FDA: Screen genes before taking Tegretol

If you need more evidence that individualized drug therapy is the next frontier, look no further. The FDA has issued a new warning on carbamazepine, an epilepsy-slash-bipolar drug that can cause rare but severe side effects in certain patients of Asian descent. Before using the drug--marketed as Tegretol by Novartis and Equetro by Validus Pharmaceuticals--patients of Asian ancestry should undergo genetic testing, the agency said.

The black-box warning will alert patients to the potential for Stevens-Johnson syndrome and for toxic epidermal necrolysis, both severe skin reactions.

The FDA's genetic-testing recommendation is among its first. The agency previously has alerted healthcare providers to specific genetic variations and their effect on patients' response to particular drugs. A few months ago, the agency suggested that patients be tested for certain genetic variances before taking the blood thinner warfarin.

- here's the warning from the FDA
- read the report in The Wall Street Journal

Suggested Articles

It’s final: England won’t be covering AZ’s quick-selling Tagrisso in previously untreated non-small cell lung cancer patients with EGFR mutatations.

Top J&J meds have managed to hang onto market share in the face of new generics and biosims, but the drugmaker expects the pain to continue in 2020.

Lonza’s search for a new CEO is expected to be wrapped up this year as the CDMO homes in on a list of veterans from outside the company.