Tag: Rems

Approximately 20-30% of patients with schizophrenia are considered treatment-resistant, failing to respond to standard therapies [1.6.6, 1.6.7]. For these individuals, the crucial question is, **what class does clozapine belong to?** It is a unique atypical antipsychotic, recognized as the gold standard for this challenging condition [1.2.2].

The Food and Drug Administration (FDA) mandates that medications with potentially life-threatening side effects display a black box warning, the most serious warning it can issue. A prominent black box warning on Brixadi highlights the significant risk of serious harm or death if the subcutaneous injection is administered intravenously instead.

Sublocade, a buprenorphine injection, has a boxed warning from the FDA due to the risk of serious harm or death if administered intravenously [1.3.1, 1.3.2, 1.3.3]. So, what happens if Sublocade is injected wrong, and why are the consequences so severe?

Medication abortion using mifepristone accounts for roughly two-thirds of all abortions in the U.S.. Despite the high prevalence, access to the drug is strictly regulated, which raises the question: does mifepristone need to be prescribed? The definitive answer is yes; it is not an over-the-counter medication and is only available through a highly controlled distribution system.

In 1975, a cluster of patient deaths in Finland shocked the pharmaceutical industry and led to the dramatic withdrawal of the groundbreaking antipsychotic, clozapine, from the market. This initial safety scare is why was clozapine taken off the market, forever changing the drug's regulatory path and perception, despite its eventual reintroduction under stringent safety protocols.

According to the U.S. Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), Adempas (riociguat) is not classified as a controlled substance. Despite its non-controlled status, the drug is subject to stringent distribution controls due to its significant risk of embryo-fetal toxicity.

According to the Pulmonary Hypertension Association, treatments for the rare and serious condition of pulmonary arterial hypertension (PAH) often involve medications that have a unique distribution and handling process. Among these is Letairis (ambrisentan), and for those asking, 'Is Letairis a specialty drug?', the answer is definitively yes. The classification is due to its specialized nature, high cost, and the strict safety monitoring required by the FDA.

Did you know that only a small percentage of FDA-approved medications require a Risk Evaluation and Mitigation Strategy (REMS)? What is REMS? It is a specialized drug safety program mandated by the U.S. Food and Drug Administration (FDA) for certain high-risk medications to ensure their benefits outweigh their risks.