FDA Approves Modifications to REMS of Platelet Boosters

According to news outlets, the platelet-booster drugs Nplate injection and Promacta tablets are used to treat low blood platelet counts in adults with chronic immune [idiopathic] thrombocytopenia. The US Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) of these drugs, including the removal of certain elements of the REMS. Patients and health care professionals should be aware of the serious risks associated with these drugs, such as bone marrow changes, increased risk of blood clotting and potential worsening of symptoms associated with blood cancer.

As a Riverside personal injury attorney, I feel it is essential to keep a close watch on the news from the FDA in order to aid in making their information more available and, hopefully, help to prevent avoidable injuries. If you’ve suffered adverse health effects through the normal use of a defective drug, speak with a personal injury lawyer experienced in these matters after consulting a healthcare provider in your area.

Pediatric Medical Device Approved by FDA

According to news sources, the U.S Food and Drug Administration (FDA) today approved the EXCOR Pediatric System. This system is a mechanical pulsatile cardiac assistance device used to support the weakened heart of children with heart failure to keep them alive until a donor for a heart transplant can be found. Heart failure is much less common in children than in adults; therefore, finding a suitable donor usually takes more time. This system is designed to keep the child’s cardiac system functioning while a donor heart is being found. Stroke is a potential risk of using this system. The EXCOR Pediatric System was designated as a Humanitarian Use Device by the Office of Orphan Products Development.

As a Los Angeles personal injury lawyer, I’m glad to learn that such a device exists in order to provide children with heart failure a fighting chance. In my time as a personal injury lawyer, I’ve witnessed many advancements in medical technology; and I’m relieved to see that, though a rare occurrence, children with heart failure have benefited from such advancements.

 

FDA Requests Bleeding Reports on Pradaxa Use

In a news release, the US Food and Drug Administration (FDA) requested post-marketing reports on bleeding incidents related to the use of Pradaxa. Pradaxa is a blood-thinning drug known for reducing the risk of stroke in patients. Many drugs may have some minor side effects, but side effects like diarrhea, heartburn, indigestion, mild stomach pain and nausea may be seen when using Pradaxa. FDA has also received reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). These bleeding incidents may relate to some fatal outcomes. All of the patients currently taking Pradaxa and healthcare professionals that have prescribed it are requested to inform the FDA regarding these incidents at once.

As a Federal Way personal injury lawyer, I think it’s imperative to keep a close watch on the news coming from the FDA to aid in preventing avoidable injury. If you’ve suffered adverse health effects through the use of a defective medication, it may be in your best interests to speak with an experienced personal injury lawyer in your town.

FDA Releases Study on Blood Clots

News outlets reported that the US Food and Drug Administration (FDA) is releasing the final report of the FDA-funded study that evaluated the risk of blood clots in women using contraceptive pills containing drospirenone. The preliminary report of the study was already discussed in a previous Drug Safety Communication (DSC). The final result of the study will be discussed in a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.

As a Renton personal injury lawyer, I feel it’s essential to keep up-to-date with the news issued by the FDA in order to help spread their information and, hopefully, aid in preventing avoidable injuries. If you’ve suffered injuries or adverse health effects through the use of a defective medical device or drug, contact a personal injury lawyer experienced in these matters to learn more about your rights and the legal avenues open to you.