Judge orders Ely Lilly to unseal Zyprexa documents
NEW YORK A judge in the United States District Court for the Eastern District of New York said Friday he would unseal documents concerning Zyprexa, Eli Lilly’s schizophrenia drug.
Judge Jack Weinstein’s ruling was related to his granting of class-action status to a group of unions, pension funds and insurance companies alleging that the Indianapolis-based drug maker failed to disclose some of the drug’s side effects and marketed it for uses for which regulators had not approved it.
The documents date back to 2004, when several patients sued Lilly, alleging that Zyprexa (olanzapine) caused them to develop diabetes and gain excessive weight.
FDA increases drug warnings for TNF blockers
WASHINGTON A risk of fungal infection has prompted the Food and Drug Administration to call on four drug makers to strengthen warnings on some of their products.
Johnson & Johnson’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab), Amgen’s and Wyeth’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol) are the drugs affected after the FDA reviewed 240 reports of the respiratory fungal disease histoplasmosis in patients using the drugs. Of the 240 patients, 45 died from the disease, whose symptoms resemble those of the flu.
The drugs belong to a class of drugs that block tumor necrosis factor, which normally helps the body fight cancer but is sometimes overproduced, leading to diseases such as arthritis and Crohn’s disease.
“Amgen and Wyeth are committed to the safety of patients,” the companies said in a jointly released statement Friday. “Both companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports from controlled and open-label clinical trials and patient registries, as well as reports received from health care professionals and patients. Both companies work with regulatory agencies to update the label periodically as appropriate based on emerging information.”
Amgen, they stated, will work with the FDA to finalize and communicate revised product labeling for Enbrel to both physicians and patients.
FDA posts first quarterly drug safety report
WASHINGTON The Food and Drug Administration has posted its first quarterly report on drugs under review for possible safety issues, the agency announced Friday.
The drugs are identified based on a review of reports in the FDA’s Adverse Event Reporting System and are listed under the Food and Drug Administration Amendments Act of 2007, which requires the FDA to inform the public of new safety information or potential signals of serious risk, based on reviews of AERS.
But, the FDA cautioned, a drug’s appearance on the list doesn’t mean it definitely carries the risk only because the FDA has identified a potential safety issue.
“My message to patients is this: Don’t stop taking your medicine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”