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The Purpose Of Black Label Warnings For Medicine

When a household cleaner, automotive liquid, or other such toxic substance can cause severe harm to humans, it carries the skull-and-crossbones symbol in order to show that it is poisonous. However, when a medication causes dangerous side effects, it carries a Black Label Warning or a Black Box Warning.

The Food and Drug Administration, or FDA, is in charge of regulating the safety of medications. When a pharmaceutical company produces a new drug, the manufacturer itself is in charge of going through several different levels of testing in order to determine the safety of the substance. Finally, when they are sure that it is safe, they apply with the FDA to put the drug on the market. The FDA will then perform testing as well to double-check the results of the trials performed by the pharmaceutical company. It is only once the FDA determines that the product is safe that it can be prescribed.

Sometimes, dangerous drugs can slip past the FDA because they may not think to test a certain group of people. An example of this is thalidomide. During testing for this drug, no one thought to try the medication on pregnant women. The FDA assumed it was safe and allowed it to be prescribed to thousands of pregnant women in order to alleviate their morning sickness. Sadly, it was not until after this accidental testing that they discovered the terrible effects of thalidomide. In the womb, the drug caused genetic mutations that shortened or even eliminated a fetus' arms and legs.

Other times, the hazardous side effects of a medication may not show up immediately after testing. For example, Reglan, a drug containing the ingredient metoclopramide, was originally put on the market to treat chronic acid reflux disease and severe heartburn. While Reglan does perform as it should, it can also permanently disrupt the connections between your nerves and muscles. This results in neuromuscular disorders such as tardive dyskinesia and cervical dystonia.

However, rather than completely take Reglan off the market, the FDA decided to issue a Black Label Warning. This is the strongest warning that the FDA can give without completely removing a drug from the market. The purpose of the Black Box is to inform a potential consumer of the risks associated with the medication and the severe, permanent side effects that it can cause.

While the FDA has not yet chosen to take Reglan away completely, the Black Label serves as a warning to consumers. Thus, it is your choice whether to take Reglan and risk the neuromuscular disorders, or skip the drug and try to solve your acid reflux in a less dangerous way.

For more information regarding the risks associated with Reglan, contact the Reglan attorneys from Williams Kherkher today.

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