The Food and Drug Administration (FDA) is facing another round of criticism for what some public health advocacy groups consider an inability to respond to the dangerous side effects associated with some prescription medications. Although prescription drugs play a crucial role in the fight against diseases, they can have unintended and unexpected side effects. In many cases, the full extent of these side effects are not known until the product has been used extensively, which often only occurs after the drug is released widely to the public.
Unfortunately, this often means that the public can end up serving as a study group. Although this may be unavoidable in some situations, because some side effects are simply not apparent until the medication is used widely or for a significant period of time, some public health advocacy groups question the FDA’s ability to monitor the presence and danger of side effects as they become apparent.
The Institute of Medicine’s Response
An independent research group studied the FDA’s response to these situations and recently released a report on its findings. The study, conducted by The Institute of Medicine (IOM), focuses on the FDA’s ability to report and review the dangers and defects associated with these medications.
The IOM insists that the FDA should “use a consistent process for evaluating information about the benefits and risks of drugs” while they are on the market and available to the public. The researchers recommend that the government body implement a comprehensive document following medications throughout their “lifecycle” on the market.
The need for this tracking database was highlighted by the recent high-profile failures of Vioxx, a painkiller and Avandia, a Type 2 diabetes medication. Both medications were found to greatly increase the patient’s risk of heart attacks and strokes after released for public use.
Vioxx was prescribed in the U.S. for five years, even though the FDA was “concerned and aware of the potential for cardiovascular effects” for years before the drug was pulled from the market. The medication was linked to more than 27,000 sudden deaths and heart attacks while it was on the market.
Avandia, once the top selling diabetes drug, was linked to almost 47,000 cases of heart attack, stroke or death. The drug was released for public use in 1999. In 2007, the FDA reviewed studies which determined that the medication greatly increases the risk of heart attacks. It ultimately decided to implement a stringent set of restrictions on the drug’s use in the United States, while European officials decided to completely remove the drug from the market.
The IOM has also recommended that their proposed drug “lifecycle” document be available to the public. The FDA is not required to follow the IOM’s recommendations, and has expressed concerns that developing and maintaining such a system would be too costly. However, the benefits to patients and the likely decrease in health care costs needed to care for patients suffering from unexpected side effects may justify the system’s expenses.
Benefits of Public Access to Information on Potential Dangers of Prescription Drugs
Currently, the FDA is required to check for safety issues after a drug has been used by 10,000 patients or has been on the market for 18 months, whichever occurs later. If safety issues are reported by manufacturers, doctors or patients, further research may be called for.
The IOM’s program would require the FDA to keep a closer watch on how prescription medication is received by the public. It would require a public reporting method for any dangerous side effects that are experienced while the drug is on the market.
For better and worse, this type of “post-approval monitoring is critical because safety concerns with a drug may only become apparent once it has been used for many years, and by thousands of patients,” the director of the Johns Hopkins Berman Institute of Bioethics recently told Reuters.
Implementation of the IOM’s recommended tracking system would allow patients access to critical information. The Centers for Disease Control and Prevention estimates that 48 percent of all Americans take at least one prescription medication drug.
How a Database Could Improve Patient Safety
The FDA already has the authority to require post-marketing clinical trials under certain conditions. The FDA has an ethical duty, as a public health agency, to protect the public from unsafe medicines. According to the IOM, the FDA’s current system “does not ensure that it assesses the benefits and risks of drugs consistently over a drug’s life cycle.”
As a result, faulty drugs are not only reaching the market but are continuing to be prescribed well after dangerous side effects are known to exist. Until the FDA implements a system to better recognize the risks associated with medications and share the information as it becomes known, this potentially lethal problem will continue.
If a problem is known, the manufacturer has a duty to warn of side effects. Since manufacturers are considered to be experts in their field, they are required to keep current of any new information relating to their products. If this duty is breached, the manufacturer may be held liable for any injuries which result.
Philadelphia Medical Malpractice Lawyers at McCann Dillon Jaffe & Lamb, LLC Help Victims Injured By Dangerous and Defective Drugs
If you or a loved one is injured by a defective medication, compensation may be available to cover medical and rehabilitative expenses as well as pain and suffering. Every situation is unique. It is important to contact an experienced personal injury attorney to discuss your situation and better protect your legal rights and remedies. Contact McCann Dillon Jaffe & Lamb, LLC today at 215-569-8488 or 302-888-1221 to schedule a free initial consultation with one of our experienced Philadelphia medical malpractice lawyers. You may also contact us online. We offer legal representation to injured victims and families in Pennsylvania, New Jersey and Delaware.