What does Actos’ “black box” warning label mean?
If you’re taking Actos for type-2 diabetes in Florida, you’ve probably been overwhelmed by warnings. Friends and family members no doubt send you emails and news clippings, warning you that even the US Food and Drug Administration doesn’t think Actos is safe.
But does the “black box” label really mean Actos is life-threatening-or just for some patients?
A “black box” label is the FDA’s highest possible warning on a drug. It signifies extreme side effects, and is the most severe action the FDA can take against a medication short of recall. It is also called a “boxed label” because it is typed in large letters with a box around it on the package and information insert.
Generally, when the FDA issues a black box label, the number of patients taking the drug goes down significantly. While they have not yet removed Actos from the market, the FDA can at least limit the number of patients at risk to diabetics who are most likely to benefit.
A few facts about the FDA “black box” label:
- Drugs are required to carry boxed labels if they have been proven to cause disabling or potentially fatal side effects.
- Hundreds of drugs on the U.S. market carry a black box label, ranging from simple pain relievers to anti-psychotics.
- Although Actos use has been linked to bladder cancer, bone fractures, liver damage and heart failure, the black box warning on its package only warns against heart-related side effects.
- Since the risk of harmful side effects increases drastically in at-risk patients, your doctor must discuss Actos with you before prescribing to determine if your own benefits outweigh the risks.
As trusted Palm Beach Actos lawsuit attorneys, we know that all drugs have side effects. But if you are putting your life at risk every time you take a medication, the drug company can be held responsible for causing you unnecessary harm.
Don’t let a disreputable drug company gamble with your health! Call Fetterman & Associates today at (888) 819-4770 for a free consultation.
