A drug that could help prevent blood clots in certain persons is going to be reviewed on Wednesday, and even though the Food and Drug Administration is cautiously optimistic about its approval, officials still have worries.
Johnson & Johnson is the maker of the drug, which is called Xarelto. The drug is already on the market, where it’s used to treat persons who are either getting knee or hip replacement surgery or who suffer from an irregular heartbeat. Now, though, the makers of the drug want to market it as a clot prevention tool in persons who suffer from acute coronary artery disease.
The FDA has conducted its initial review through a drug reviewer, who recommends approval. This is based on the results of a 15,500 person study in which heart attack, stroke, and death risk were reportedly lowered significantly by the drug’s administration. However, there are certain risks. Those who took the drug risked suffering major internal bleeding at a rate three times greater than those who just took a placebo.
In addition, it was found that more than 1,000 people dropped out before the study’s completion. The FDA is concerned that such a significant drop-out rate and subsequent lack of data from those subjects could be skewing the results in favor of approval.
A panel will convene on Wednesday to debate approval and give their recommendation. After that, the FDA will consider final approval, which should take place on or before June 29.
The results of a new drug study have prompted the Food and Drug Administration to issue a statement regarding where they stand on the product’s risk potential.
The New England Journal of Medicine today released a report that detailed how persons who were given a five day course of the drug known as azithromycin, such as what’s contained in Zithromax, had a slightly greater risk of death from a variety of causes, including cardiovascular issues, than did persons who either didn’t receive treatments or were treated with ciprofloxacin or amoxicillin.
In responding to this study, the FDA is saying that they are reviewing the results and will release more information about their findings or any potential risks when they complete said review. In the meantime, the agency is warning consumers not to refrain from taking the drug unless they have discussed the matter with their doctors.
In March of this year, the drug label on Zmax was altered to include new information about a small heightened risk of what’s known as QT interval prolongation. This decision was made following a review by the FDA of drug labeling information on macrolides. Azithromycin is a part of this drug class.
The FDA is advising patients and doctors alike to contact them through the MedWatch program should any issues arise in conjunction with azithromycin.
In a demonstration of how crucial it is for tests to be conducted even after a drug is proven safe, the Food and Drug Administration is warning consumers about a drug that might react negatively with another substance.
The organization recently received a report about a person dying after being administered the first dose of fingolimid, a multiple sclerosis drug. After evaluating the circumstances behind that case, the FDA has now said that persons currently on certain medications that help to prevent arrhythmia or who have had a recent stroke or heart attack should probably not take fingolimid, which is used in Novartis and Gilenya.
It could not be proven that in the case studied or other post market and clinical trial data that the fingolimid contributed to any deaths looked into. However, the FDA has expressed concerns that the drug might lead to bradycardia, and recommends that, after the first dose, the person taking the drug be monitored carefully. This monitoring should be even longer, they say, in people who are more at risk of suffering bradycardia.
The FDA says that monitoring should include measurements of blood pressure and pulse rate every hour once the first dose is given. They also think that an electrocardiogram test should be administered both before and after the period of testing is over.
A seeming inability of the Food and Drug Administration to properly police pharmaceutical factories in other countries has led some lawmakers to offer up a solution.
A Pennsylvanian Congressman has put forth a bill that would provide critical funding to allow the FDA to conduct more inspections in drug factories abroad. The bill, known as H.R. 3988, would accomplish this by placing a fee on United States-based makers of generic drugs. The Congressman said that drug makers are behind him on the plan, so long as it means that inspections can be carried out and drugs can make their way onto shelves quicker.
To that end, the bill also aims to speed through the long line of generic drugs currently trying to get approved by the FDA. It does this by putting money toward the backlog. If passed, the proponent of the bill thinks that the 30 month approval process could be made more expedient.
The Congressman touting the bill referred to the recent contaminated heparin situation making headlines as the type of thing that could be prevented if the FDA were given more foreign inspection power. According to him, just shy of $300 million would go to the FDA by instituting the new fee on domestic generic drug producers.
The House Energy and Commerce Committee passed the bill last week.
The Food and Drug Administration is coming down on the makers of certain dietary supplements whose products contain an ingredient that has yet to be proven safe.
Ten different manufacturers and distributors have received a warning letter from the safety agency because their products contain what’s known as dimethylamylamine, or DMAA. Also known as geranium extract, the makers of the products many times refer to the item as a natural stimulant, but the FDA takes issue with its presence.
They say that none of the companies have proved the safety of DMAA. Because the ingredient falls under the category of New Dietary Ingredient, the companies that include it must prove through various testing that DMAA is safe before they set out to market it. Doing otherwise takes the items out of compliance with FDA regulations, forcing the agency to classify the products as adulterated.
The FDA has stated that they have not acquired evidence that proves DMAA’s safety, and in fact have anecdotal data that shows the opposite. DMAA is known to narrow blood vessels, thus increasing blood pressure. Products containing DMAA have also prompted 42 complaints to the FDA, although it should be noted the ingredient was never proven to be the cause of the reported health issues.
The companies have 15 days to respond.
Take it from a personal injury lawyer in Los Angeles like me: compliance with FDA regulations is essential to preserving safety. I hope as a Riverside personal injury lawyer that pains are taken to correct these violations, as to do otherwise could be dangerous for the citizens of this country.
A label change being issued by the Food and Drug Administration could hurt sales of a widely used Hepatitis C treatment.
The drug whose label will need to be changed is called Victrelis, which the FDA approved last May. It is produced by Merck & Company. New findings have shown that Victrelis could prevent various human immunodeficiency virus medicines from working properly if the two are taken in conjunction with each other. The new label will state this potential danger.
