What Is a Risk Evaluation and Mitigation Strategy?
When the Food and Drug Administration issues a black box warning, it requires manufacturers to follow additional steps that make up a risk evaluation and mitigation strategy, or REMS. While the black box label acts as a strong warning to patients and physicians alike, it may not be sufficient to inform consumers about the dangers of their medications. The addition of a mitigation strategy helps to increase patient awareness.
Contact the Reglan attorneys of Williams Kherkher at 800-761-3187 today for more information regarding your rights and options if Reglan’s adverse effects have made you suffer.
Reglan’s REMS
In 2009, the FDA issued a black box warning for the heartburn and gastrointestinal medication Reglan. This drug causes the nervous system connections between the body’s muscles and the brain to become damaged. As a result, a person can develop uncontrollable spasms in the face, neck, and limbs. In addition to the warning, the FDA issued a strategy to:
- Inform patients about the adverse side effects of Reglan
- Inform patients about the dangers of chronic Reglan use
- Promote discussion between doctors and patients
The risk evaluation and mitigation strategy in the case of Reglan has primarily aimed to increase education and awareness of the drug’s potentially devastating side effects.
Contact Us
If you have developed a debilitating neuromuscular disorder because of Reglan use, you may be eligible to pursue litigation. To discuss your claim in detail with a legal advisor, contact the Reglan lawyers of Williams Kherkher today by calling 800-761-3187.
What Is a Risk Evaluation and Mitigation Strategy?
When the Food and Drug Administration issues a black box warning, it requires manufacturers to follow additional steps that make up a risk evaluation and mitigation strategy, or REMS. While the black box label acts as a strong warning to patients and physicians alike, it may not be sufficient to inform consumers about the dangers of their medications. The addition of a mitigation strategy helps to increase patient awareness.
Contact the Reglan attorneys of Williams Kherkher at 800-761-3187 today for more information regarding your rights and options if Reglan’s adverse effects have made you suffer.
Reglan’s REMS
In 2009, the FDA issued a black box warning for the heartburn and gastrointestinal medication Reglan. This drug causes the nervous system connections between the body’s muscles and the brain to become damaged. As a result, a person can develop uncontrollable spasms in the face, neck, and limbs. In addition to the warning, the FDA issued a strategy to:
-
Inform patients about the adverse side effects of Reglan
-
Inform patients about the dangers of chronic Reglan use
-
Promote discussion between doctors and patients
The risk evaluation and mitigation strategy in the case of Reglan has primarily aimed to increase education and awareness of the drug’s potentially devastating side effects.
Contact Us
If you have developed a debilitating neuromuscular disorder because of Reglan use, you may be eligible to pursue litigation. To discuss your claim in detail with a legal advisor, contact the Reglan lawyers of Williams Kherkher today by calling 800-761-3187.
