Eli Lilly updates product labels
INDIANAPOLIS Eli Lilly has updated the U.S. product labels for two of its patented medications, the company announced Friday.
As part of its ongoing discussions with the FDA, the company has updated its labels for Zyprexa and Symbyax. Both medications, which are used to treat mental disorders, were shown to pose a threat to patients, according the company’s clinical trial data. The risks included potential weight gain and elevations in blood sugar and lipid levels, although they had been previously listed on the drugs’ warning labels since they entered the pharmaceutical realm.
Lilly said it would be communicating the updates to U.S. physicians through a “Dear Healthcare Practitioner” letter. The company also said in a press release that they would be notifying “consumer advocacy and professionally focused associations about this label change so they can provide important information to patients.” In addition to the outreach to various health organizations, Lilly added that it is in the process of corresponding the data involved with the updates to regulatory agencies outside of the United States.
“Today’s communication is part of Lilly’s historical and ongoing commitment to inform doctors and patients about updated prescribing information,” said Sara Corya, M.D., global medical director, Lilly. “Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression. This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients.”
In the meantime, new labeling information was released on the products’ Web sites.
FDA increases potency of levothyroxine products
WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.
The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.
Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.
Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.
FDA to review heart problems from osteoporosis drugs
WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.
Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.
The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.
The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.