Posted on September 24, 2012 in Products Liability
The Philadelphia products liability lawyers at Galfand Berger recently reviewed an article that scrutinizes the risks of the accelerated approval program for encouraging new drugs by the Food and Drug Administration (FDA). The article written by two drug-safety experts appeared in a recent edition of the Journal of the American Medical Association (JAMA). According to the JAMA article, for the fiscal year of 2011, the FDA approved 16 out of the new 35 drugs using one of several shortened review processes.
All 16 of the new medications undergoing abridged review processes offered some type of beneficial medical advancement so they qualified for a priority review or condensed review time. In addition, 13 were eligible to be pushed through the fast track program in which the review process was initiated before clinical trials were finished. Lastly, 3 drugs were authorized for the accelerated approval process in which only preliminary evidence proved beneficial but no definitive evidence was available.
Some examples of the drugs cited in the article that were approved through the speedy processes are the cancer drug Caprelsa, the multiple sclerosis drug Gilenya and a stroke prevention drug Pradaxa. Within their report, the drug-safety advocates raise the question of whether the FDA has rushed to approve several new medicines making them available for widespread use without proper safety testing and the potential for causing serious health risks.
Pradaxa: Blood Thinner Approved Through Accelerated Program Linked to Hundreds of Fatalities
Pradaxa is one such drug that was approved through the accelerated process in October 2010. Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc, Pradaxa is an anticoagulant or blood thinner that is used in patients that are diagnosed with a heart arrhythmia known as atrial fibrillation. Pradaxa is used to decrease a patient’s risk of suffering a stroke or blood clots; however, there are risks associated with Pradaxa, such as uncontrollable bleeding even after just a minor trauma such as a cut or bump on the head. There is no antidote available, which means that there is no other substance or medication that can be given to counter the effects of Pradaxa in a bleeding emergency.
Unfortunately, there have been thousands of adverse effects reported with the use of Pradaxa and reports of hundreds of patients dying from a bleeding episode that could not be stopped. Pradaxa is now at the center of hundreds of products liability lawsuits and the number continues to grow. The FDA is continuing to review case reports and claims that when Pradaxa is used in the correct population, the benefits outweigh the risks.
Controversy Surrounding Drug Approval Process
It has been argued that perhaps the FDA could alter their policies in approving new drugs that would better balance the benefits of patient safety and the need for new advanced medications. It has also been suggested that drug companies should be required to provide data on the safety and effectiveness of the drug soon after its approval and if a company fails to comply with these guidelines that the drug will be pulled from the market.
The FDA continues to support their drug approval program. The agency has stated that the public has voiced their willingness to accept the health risks when there are little to no treatment options available to them, particularly those individuals suffering from cancer. In addition, the FDA claims that medical groups have been pushing the agency to move even quicker with the drug evaluation and review process.
Galfand Berger – Philadelphia Products Liability Attorneys Committed to Helping Victims Injured by Pradaxa and other Dangerous Drugs
The patients across this country trust and expect that their doctors will prescribe drugs and medical treatments that are safe. As legal advocates for victims of personal injuries from dangerous pharmaceuticals and medical devices, we believe that manufacturers of these products need to held accountable and support all initiatives that provide safer and more efficient medical products. The distinguished Philadelphia defective drug lawyers at Galfand Berger are concerned about patient safety and the risk of using experimental risky drugs and medical devices that have not been substantially proven to be beneficial through vigorous clinical trials.
If you or someone you love has suffered injuries or a fatality by taking Pradaxa or another medication, or by a defective medical device, please contact the products liability attorneys at Galfand Berger. Our personal injury lawyers in Pennsylvania and New Jersey are experienced at handling all types of cases involving pharmaceutical and medical device injuries. To discuss a potential claim with one of our Philadelphia defective drug attorneys, contact one of our offices that are conveniently located in Philadelphia, Reading and Bethlehem, Pennsylvania as well as Burlington, New Jersey. Call 1-800-222-USWA (8792) to schedule a free and confidential consultation or submit a free online inquiry at www.galfandberger.com.