Skip to main content

FDA Relabels Carbamazepine to Recommend Genetic Test for Risk of Skin Reactions

NEW YORK (GenomeWeb News) – Patients of Asian ancestry taking the drug carbamazepine will now be advised to take a genetic test to determine whether they have a heightened risk of developing a rare but serious skin reaction, the US Food and Drug Administration said in a statement today. 
Carbamazepine treats epilepsy, bipolar disorder, and neuropathic pain, and is sold under the brand names Carbatrol, Equetro, and Tegretol by Shire Pharmaceuticals, Validus Pharmaceuticals, and Novartis, respectively.
The FDA said the drug can in some instances cause life-threatening skin reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome, which is characterized by skin lesions, blisters, fever, itching, and other symptoms.
The genetic predisposition for adverse reactions is much greater among people who have the HLA-B* 1502 human leukocyte antigen allele. This allele occurs almost exclusively in patients with Asian ancestry – a population that comprises around 5 percent of patients being considered for treatment with carbamazepine, the FDA said.
The FDA said the risk for adverse reactions to carbamazepine is between 1 and 6 per 10,000 new users in countries with mainly white populations, but it may be around ten times higher in Asian countries.
The FDA recommends a blood-based genetic test for the gene and notes that patients who test positive for the HLA-B* 1502 allele should not be treated with carbamazepine “unless the benefit clearly outweighs the increased risk of these serious skin reactions.”
Further information on the relabeling is available here.

The Scan

Pfizer-BioNTech Seek Full Vaccine Approval

According to the New York Times, Pfizer and BioNTech are seeking full US Food and Drug Administration approval for their SARS-CoV-2 vaccine.

Viral Integration Study Critiqued

Science writes that a paper reporting that SARS-CoV-2 can occasionally integrate into the host genome is drawing criticism.

Giraffe Species Debate

The Scientist reports that a new analysis aiming to end the discussion of how many giraffe species there are has only continued it.

Science Papers Examine Factors Shaping SARS-CoV-2 Spread, Give Insight Into Bacterial Evolution

In Science this week: genomic analysis points to role of human behavior in SARS-CoV-2 spread, and more.