The FDA has warned that lamotrigine (Lamictal, GlaxoSmithKline), which isindicated for treating seizures and bi – polar disorder, can cause aseptic meningitis. The agency is working with the company to update the prescribing information and the patient medication guide. A rare but serious side effect of lamotrigine use, aseptic meningitis can also be caused by viruses, toxic agents, some vaccines, and autoimmune disease. Symptoms may include headache, fever, chills, nausea, vomiting, stiff neck, and sensitivity to light. When meningitis is suspected, lamo – trigine should be discontinued if no other cause of meningitis is identified.
The drug was approved in December 2004. Since then and continuing through November 2009, 40 cases of aseptic meningitis have been identified in patients taking the product. Of these 40 patients, 35 needed hospitalization. Symptoms generally resolved after the drug was discontinued. In 15 cases, even more severe symptoms returned when patients resumed taking the drug.
Source: FDA, August 12, 2010
SSRIs Lack Benefit for Autism
Antidepressants commonly prescribed to people with autistic spectrum disorders should not be recommended at this time, according to a new study. Despite some evidence of benefits in adults with autism, there appears to be no evidence for any benefits associated with selective serotonin reuptake inhibitors (SSRIs) in children, who may experience serious adverse drug effects. Although SSRIs are widely prescribed, they have not been specifically approved for use in autism. In the U.K., most antidepressants are not approved for children for any condition. The rationale behind the use of SSRIs in autism is that they act on serotonin, which affects some of the psychological processes affected by the condition.
Cochrane researchers included seven trials of 271 patients in their study. They evaluated fluoxetine (Prozac, Eli Lilly), fluvoxamine (Luvox, Solvay), (Celexa, Forest), and fenfluramine (removed from the U.S. market). Overall, the investigators found no benefit in the five trials in children and did find some evidence of serious harm, including one child who had a prolonged seizure after taking citalopram. In the two trials for adults, symptoms improved, but there was too little evidence for the drugs to be recommended. A problem with analyzing the results was that each trial used different measures for assessing the drugs’ effects. The researchers said that decisions about using SSRIs for coexisting obsessive-compulsive disorder, aggression, anxiety, or depression in patients with au tism could be made on a case-by-case basis.