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Placing black box warnings on drugs isn’t enough

It’s common for individuals with emotional or behavioral health concerns to take psychotropic drugs to help regulate their moods, propensity to act a certain way or address any number of mental health symptoms. These prescription medications are much like any other drug on the market in that patients may experience side effects by taking them. The U.S. Food and Drug Administration (FDA) requires manufacturers to place black box warnings on these drugs to warn patients about the dangers they face by taking them.

Regulators generally require manufacturers to place black box warnings on psychotropic drugs in three primary instances:

  • A special population is at risk: Manufacturers must warn specific populations, such as kids or pregnant women, that they should receive close monitoring when taking a particular drug.
  • The dosage may need to be changed: Federal officials may also have drug manufacturers put a warning on a medication’s packaging to warn consumers that their doctors may need to adjust their dose before they find the right fit for them.
  • There are serious potential side-effects that should be weighed before a drug is taken: They may also require such labeling to remind patients that there are both positives and negatives to taking certain drugs.

Not every psychotropic drug carries a black box warning. Only certain groups of them do.

Ones such as benzodiazepines have warnings on them, letting consumers know they risk overdosing if they take them alongside opioids. Antidepressant manufacturers must warn their consumers about how children and teens may experience increased suicidal thoughts if they take such drugs. Stimulant manufacturers must warn consumers about their increased risk of addiction.

This list is far from exhaustive. There are many different psychotropic drugs that manufacturers must label with black box warnings.

Including such a notice to a consumer on product packaging doesn’t take away these companies’ liability for patients’ outcomes when taking these drugs. It doesn’t reduce the need for doctors to warn patients about the dangers associated with taking them either. An attorney can advise you how Louisiana law allows you to recover compensation if you suffered health declines from taking a prescription drug. Let a local law firm with a national scope take on these manufacturers for you.

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