Category Archives: Drug Side Effects

By Alex Johnston Epoch Times Staff Created: March 9, 2013 Last Updated: March 9, 2013 Merck drug side effects: A study found that a cholesterol drug from Merck had serious side effects. The pharmaceutical giant said it would take it off the market in other countries and would not seek U.S. approval. A study of Merck & Co.s Tredaptive, which is used to raise good HDL cholesterol, showed serious and unexpected side effects, it was reported Saturday. Tredaptive was pulled from the market earlier this year because it had serious side effects like bleeding and infections, reported Bloomberg News, citing results of a clinical trial. It also did not help patients. The drug is intended to lower the risk of heart attack, stroke, death, and reduce the need for surgery. However, after a study of 25,673 patients, the drug failed to produce positive results, the news agency said. Reuters reported that the Tredaptive is primarily used by people taking drugs to lower bad LDL cholesterol. Tredaptive is comprised of niacin with laropiprant, an experimental drug that is used to prevent facial flushing that occurs when a person takes niacin. Niacin has been used for many years in the belief that … Continue reading →

Editor's Choice Main Category: Cardiovascular / Cardiology Also Included In: Cholesterol;Vascular Article Date: 11 Mar 2013 - 0:00 PDT Current ratings for: Merck's Long-Acting Niacin Drug Has Serious Side Effects A major study (HPS2-THRIVE) found that Tredaptive, which consist of the vitamin niacin combined with anti-flushing agent laropiprant, provides no benefit and may even be hazardous for patients with vascular disease. The HPS2-THRIVE study involving 25,673 patients, which lasted four years, tested a combination of ER (extended-release) niacin with laropiprant on patients with heart disease, stroke and other cardiovascular problems - 14,741 patients were from Europe (United Kingdom and Scandinavia) and 10,932 were from China. They were randomly selected to receive either ER niacin/laropiprant 2g/40mg or a placebo. They were all on simvastatin (with or without ezetimibe) - simvastatin is a widely prescribed cholesterol-lowering drug. HPS2-THRIVE did not meet the primary endpoint of reducing the risk of a major vascular event, defined as the composite of nonfatal heart attack or heart-related death, a need for angioplasty or bypass surgery, or stroke. Those in the ER niacin/laropiprant group had approximately the same rates of major vascular events as participants in the placebo group (13.2% vs. 13.7%). Tredaptive combines extended-release niacin with … Continue reading →

Attorney (866) 735-1102 Ext 530 Scientists from Microsoft, Stanford and Columbia Universities have discovered information on unreported side effects due to prescription drug interactions. Even the U.S. Food and Drug Administrations (FDAs) Adverse Event Reporting System did not indicate drug interactions between an antidepressant, paroxetine and a cholesterol-reducing drug, pravastatin. The data indicated a combination of the two drugs, according to a recent New York Times article, causes an increase in blood sugar, hyperglycemia, in some patients. The FDA requests physicians report adverse drug reactions they are aware their patients have experienced using the Adverse Event Reporting System. Because the data compiled are reported by physiciansand more often the adverse reactions are noted by patients who dont always inform their physiciansthe Adverse Event Reporting System is not completely comprehensive. Instead, scientists used a data-mining technique to review FDA reports on drug-drug interactions which contained anonymized data gleaned from a software toolbar used by people who allowed their search histories to be collected. The data consisted of 82 million individual searches for drug, symptom and condition information, according to Markoff. (NYTimes, 3/7/13) The scientists determined that people who had searched on side-effects from both drugs were more likely to have included … Continue reading →

