FDA ANNOUNCES NEW SYSTEM FOR ASSESSING DRUG RISKS. CALIFORNIA DRUG SIDE EFFECT LAWYERS HERE TO HELP.
The U.S. Food & Drug Administration (FDA) has finally decided to go ahead with a new way of assessing drug risks, after years of experts and consumers requesting that the organization do something to combat the thousands of injuries and deaths reported each year from previously approved medicines. The new system, which is far from ideal, will use information gathered from Medicare claims to review the potential risks of drugs that are available on the market. Drugs including Avandia, Zyprexa, Trasylol, Heparin, Fentanyl, and Gadolinium have been shown to cause serious side effects and death after FDA release and approval. As a result these drugs and others have since been recalled or re-marketed with severe warnings. Lawsuits against drug makers and the FDA are ongoing. If you or a loved one has experienced adverse effects or death due to a medication in California, please contact a personal injury lawyer immediately for help. Call 1-800-ALAWPRO now to get your free consultation.
The FDA’s new plan, called the Sentinel Initiative, would use Medicare records to evaluate risk. The evaluation would be confidential and not include personal patient information. Experts hail the plan as much need if not flawed. The Initiative would have the capacity to examine how drugs affect health almost immediately from their release on the market. Under previous guidelines and methods, it has taken months or years to assess the “unexpected” side effects of medications. This time lag has sadly resulted in thousands of injuries and deaths before anything happened to remove the drug or alert the users and prescribers.
Experts and researchers warn that the new FDA system may not be enough, stating that considering the size and scope of the plan, “its fruits would take years to realize.” Also, the use of Medicare records only allows for a specific demographic to be review: seniors. Additionally, Medicare only collects the needed data if a person files a claim, which is not always the case. Clearly, the new system is a step in the right direction, but much more needs to be done to prevent the release of drugs which prove eventually dangerous and fatal, and whose risks are known too late.
If you or a loved one has suffered serious side effects or death from prescription drugs in California, please seek the advice of an attorney. You may be entitled to compensation for your pain and losses. Call the Law Offices of The Rudman Law Firm, PLC LLP at 1-800-ALAWPRO (1-800-252-9776) now for a free and confidential consultation. We have over 50 years combined experience in representing the rights of the injured. Call us now and let us do the work and worrying for you.
