Where Can You Find FDA Warnings About Defective Drugs?

Defective drugs are, unfortunately, a very real concern for patients across the United States. While pharmaceutical companies have an obligation to ensure that their drugs are reasonably safe and provide adequate warnings when necessary, they often don’t do what is required. In many cases, pharmaceutical companies buy generic drugs from foreign manufacturers as well, and there have been numerous reported instances of these manufacturers falling far short of meeting the FDA’s standards.

All of this is to say that if you have questions about hiring a defective drug lawyer, you are not alone.

As a patient, knowing whether you took a defective drug isn’t easy. Individuals’ bodies respond to medications differently, and not all side effects are indicative of defects. In fact, it is common for FDA-approved drugs to have known side effects—including potentially serious side effects in some cases. So, how can you make an informed decision about whether to take legal action?

FDA Resources for Patients Who Have Concerns About Defective Drugs

If you have concerns about a defective drug, a good place to start is the FDA’s website. The FDA regularly publishes warnings about defective drugs online. With that said, you should not rely on the FDA’s website exclusively. The FDA can only report on cases of which it is aware—and, typically, this requires a patient or healthcare provider coming forward.

With this in mind, here are some FDA resources that patients (and family members) can use to look for information about defective drugs:

The FDA’s Drug Safety Communications

The FDA’s Drug Safety Communications are intended to provide “important information to patients and health care professionals about new safety issues with the medicines they are taking or prescribing so they can make more informed decisions about treatment.” The FDA has published two Drug Safety Communications so far this year—one about drugs containing carbidopa/levodopa and one about GLP-1 weight loss drugs.

The FDA maintains a full archive of its Drug Safety Communications as well. In many cases, pharmaceutical manufacturers will continue selling defective drugs as they fight patients’ and families’ lawsuits in court, and, in some cases, patients may experience complications (including cancers and other serious illnesses) years down the line. As a result, if you have concerns about a drug you have taken in the past, it will still be well worth learning about your legal rights.

The FDA’s Drug Alerts and Statements

Along with issuing Drug Safety Communications, the FDA also issues Drug Alerts and Statements. These are notices that provide warnings about various types of risks reportedly linked to FDA-approved drugs. Here are a few of the most recent examples:

• FDA Warns Health Care Professionals Not to Use Epinephrine Nasal Solutions from BPI Labs and Endo USA
• FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
• FDA’s Actions to Protect Children from Contaminated Cough Medicine

While the FDA’s Drug Alerts and Statements are relatively few and far between, they are worth searching if you have concerns. With that said, as with all of the FDA resources on this list, if you do not find your drug listed, this does not necessarily mean that it is safe for its intended use.

Drug Safety-Related Labeling Changes

The FDA also maintains an archive of Drug Safety-Related Labeling Changes dating back to 2016. As its name suggests, this archive contains information about modifications to FDA-approved drugs’ warning labels. Pharmaceutical companies are required by law to provide adequate warnings to patients and healthcare providers, and generally speaking, when a pharmaceutical company adds a new warning to one of its labels, there is a specific reason why.

Drug Recalls

Another important resource for patients and family members is the FDA’s running list of Drug Recalls. As the FDA explains, “[a] recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.” There are three classes of drug recalls:

• Class I Recall: “A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
• Class II Recall: “A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
• Class III Recall: “A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

Since recalls require voluntary action by the pharmaceutical companies, a recall is generally indicative of a well-documented concern. There are multiple drug recalls almost every month, with reasons for these recalls ranging from contamination to concerns about newly discovered complications.

What To Do if You Have Concerns About a Defective Drug

For patients and family members who have concerns about defective drugs, it is important to rely on professional medical and legal advice. While some information about drug defects is available on the FDA’s website, this is not all of the information that patients and family members need to make informed decisions.

When defective drugs lead to serious and fatal medical complications, patients and families have clear legal rights. In these cases, the pharmaceutical companies can be held fully accountable for patients’ and families’ financial and non-financial losses. Hiring a lawyer costs nothing out-of-pocket in this scenario, and, in some cases, patients and family members will be eligible to join ongoing mass tort lawsuits.

Do You Have a Claim? Request a Free Consultation with a Defective Drug Lawyer at Searcy Denney

Do you have questions about filing a claim related to a defective drug? If so, our lawyers can provide a thorough assessment of your legal rights, and we can help you make informed decisions about what to do next. To schedule a free, no-obligation consultation with an experienced defective drug lawyer at Searcy Denney, call 800-780-8607 or request an appointment online today.