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.
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.
According to news sources, a recall has been issued for several topical Perfect Image Solutions products after they were deemed as “unapproved new drugs” by the Food and Drug Administration due to the potential health hazards they pose to consumers.
Some of the recalled products include 10-15 percent Minoxidil, which can be reportedly unsafe due to the potential of systemic absorption, increasing the risk of heart palpitations and low blood pressure. The recalled products come in either glass dropper or plastic shampoo bottles and have UPC codes 736211276018, 736211275813, 736211276117, 736211274519, and 736211276414.
There have been no illnesses reported to date.
Those with the recalled products should stop using them immediately and discard them. Consumers can also contact the company directly at 916-791-3230 for additional information regarding the recalled product.
As a Riverside personal injury 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 attorney Riverside to learn about the legal options available to you.
According to news sources, a patients hope to find a cure that may not yet exist could potentially entice them to believe untrue stem cell claims made by unscrupulous providers, the Food and Drug Administration warns.
Stem cells behave like the body’s “master cells”, with enormous potential in treating medical conditions with no existing treatments available today. However, therapies utilizing stem cells can potentially cause harm to patients if they have not been approved or are being considered under a clinical investigation conducted by the FDA.
The FDA already regulates approved cord blood procedures, with all cord blood banks having to follow the requirements set forth by the FDA. Therefore, patients interested in stem cell treatments in the U.S. are urged to check for the necessary FDA approval or clinical study backing before considering treatment.
No other stem cell product, other than certain blood cord procedures, have been approved by the FDA to date.
As a Los Angeles product liability lawyer, I appreciate all efforts being made to ensure increased healthcare safety standards for those interested in new and effective treatments. I hope this information can help raise awareness about this medical practice 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 ruled that the popular drug Avastin should not be used to treat advanced breast cancer as the danger of potential side effects outweigh the benefits the drug offers.
The drug will remain in the market nonetheless, as it is used to treat colon cancer as well as other malignancies. Aside from remaining in Medicare coverage policies, doctors will reportedly also still be able to prescribe the drug to their patients. Studies have found that the drug does not help patients live longer and that the side effects of the drug outweigh its benefits.
There have been a some insurers that have already reportedly quit the drug, anticipating the FDA ruling for some time.
The drug was approved by the FDA back in 2008 as it offered hope that it could delay the spread of breast cancer for a few months.
As a Los Angeles personal injury attorney, I appreciate all efforts being made to ensure increased healthcare safety standards for patients. I hope this information can help raise awareness about this practice 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 product liability lawyer Los Angeles to learn about the legal options available to you.
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 announced that a Chicago based ready-to-eat sandwich maker has shut down manufacturing after a repeated history of violations and a reported Listeria outbreak.
The company, Triple A Services Inc., has announced the closure of of the manufacturing facility after agreeing to stop producing and distributing its ready-to-eat sandwiches. The agreement also stipulates that the company hire a sanitation expert to oversee the company’s sanitation program and ensure its compliance with existing FDA safety regulations.
There have been no illnesses to date relating to the consumption of the company’s sandwich products.
The company’s manufacturing facility reportedly experienced a Listeria monocytogenes outbreak recently, helping prompt the decision to close the facility. Listeria can cause severe or even fatal infections to those with weak immune systems, the elderly and children.
As a Los Angeles personal injury lawyer, I urge you to be mindful of threats from food-borne bacteria. Consumers that have purchased a known defective product should stop using it immediately. If you or a loved one have been injured by a defective product, I urge you to contact a product liability lawyer Los Angeles to learn about your legal options.
According to news sources, the drug Multaq is getting a new safety warning after a study found increased risks of heart attack, stroke and death associated with the drug with a subset of patients that took part in the study.
The heart rhythm drug controls the heart’s chambers by allowing them to pump in sync for patients with atrial fibrillation. The new warning would allow the drug to remain on the market but would stress to doctors and patients that it be used only for treatment of the short-term variant of the condition. People with permanent atrial fibrillation were shown to double their risks of heart-related complications by using the drug.
The Food and Drug Administration has written the warning label with the drug-maker, Sanofli, urging doctors to check their patients heart rhythms once every three months to ensure that no adverse effects are taking place. As for patients who have the long term variant of the condition, the FDA is recommending that they discontinue the drugs use.
The FDA also said that the drug continues to be beneficial to patients.
As a personal injury lawyer Los Angeles, 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 Los Angeles product liability lawyer to learn about the legal options available to you.
According to news sources, raw materials for dietary supplements containing ephedrine alkaloids have been seized by U.S Marshals directed by the Food and Drug Administration in an attempt to reign in on the banned material.
The seizure of the raw materials imported by Infinity Marketing Group, Inc. totals a value of about $70,000.
The FDA has been heavily involved in attempting to reign in the material found in certain dietary supplements after a 2004 ban was issued due to the potential risks associated with the material, which include heart attack, stroke and death.
The FDA confirmed in a chemical analysis of shipping drums that the banned materials were reportedly present without being identified through the drum labels.
The seizure took place in Rancho Dominguez in California as part of a continues effort to remove the dietary supplements containing ephedrine alkaloids from the market.
As a personal injury lawyer Los Angeles, I understand the inherent dangers of defective products and the risks they entail. I hope this information can help raise awareness about this recalled 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 product liability 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.