Hepatitis C can over time cause liver failure or some other liver disease, and Victrelis is meant to prevent that. And HIV drugs block a blood enzyme known as protease, which the HIV virus needs to replicate. But during a drug interaction study in February, researchers determined that the levels of HIV-treating drugs dropped when the user was taking Victrelis at the same time. This puts the user at risk.
Many are saying that this could hurt the sales of Victrelis. The reason is because so many people who have Hepatitis also have HIV. In fact, some estimate that sales of the drug could be reduced by as much as 25%.
I’m sorry to see these dangers as a personal injury attorney in Ventura. When a new drug hits the market that could potentially save lives, one hopes that there won’t be any complications with that drug. I’m optimistic that researchers can work it out, and as a Long Beach personal injury lawyer, I hope that persons affected with these viruses can get the treatment they need.
The potential ability of the Food and Drug Administration to track individual drug items via serial numbers might be in danger.
Over the past ten years, the FDA has struggled to put together a “track and trace” plan that would put a unique serial number on every single package of medicine that’s brought to market. However, opponents of the mandate, which range from large drug companies to smaller pharmacies, think the system is cost-prohibitive.
The problem is that the debate can’t carry on for that much longer without a significant delay in implementation. If the FDA doesn’t propose one distinct plan by this September, then they’ll have to wait another five years until they can legally bring the issue back up with Congress.
Drug manufacturers and other opponents, who say it would cost upwards of $6 billion for pharmacies to fall in line with tracking every individual medicinal package, would rather see an expanded focus on keeping tabs on every lot of a drug instead of every single package.
California was the first state scheduled to switch over to an individual drug package tracking system, but healthcare lobbyists were able to delay the measure again and again. It’s currently not scheduled to take place until 2015. Estimates hint that the national system could be ready by 2020.
This is an important issue to a personal injury lawyer in Los Angeles like me. I understand how important is is to track drugs. Such information could make issuing recalls and weeding out counterfeits easier. As a San Jose personal injury attorney, I hope that lawmakers are able to figure out how best to preserve safety.
The Food and Drug Administration is warning parents about the dangers that a certain pain reliever could pose to children should they come into contact with it.
The item is question is called the fentanyl transdermal system, more commonly known as Duragesic. This system is a patch that for three days at a time supplies the human body with a steady dosage of the pain reliever and potent opioid fentanyl. It is commonly used by persons who suffer from some kind of constant pain malady.
When children come into contact with this patch, the consequences can be injurious and even deadly. The patch is much more potent when it is swallowed, and even after three days it likely has 50% of the opioid still inside. The FDA knows of 12 children being checked into a hospital and an additional 10 deaths because of exposure to fentanyl since 1997.
To help parents combat the risks that the patch could pose to their children, the FDA advises following a few simple steps. The first is to store the patch out of reach of children. Next, they suggest placing some kind of adhesive over the patch while in use so that it doesn’t come off the user’s body. Users should check that the patch is affixed throughout the day, and when usage is complete, the item should be flushed down the toilet.
Being a personal injury attorney in Long Beach, I applaud the efforts of the FDA to raise awareness about this important topic. I hope as a San Bernardino personal injury lawyer that people across the country do what they can to mitigate the risks of fentanyl.
Communication is crucial when a patient is meeting with a healthcare professional to talk about their care plan. But what happens when this communication is compromised?
A new study suggests that the quality of translation for non-English speaking patients in American hospitals could have a direct impact on the safety of the patient. Published in the new issue of Annals of Emergency Medicine, the study involved researchers comparing the services of professional interpreters versus amateur interpreters or nonexistent interpreters. They conducted their tests by looking at 57 different Spanish speaking families at two different pediatric emergency rooms.
What they found was that 12% of translation miscues committed by professional interpreters could have resulted in an error that might have negative consequences for the child being treated. By contrast, having no interpreter or just having an amateur such as a bilingual family member relate information carried a 20 to 22% rate of consequential error.
The number of errors also tended to decrease the more experienced the translator was. Those persons with more than 100 hours of training fared best, as could be imagined. Not clear is how well such translators would fare against video and phone translation services, which are offered at some hospitals. Further studies will have to be done.
As a personal injury lawyer in Riverside, I understand how important it is for a patient and a physician to be on the same page. Miscommunication can breed errors in medical treatment, which can prevent proper healing. I hope as a San Francisco personal injury attorney that more research can be conducted in this important area so that no one is endangered by improperly administered medicine.
United States Marshals seized a number of supposed cancer curing drugs from a plant in Bogard, Missouri.
The seizure was initiated following a request by the Food and Drug Administration, who investigated the plant in January following a complaint from a consumer. The manufacturer in question, Notions-N-Things Distribution, was responsible for marketing drugs that purported to cure cancer. The FDA has said, though, that these items were not approved by the FDA and may contain ingredients that might be toxic or could pose a danger to those with allergies.
1,600 containers in total were seized by the marshals. The first item removed was chickweed healing salve, which its makers claimed could cure skin cancer, but that contains an ingredient known as comfrey which the FDA says puts the user in danger of contracting systemic toxicity. The next item, To-Mor-Gone, was seized because of the aforementioned lack of approval and because it contains bloodroot. Bloodroot is in fact a corrosive substance which, when applied to human skin, would create a scar that hides a tumor’s presence rather than outright cure it.
The third seized drug, R.E.P., supposedly fights sinus infections and headaches, but its label doesn’t list any ingredients whatsoever, thus not meeting FDA standards.
I know how important the FDA approval process is as a personal injury lawyer in Ventura. Even when companies have a consumer’s best interests at heart, it’s vital that a product is proven safe before it’s distributed to a consumer. Perhaps the makers of these items will now seek FDA approval and the items can come out with the proper labels. As a Bakersfield personal injury attorney, all I care about is that the consumer is safe.
