Product News and Recalls

FDA Issues Safety Announcement for New Liver Disease Drug

fda issues statement on OcalivaBloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.

Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken by patients. Potential effects of an incorrect dosage include organ failure and death “if it’s not used exactly as intended.” At this time, reports indicate that at least seven of the 19 patients who died from Ocaliva were taking a higher dosage than recommended.

Death is not currently listed as a potential risk on the drug’s packaging, but the recent news could result in more severe warning labels being ordered. Market analyst Joseph Schwartz even says it “could tilt the FDA more toward a black box warning,” which is the most severe that the agency can require. Other products that the FDA has issued black box warnings for in the past include Bayer’s Essure contraceptive device, about which they had received more than 10,000 complaints from consumers, and the practice of prescribing opioid painkillers for children under 18 years of age.

Roughly 15,000 prescriptions have been written for Ocaliva since it hit the market. Currently, Intercept is in the final stages of testing to expand the drug’s use to those with nonalcoholic steatohepatitis, or NASH, which is related to being overweight and affects as much as 12% of the American population. If the corporation gains approval of Ocaliva as a treatment for NASH, analysts have predicted it would generate more than $1 billion in sales by 2021. That would make it a “blockbuster” drug, putting it in the same monumental company as Lipitor and Viagra.

However, the inclusion of additional warnings could prevent that from happening, and Intercept’s stock value has already dropped nearly 25% since the FDA’s safety announcement about Ocaliva. The sharp decline accounts for the corporation’s biggest loss in three years.

Ocaliva is yet another in a long line of drugs found to carry potentially grave risks to patients well-after being approved by the FDA. It could put millions more at risk if approved as a weight loss medication, thus making it critical to monitor its market penetration and usage as more becomes known about the danger it presents to consumers. Unfortunately however, this is still too little too late for those who have already lost their lives.