight adverse events such as headache, fatigue, dizziness and constipation.

«There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 lots associated with Adverse Event reports compared to lots from previous seasons» the letter states.

Sixty - nine percent of patients experienced simeprevir - related adverse events while 86 percent in the telaprevir group reported telaprevir - related adverse events.

Dr. Chen went on to point out that, though 56 of the patients treated in the study experienced mild peripheral neuropathy (an adverse event characterized by tingling in the extremities, commonly reported among those treated with BV), 88 percent reported that symptoms abated over time.

There were no deaths or hospitalizations reported in any included studies of the drugs, but commonly reported adverse events included dizziness, fatigue, confusion, and visual disturbances.

Fewer patients in the combination group reported grade 3/4 adverse events than in either of the other groups, at 58 % compared with 66 % in the encorafenib group and 63 % of the vemurafenib patients.

The proportion of children reporting at least one systemic adverse event was the lowest among those aged 1 — 2 years and 5 — 6 years.

Grade 3 local adverse events consisted mainly of injection site swelling (Figure 2), which was reported in all study groups, but had a higher frequency in the 50 µg malaria vaccine group.

There is evidence that rTMS is safe and not associated with any adverse events, but given the variability in technique and outcome reporting that prevented meta - analysis, the evidence for efficacy of rTMS for seizure reduction is still lacking despite reasonable evidence that it is effective at reducing epileptiform discharges.