Juxtapid Maker Gets FDA Warning Letter Over Misleading Statements
The FDA has issued a warning letter to Aegerion Pharmaceuticals, accusing the company of exaggerating the benefits of Juxtapid and promoting the heart medication for unapproved uses.
The FDA warning letter alleges Juxtapid was branded as a drug used to prevent heart attacks and extend the life of the patient. The statements “misleadingly suggest it is safe and effective as monotherapy,” said the FDA letter, for which it is not approved.
Juxtapid (lomitapide) is approved for the use of homozygous familial hypercholesterolemia (HoFH), a rare form of high cholesterol which can lead to heart attack and early death.
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The warning letter was issued in response to two television appearances this year by Aegerion’s CEO, Marc Beer, on CNBC’s ‘Fast Money.’ During the broadcasts Beer made statements about Juxtapid, indicating that the drug could increase a person’s life and protect against heart attack in people who suffer from HoFH.
Beer made several statements asserting the safety and use of Juxtapid as a prevention for heart attack and early death.
“These patients are going to die of a cardiac event, either a stroke or a heart attack, if we don’t have them on therapy,” said Beer during one of the broadcasts.
The FDA cites the product labeling in the letter, saying it “is not known if Juxtapid is safe in people with high cholesterol, but who do not have HoFH” and “the effect of the drug on cardiovascular morbidity and mortality has not been determined.”
Federal officials chastise Beer’s statements, which seem to be in direct contradiction with product labeling concerning the drug.
FDA Questions Juxtapid Marketing Goals
The Office of Prescription Drug Promotion (OPDP) of the FDA indicated that the statements made during the June 5 and October 31 broadcasts suggested the drug is intended for new uses, for which it is not approved.
These statements place Juxtapid in violation of the Federal Food Drug and Cosmetic Act. The FDA indicates that Beer’s statement that the product has the “potential of taking a patient that would die at 30 and allow them to meet their grandkids,” is misleading to patients.
The FDA is also concerned the company did not adequately communicate the drugs risks to patients and misrepresented those risks during television broadcasts and in other product marketing. Severe risks include liver toxicity, risk of embryo fetal-toxicity, reduced absorption of fat soluble vitamins, diarrhea, nausea, vomiting and abdominal pain.
The product is only approved as an adjunct to a low-fat diet and other cholesterol lowering treatments. The FDA did not approve it for stand-alone use.
The FDA is requesting a written response from Aegerion by November 22, to ensure the company will correct any misbranding or false statements made about Juxtapid’s efficacy. The FDA warned the company that if monotherapy is the goal of the medication then its distribution is illegal, since the FDA never approved it for that use. The FDA warned that a failure to respond to the charges could lead to product seizure and injunction.
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