Dangerous Drugs

Medical advances have made the ability to take prescription drugs a miracle for millions of people. However, some dangerous medications can cause serious complications, or even death, for those who take them.

According to a study by the Mayo Clinic and Olmsted Medical Center, 70% of Americans regularly take at least one prescription drug, with more than half taking two. Essentially all drugs carry the risk of side effects. However, in most cases, the risks the drug may pose are greatly outweighed by the benefits that it provides. Some drugs have very little risk of adverse effects, while some have a higher risk, but may be necessary to treat life-altering or debilitating conditions.

If a drug’s risk of harm outweighs the benefits of its use, then the drug may be considered dangerous. A drug can also be considered dangerous if it is sold without sufficient warnings about potential side effects, drug interactions, or other risks associated with its use.

How Dangerous Drugs Are Recalled

Recalling a drug can be a complicated and lengthy process. The FDA does not have unilateral authority to recall a dangerous drug by itself, but the FDA can recommend to the manufacturer of the dangerous drug that it is recalled. At that point, it is the drug manufacturer’s responsibility to initiate and execute the recall. However, the FDA does have the authority to mandate the recall of a defective or dangerous medical device.

When Does the FDA Issue a Recall?

The process of recalling a dangerous drug involves several steps. First, the FDA will conduct a health hazard evaluation, where a specific committee of scientists is assembled. In this evaluation, the scientists will consider:

  • The drug’s relative risk to the general population as well as the risk it may pose to special segments such as the elderly, children, or those who are pregnant
  • Any reported side effects, diseases, or injuries the drug may have caused
  • Pre-existing conditions that could be contributing factors
  • The severity of the health hazard and the risk level to those exposed
  • The consequences of immediate use as well as long-term health hazards posed by the drug

Recall Classifications

Class 1 Recall

Class 1 recalls are the most serious recalls. When a class 1 recall is issued, there is a reasonable probability that the dangerous drug or device could cause users to suffer serious injury/illness or death. Class 1 recalls can be implemented even for life-saving drugs and medical devices like pacemakers.

Class 2 Recall

The majority of dangerous drug or medical device recalls are class 2 recalls. This means the product may cause temporary or reversible adverse events. Most medical implants, like hip and knee implants, fall in the class 2 recall category. While typically not life-threatening, injuries from class 2 drugs or medical devices can still be very serious.

Class 3 Recall

By contrast, a class 3 recall applies to drugs that are least likely to cause the user an illness or injury, but may still have recently discovered issues. An example would be a minor defect with the medication’s packaging.

There are many separate parties involved when it comes to the manufacturing, production, and distribution of a pharmaceutical drug. Each party is responsible for following the full extent of the FDA’s guidelines.

When a drug, prescription, or over-the-counter product causes harm, the patient can file a dangerous drug claim against the potentially liable party for negligence, strict liability, or failure to warn. An experienced dangerous drug attorney can help you determine what kind of claim to file, as well as who may be at fault for your injuries or for the death of a loved one.

Potentially liable parties may include:

  • Drug manufacturers
  • Drug distributors

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Every year, roughly 1.3 million emergency room visits are attributed to adverse drug events.

According to the CDC

Commonly Dangerous Drugs

Every medication comes with some risk of developing side effects. However, some pharmaceutical drugs have caused complications that are so severe that they outweigh any health benefits they may offer.

What makes these drug complications particularly dangerous is when the manufacturer fails to warn about them. There have even been cases when pharmaceutical companies intentionally suppress research that shows the risk for developing serious health conditions. When this occurs, patients can often fight back by filing a product liability lawsuit.

 

Elmiron

Elmiron is a prescription drug that treats bladder pain associated with interstitial cystitis. However, it has been linked to severe eye damage.

Zantac

An over-the-counter drug used to treat indigestion and heartburn, Zantac has recently been linked to an increased risk of cancer.

Pradaxa

A blood-thinning medication, Pradaxa has been linked to an increased risk of uncontrollable internal and external bleeding.

Nexium

This common proton pump inhibitor drug has been linked to multiple possibly fatal conditions, including kidney disease.

What to Do if You’ve Been Harmed

If you believe your medication is causing dangerous side effects, contact your doctor immediately. They may recommend that you stop taking the medication and / or prescribe a different drug to you.

You should also consider talking with your doctor about reporting the incident to the FDA. This can help ensure that other physicians are fully aware of the potential risks of the medication prior to prescribing it to their patients.

Lastly, filing a lawsuit can help hold any negligent pharmaceutical companies accountable if they failed to warn of the dangerous complications the medication may have caused.

Legal Action

Due to the complexity involved in product liability and dangerous drug claims, it is imperative to consult with an experienced dangerous drug attorney to help you understand your options and the best course of action. An experienced dangerous drugs lawyer will help determine who may be liable, build your claim with expert testimony, and advocate on your behalf in order to help you receive the maximum compensation you may be entitled to.

Contact MedFault

If you or a loved one was the victim of an illness or injury due to a dangerous drug or medical device, contact MedFault to set up a free legal consultation with a skilled product liability attorney who can help you understand your options.