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On September 22, Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics, agreed to plead guilty to two counts of violating the Federal Food, Drug, and Cosmetic (FD&C) Act related to the company’s introduction of misbranded Juxtapid (lomitapide).
Along with the guilty pleas, Aegerion agreed to pay a fine of $40.1 million to the Justice Department and the Security Exchange Commission (SEC), and will enter into a consent decree of permanent injunction with the U.S., which includes participating in a comprehensive FDA compliance program to ensure that the company follows the law.
Yearly treatment with this drug costs $200,000 to $300,000, and along with the hefty price a black box warning of serious side effects related to liver toxicity.
Juxtapid can also increase liver fat, which may lead to a condition known as hepatic steatosis, a risk factor for progressive liver disease.
Due to the risk of liver toxicity, the drug is only available from certified doctors and pharmacies through a special program called the Juxtapid Risk Evaluation and Mitigation Program.
Court documents indicated that the company tried to market the drug indirectly to non-HoFH patients, even though the drug’s approval included a requirement that Aegerion educates doctors about the risks associated with Juxtapid use and that the medication should only be used for patients with a clinical or laboratory diagnosis of HoFH.
There was also evidence that the company was using a definition of HoFH that was not consistent with Aegerion’s pre-approval filings with the FDA and did not match any peer-reviewed clinical standard for diagnosing HoFH.
In addition, Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program, according to the FDA.
The U.S. Food and Drug Administration (FDA) approved the drug in December 2012 for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare genetic condition in which patients cannot reduce their LDL or “bad” cholesterol levels with conventional treatment methods.
The condition appears at birth and can cause cardiac disease in patients even before they reach their teenage years.
On July 28, the FDA approved labeling changes for Juxtapid to reflect new risks of myalgia and alopecia associated with the medication.
Alopecia has been reported 27 times by Juxtapid patients, and two individuals were hospitalized due to their conditions.
Seventy-three patients reported myalgia with Juxtapid use, with four resulting in hospitalization and two in disability.
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With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three. She spent the first decade of her career working as an international tax attorney at Deloitte.
In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.
In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!
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Camp Lejeune’s water contamination issue spanned several decades starting in the 1950s. Exposure to these chemicals has been linked to various serious health issues, including cancer, organ diseases, and death.
Research is increasingly suggesting a link between the use of Tylenol during pregnancy and the development of neurodevelopmental disorders, such as autism and ADHD, in infants.
Legal action is being taken against manufacturers of Aqueous Film-Forming Foam (AFFF), a chemical used in fighting fires. The plaintiffs allege that exposure to the foam caused health issues such as cancer, organ damage, and birth and fertility issues.
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
According to the FDA, 20-ounce packages of “King Kullen Broccoli Cutlets with Bread Crumbs and Parmesan” have been recalled by New Haven, Connecticut-based Gracie’s Kitchen due to the potential presence of undeclared sesame and wheat. Individuals who live with allergies to either allergen are advised
The FDA is warning consumers of a Class I recall of Boston Scientific’s Obsidio Comformable Embolic because the device has been shown to present a risk for increased bowel ischemia when used for lower GI (gastrointestinal) bleeding, or acute colonic bleeding. As a pre-mixed embolic
Animal nutrition business Cargill has announced a recall of Nutrena Country Feeds Meat bird 22% Crumble (RV) because the product after the product was found to be missing Vitamin D, according to the FDA. Growing birds who consume a diet lacking in the vitamin can