Ohio Dangerous Drug Attorney

Dangerous Drug Recall Process

In order to be permitted to enter the market, prescription drugs must be rigorously tested and analyzed. According to the U.S. Food and Drug Administration (FDA), when a drug maker wants to produce a medication, they must first submit a new drug application to the Center for Drug Evaluation and Research (CDER). While a team of physicians, chemists, pharmacologists and other professionals from the CDER will review the medication, it is up to the drug company to thoroughly test the drug and provide evidence that it is safe and effective for use.

When a drug poses a health risk, the FDA or the manufacturer of the medication may issue a recall. Also, if it is discovered that a medication causes problems when it is taken in combination with a particular type of vitamin, certain foods or another drug, a recall may be issued. Additionally, a drug might be recalled if an error occurred during the manufacturing process that makes the medication unsafe to use.

The Cleveland Clinic states that drug recalls can be divided into three different categories, which include the following:

• Class I Recall—when a Class I Recall is issued, a medication is pulled from the market after it is discovered that using it will result in serious health consequences or death.
• Class II Recall—a drug may undergo a Class II Recall if it is determined that the medication may cause temporary health problems. This type of recall may also occur if a medication can cause adverse health consequences, but the possibility of this occurring is unlikely.
• Class III Recall—this type of recall is the least serious, and occurs when the use of a drug is not likely to cause problematic health issues.

According to ABC News, in a study conducted at the Brigham and Women’s Hospital in Boston, researchers discovered that Class I recalls, and drug recalls in general, are extremely common. After reviewing FDA records of medication recalls that occurred between 2004 and 2011, the researchers found that of the 1,743 recalls that happened, 91 were categorized as Class I.

Bad Drug Risks

There are other situations where a drug might cause dangerous side effects. In order to remain on the market, drug makers that manufacture drugs that may cause side effects must disclose this information so that it is readily available to consumers. Patients, in conjunction with their medical provider, can then weigh the benefits of taking the medication over the side effects it might cause.

Additionally, in some cases, a drug may be marketed for “off-label” use. According to the National Center for Biotechnology Information, off-label use refers to situations where a drug is taken for a different purpose than it’s intended for, or a dosage or dosage form is used that has not yet been cleared by the FDA. Although off-label use occurs in all specialties of medicine, it is most likely to occur in situations where certain groups of patients are not included in clinical trials.

Attorneys are alleging serious injuries and other complications in Ohio dangerous drug lawsuits being filed on behalf of affected patients.