New Infographic released by dOliveira & Associates details potential Side Effects, Company Reports, and Independent Medical Studies that surround the drug meant to prevent blood clots in patients. (PRWEB) March 11, 2013 Sources: *http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf **us.boehringer-ingelheim.com/content/dam/internet/opu/us_EN/documents/Media_Press_Releases/2010/Pradaxa%20fact%20sheet%20101910.pdf ***http://www.adverseevents.com/monitor/2012/12/20/fda-states-pradaxa-contraindicated-in-patients-with-mechanical-heart-valves/ The FDA approved Pradaxa for sale on the market in October 2010 and in its first two years on the market, Pradaxa accounted for more than $1 billion in sales for the drug maker Boehrigner Ingelheim*. The drug was marketed as a better option than the traditional drug, Warfarin. However, medical studies have discovered that Pradaxa is actually more dangerous than Warfarin, for example, a study conducted by the Cleveland Clinic found that the drug increased a patients risk of heart attacks by 33 percent compared to other similar drugs as reported by CBS News article Study: Higher heart attack risk from pradaxa**. Additionally, excessive bleeding from Warfarin has an antidote, Vitamin K, but no such antidote exists for Pradaxa*. The number of side effects combined with the absence of an antidote has caused patients to file nearly 18,000 adverse event reports with the FDA*. According to Adverse Events, an organization that standardizes, the most common side effects were gastrointestingal bleeding (1668 reports), indigestion … Continue reading →

Merck & Co. (MRK)s cholesterol drug Tredaptive, pulled from the market earlier this year, increased side effects like bleeding and infections and didnt help patients, according to results of a clinical trial. The study of 25,673 patients found Tredaptive failed to reduce the risk of stroke, death, heart attack or the need for surgery in people with vascular diseases. The drug combines the vitamin niacin, which studies suggest can help raise levels of good cholesterol, with the experimental medicine laropiprant, added to reduce a face-flushing effect of the vitamin. The results of the study, called HPS2-THRIVE, could change the use of niacin, which is often used to supplement cholesterol-lowering drugs, said the studys lead investigator. Niacin has been used for many years in the belief that it would help patients and prevent heart attack and stroke, but we know now that its adverse side effects outweigh the benefits when used with current treatments, Jane Armitage, the studys lead investigator and a professor of clinical trials and epidemiology at the University of Oxford, said in a statement announcing the results. The data were presented today at the American College of Cardiology meeting in San Francisco. Patients in the trial were also … Continue reading →

By Bill Berkrot March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding a final nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to show benefit in preventing heart attacks, strokes, death and other complications in heart patients also taking statins to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the final results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent … Continue reading →

Scientists acknowledge that an individual's search data doesn't always reflect an accurate picture. STORY HIGHLIGHTS (TIME.com) -- Researchers looking for previously undiscovered drug side effects are turning to web searches for answers. When drugs are approved by the Food and Drug Administration, they are vetted for potential side effects, and drug makers are required to divulge these on their products' labels. But not all side effects emerge in the short term studies that manufacturers conduct, so many only come to light when hundreds of thousands, and even millions of people start using a medication. And what better way, a group of researchers from the Stanford University School of Medicine and Microsoft Research decided, to suss out some of these unexpected side effects than to turn to where people are most likely to report, share and ask about them -- the internet. The researchers combed through a year of web search history from 6 million Internet user volunteers. Using automated tools, the scientists were able to to mine anonymous data from 82 million drug-symptom and condition searches made by the participants who agreed to let the users install a Microsoft plug-in to monitor their history. The team was rewarded with a … Continue reading →

By Bill Berkrot SAN FRANCISCO, March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs 1.9 … Continue reading →

SAN FRANCISCO (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs. 1.9 percent - and infections - 8.0 percent vs. 6.6 percent … Continue reading →

Mar. 6, 2013 Internet searches on health symptoms can be used to identify drug side effects and could be used to develop a new kind of early warning system to boost drug safety, indicates a study published online in the Journal of the American Medical Informatics Association. The authors base their findings on an analysis of the anonymised search logs of millions of US web users, who agreed to install a browser add-on and share their online searches with Microsoft throughout 2010. The researchers developed automated tools to analyse the queries of people who searched for information on the antidepressant (paroxetine) and a cholesterol lowering drug (pravastatin), using the search engines Google, Bing and Yahoo. In 2010, it was not yet public knowledge that taking both these two drugs caused high blood sugar (hyperglycaemia), but the authors later extracted this information by mining the US drugs regulator's medicines side effect reporting system (AERS) and confirming the finding in a separate laboratory study. In the web log study, the authors looked at whether people who had searched online for either one of the drugs separately, or for both of them, would also search with queries containing terms associated with the symptoms … Continue reading →