Ten Drugs Make New FDA Watch List

Source: Ten Drugs Make New FDA Watch List

Side effects under investigation.

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Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease — NEJM

Conclusions: Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; HOPE-3 ClinicalTrials.gov number, NCT00468923.)

Source: Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease — NEJM

Source: Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease — NEJM

Source: Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease — NEJM

FDA Stiffens Warning on NSAID Cardiovascular Risk | Medpage Today

FDA Stiffens Warning on NSAID Cardiovascular Risk | Medpage Today.

Thought I would add a link to the actual FDA alert.

via Safety Alerts for Human Medical Products > Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication – FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

PCSK9 Inhibitors

There’s also the issue of cost. The medicines are expected to come with a price tag of $7,000 to $12,000 per patient per year, according to the Wall Street Journal’s Pharmalot blog, costing the US health system as much as $23 billion a year. “These injectable drugs are already viewed by payers as potential budget busters along the lines of treatments for hepatitis C and some cancers,” Ed Silverman wrote.

via There’s still a lot we don’t know about the new cholesterol-lowering drugs – Vox.