Statins not linked to ALS
A new FDA analysis offers evidence that using HMG-CoA reductase inhibitors (statins) does not increase the risk of amyotrophic lateral sclerosis (ALS). The agency started the review in 2007 after receiving a higher-than-expected number of Adverse Event Reporting System reports of ALS in patients on statins.
The analysis is based on data from 41 long-term controlled clinical trials. The results show no increased incidence of ALS in patients treated with a statin compared with a placebo.
The FDA documented that during the course of long-term, placebo-controlled clinical trials, nine of approximately 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. The incidence of ALS in patients treated with a statin was 4.2 cases per 100,000 patient-years, and the incidence of ALS in patients treated with a placebo was five cases per 100,000 patient-years.
Although the agency finds the lack of an increase in the incidence of ALS with statins reassuring, it will continue to study the issue given the extensive use of this class of drugs.
The FDA anticipates the completion of a case-control study of ALS and statin use to be available within 6 to 9 months.
Patch approved for chemo-induced nausea
The FDA has approved ProStrakan Group's granisetron transdermal system (Sancuso), the first patch to provide up to 5 consecutive days of nausea and vomiting control for patients receiving a moderately or highly nausea- inducing chemo therapy regimen.
The FDA approved Sancuso for the prevention of chemotherapy- induced nausea and vomiting (CINV) based on the results of a study comparing the efficacy, tolerability, and safety of Sancuso with once-daily oral granisetron. The drug was generally well tolerated and the study met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron.
The most common adverse reaction to Sancuso was constipation. Application site reactions were reported, but were mild and did not lead to discontinuation of use.
Keppra XR approved as adjunctive therapy
UCB's levetiracetam extended-release tablets (Keppra XR) were approved for use as an add-on therapy to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older with epilepsy.
According to UCB, clinical trial data supported the drug's efficacy and tolerability. Keppra XR provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs.
In clinical trials, adverse reactions included somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR in combination with other antiepileptic drugs were somnolence and irritability.
Keppra XR should be gradually withdrawn to minimize the potential of increased seizure frequency. Dosing must be individualized according to the patient's renal function state.
UCB is initiating a copay support program in the United States to ensure patient access to the drug.
FDA warns about BSS and papain products
The FDA announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. The agency is taking these actions due to reports of serious adverse reactions associated with BSS use.
The companies must stop shipping these unapproved products on or before January 21, 2009.
The FDA also imposed a deadline on companies marketing any unapproved topical drug products containing papain, and the products must cease shipment on or before January 21, 2009. There are no topical drug products containing papain that are approved by the FDA.