Today, the FDA updated its Medication Guides page.
According to the FDA:
Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
- certain information is necessary to prevent serious adverse effects
- patient decision-making should be informed by information about a known serious side effect with a product, or
- patient adherence to directions for the use of a product are essential to its effectiveness.
Below are the drugs that have recently been updated:
- Abilify (aripiprazole)
- Abilify Maintena (aripiprazole)
- Effient (prasugrel)
- Farxiga (dapagliflozin)
- Lexapro (escitalopram oxalate)
- Lotronex (alosetron hydrochloride)
- Simponi Aria* (golimumab)
- Simponi* (golimumab)
- Technivie (ombitasvir, paritaprevir and ritonavir tablets)
- Viekira Pak ((ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
