FDA Approves REMS Modifications for Drugs

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According to news reports, the US. Food and Drug Administration (FDA) has recently approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) to the Nplate injection and Promacta tablets, including the removal of certain elements of the REMS. The platelet-booster drugs Nplate injection and Promacta tablets are used to treat low blood platelet counts in adults with chronic immune throbocytopenea and may cause unusual bleeding. Patients and health professionals should be aware of the serious risks associated with using these drugs prior to proceeding with their use, including changes to bone marrow, increased risk for blot clots and a possible worsening of certain blood cancers.

As an Olympia personal injury attorney, I feel it is imperative to closely monitor the news from the US Food and Drug Administration in order to further provide the public with quality information that may be helpful in the prevention of avoidable injuries. If you have suffered adverse health effects through the use of a defective or harmful medical product, it may be in your best interests to consult a personal injury lawyer in your city to learn more about your legal rights as they apply to the matter.

FDA Releases Further Information on 5-ARIs

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In a press statement from the US Food and Drug Administration (FDA), the agency released information concerning 5-alpha reductase inhibitors (5-ARIs) that indicates that men taking these drugs have a higher likelihood of developing more serious forms of prostate cancer. These reductase inhibitors are a class of prescription drugs used to treat the symptoms of benign prostate hyperplasia in men. According to the FDA, men who use these drugs do so primarily in the effort of treating hyperplasia symptoms including difficulty urinating and difficulty emptying the bladder. The public can go through the FDA’s ” Warning and Precaution ” section for more information on this subject.

As an Everett personal injury attorney, I think it is extremely important to keep a close eye on the news provided by the US Food and Drug Administration to aid in spreading information that may help individuals prevent avoidable injuries. If you’ve suffered adverse health effects through the use of a defective medical product, call a personal injury lawyer experienced in these matters in your town to discuss the legal options that may be available to you.

FDA Monitors Pradaxa for Reports of Bleeding Events

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According to news sources, the US Food and Drug Administration (FDA) is in the process of evaluating post-marketing reports of serious bleeding events in patients taking the medication Pradaxia. Pradaxia is a blood thinning medication used to reduce the risk of stroke in patients with heart rhythm abnormality. However, there have been reports of serious bleeding events in patients taking Pradaxia. Now the FDA is evaluating reports of serious bleeding to weigh whether the benefits of the drug outweigh the potential harmful effects; which would necessitate either a modification of the drug’s warning label or a recall. Patients are advised not to stop taking Pradaxia without first consulting their physicians.

As a Tacoma personal injury lawyer, I feel it is essentially to closely monitor the news coming out of the US Food and Drug Administration for information that may be helpful in preventing avoidable injuries, so that I can help to make that information more widely available. If you’ve fallen ill after taking a defective prescription medication, after seeking medical attention, it may be in your interests to consult a personal injury lawyer experienced in these matters to discuss your legal rights as they pertain to the situation.

Avaira Contact Lenses Recall Due to Residue

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In a press release, CooperVision, in cooperation with and in accordance with the guidelines of the US Food and Drug Administration (FDA), announced the recall of certain lots of the company’s Avaira Sphere Soft Contact Lenses because of the potential presence of silicone oil residue on the lenses. The presence of this residue can result in blurry vision and discomfort to the eyes. This recall affects all Avaira contact lense lots that were manufactured from February 1, 2011 through August 24, 2011. Consumers are being advised to return the lenses to the place of purchase or to their eye care practitioner.

As a Bellingham personal injury lawyer, I’ve seen this kind of voluntary safety recall many times in the past and understand the devastating injuries that can result from the use of a defective product. If you have suffered an injury through the use of a defective product, it may be in your best interests to speak with an experienced personal injury lawyer in your area to learn more about your rights as a consumer and the legal avenues that may be open to you.

FDA Releases Study Results for Drospirenone

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According to news reports, the US Food and Drug Administration (FDA) announced that it released the final report of a study funded by the agency which evaluated the risk of blood clot in women using contraceptive pills containing drospirenone. The preliminary report of this study was already discussed in a previous Drug Safety Communication (DSC). The final results of the study were 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. The results stated that contraceptive pills containing drospirenone offered no further risks to patients than normal contraceptive pills. For further information, refer to the FDA’s website.

As a Seattle personal injury attorney, I feel it is imperative to pay close attention to the news coming from the US Food and Drug Administration in order to help spread helpful preventative information and, hopefully, aid in preventing avoidable injuries. If you’ve suffered adverse health effects through the use of a defective medical product, consult an experienced personal injury lawyer in your town to learn more about the legal options that may be available to you.