FDA rejects Novartis’ Cox-2 Inhibitor, Prexige
WASHINGTON The U.S. Food and Drug Administration announced that it has rejected Novartis’ once-daily treatment for pain caused by osteoarthritis, officials said Friday.
Novartis has received a not-approved letter from the FDA for its Cox-2 inhibitor Prexige as a once-daily treatment for osteoarthritic pain.
Though the FDA did not approve the use of the drug in the U.S., the organization said it would consider the use of Prexige for patients in whom the drug would provide an acceptable risk-benefit balance.
The drug is approved in more than 50 countries, Novartis said.
Recently, regulatory authorities of several nations have been questioning the safety of Prexige because of reports that patients consuming the drug had suffered from severe liver damage. Australia’s Therapeutic Goods Administration withdrew the drug, while New Zealand regulators withdrew the 200- and 400-mg tablets. Canadian authorities have announced plans to review the drug’s safety.
At the FDA’s request, Novartis submitted clinical data on the liver profile of the proposed 100-mg dose studied over 12 months of therapy. The results showed 0.85 percent of patients had elevations of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) of greater than three times the upper limit of normal, which is similar to levels observed with currently available medication, the company said.
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.