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 Food and Drug Administration is touting its ability to police drugs even after they’ve been approved.
On Saturday, the organization said that the same amount of resources are spent making sure that existing drugs are safe as are spent in the pre-approval stage of a drug’s life. The statement came following critics’ remarks that the FDA isn’t protecting consumers from drugs already on the market. The FDA has said that 385 post-market studies have been launched since 2008, and in that time, the studies have forced companies to change their product’s labels in 65 instances.
Until 2008, drug makers only had to voluntarily institute label changes if requested by the FDA. But there was a change in tide when Congress gave the FDA the ability to institute fines and order label changes on drugs that had already been brought to market. These new powers came two years after the Institute of Medicine released a report suggesting that the FDA could do more to promote product safety post-approval.
2008 was also the year that the FDA launched a program called Sentinel. This program uses computers to track side effects through a number of databases, discovering problems without having to rely on a patient or a company making a report.
As a personal injury attorney in Riverside, I’m glad to see more efforts being made to keep consumers safe from already existing products. It’s always possible that time can prove an item to be unhealthy. New drugs can certainly be hazardous, but as a Ventura personal injury lawyer, I know that existing products can also pose a threat in certain circumstances.
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.
According to news sources, the drug Isentress (raitegravir) has been given expanded approval by The Food and Drug Administration to begin being used by those between 2-18 years of age.
The drug was first approved for adult usage back in October 2007 under the agency’s accelerated approval program, which aims to make the introduction of new drugs aimed at treating serious diseases to the market faster.
The drug was expanded for use by children and adolescents after a clinical trial including 96 children found that after 24 weeks of Isentress treatment, about 53 percent of patients showed no detectable amount of the virus in their blood.
The drug does not cure the HIV infection and should reportedly be used with other antiretroviral drugs to control illnesses associated with HIV.
As a Los Angeles product liability lawyer, I appreciate all efforts being made to ensure increased drug safety standards for everyone . I hope this information can help raise awareness about this product and keep consumers safe. If you or a loved one has been injured through the use or consumption of a defective product, speak with a personal injury lawyer Los Angeles to learn about the legal options available to you.
According to news sources, the Food and Drug Administration has recently approved a medical device to help children suffering from heart failure that will reportedly to stay alive while a heart transplant donor can be found.
The device us called EXCOR Pediatric System and was developed by Berlin Heart for the purpose of fitting the different sizes of children, from newborns to teenagers.
The average waiting time for a donor heart in the U.S is about 119 days due to the limited amount of pediatric sized donor hearts available usually available. The percentage of children with heart diseases who lose their lives while waiting for a heart transplant is reportedly about 23 percent.
The EXCOR device is intended to relieve some of the symptoms associated with heart disease until a heart transplant can be found, thereby increasing the chances of survival. It reportedly functions by pumping blood through multiple tubes to the heart chambers.
As a personal injury lawyer Los Angeles, I am glad to see advances being made in the medical field that will help those suffering from debilitating injuries and illnesses. The conclusions of this innovative endeavor seem to suggest benefits to patients who suffer from heart disease. As a Los Angeles personal injury attorney, I hope that readers will find this information useful.
According to news sources, the Food and Drug Administration has just given approval to InfraScan Inc. of Philadelphia to begin marketing the first non invasive hand-held device to be utilized in detecting bleeding skulls.
The device, named the Infrascanner Model 1000, uses near-infrared spectroscopy to help identify bleeding in the skull. Health care providers will be able to utilize the device to extract crucial information about the patient. In conjunction with other clinical information, the healthcare provider can then determine the need for further diagnostics, by using for example a CT scan.
The device utilizes a certain wavelength of light that is capable of penetrating both bone and tissue and transmit the crucial information to a handheld computer.
An FDA review found that the device was able to detect up to 75 percent of hematomas cases that CT scans detected.
As a personal injury lawyer Los Angeles, I appreciate all efforts made to ensure higher safety standards to protect those injured in collisions and accidents on the roadway. The conclusions of this innovative endeavor seem to suggest that the detection time of bleeding skulls will be shortened in some cases by utilizing this device. As a Los Angeles personal injury attorney, I hope that supplying this information will help people stay safe.
According to news sources, The Food and Drug Administration has recently approved the first drug aimed at treating a rare kind of bone marrow disorder that causes a build up of red blood cells in the bone marrow.
The drug comes in the form of a pill and is taken twice daily to treat myelofibrosis. Approved as part of the FDA’s new priority review program, which attempts to expedite the review duration of newer drugs, the drug was cleared Wednesday to enter the market.
Drug makers Incyte Corp., introduced the new pill called Jakafi, after two studies involving 528 people with the disease found that those who took the new drug experienced a significant reduction in the symptoms associated with the disorder.
The company reportedly estimates that there are anywhere between 16,000 to 18,500 people in the U.S thought to have the rare disorder.
The disorder is currently being treated with either chemotherapy or a bone marrow transplant.
As a personal injury lawyer Los Angeles, I’m glad to see that research is continually being conducted to provide safer and more advanced drugs for those with rare diseases. I hope patients will find the conclusions of this study useful. If you or someone you care about has been injured or suffered from the use of an unsafe product, I recommend you contact a product liability lawyer Los Angeles as soon as possible.
According to news sources, U.S Marshals received calls from The Food and Drug Administration to seize Syntec Inc. dietary supplement products due to false claims by the manufacturer in regards to the effectiveness of the drug to treat and cure certain diseases.
The FDA announced the measure after the manufacturer reportedly introduced new products to the market without FDA review. The marketing claims of the new drugs state that it could be used to prevent, treat or cure diseases such as cardiovascular disease and asthma, among others. The dietary supplements have brand names BoneCare, CardioCare, DigestiveCare, JointCare, SynBio, SynBio-X, SynCell, SynGevity, SynOmega, SynOPC, SynOPC-X, SynPhyto-K, SynVita, and VisionCar, the FDA said.
The agency has said that the claims of the company are not approved by the FDA.
As a product liability attorney Los Angeles, I’ve seen dangerous products of this kind in the past and know the severity of the hazards they entail. I hope this information can help raise awareness about this product. If you or a loved one has been injured through the use of a defective product, speak with a Los Angeles personal injury lawyer to learn about the legal options available to you. Please, continue to visit our blog for regular updates about unsafe and dangerous consumer products.
