FDA launches investigation into ARBs after potential cancer risks found
After a meta-analysis published in last month’s Lancet Oncology showed that angiotensin-receptor blockers (ARBs) could increase rates of new cancers by 8 to 11 percent, the FDA in response has launched an investigation to review the drug class widely administered to treat high blood pressure and heart failure.
While the FDA said it still believes the benefits of ARBs—reductions in stroke, MI and HF—outweigh the risks, the agency said the review is ongoing and no conclusions have been made as to whether or not they have potential to increase new cancers.
The FDA has recommended that patients continue taking the drugs and said that once the agency has the results of the review they will be made public.
The ARB market consists of seven FDA-approved drugs: olmesartan, telmisartan, losartan, candesartan, valsartan, irbesartan and eprosartan.
However, the Lancet's meta-analysis of over 60,000 patients focused solely on telmisartan (Micardis; Boehringer Ingelheim), losartan (Cozaar; Merck) and candesartan (Atacand; AstraZeneca).
William B. White, MD, president-elect of the American Society of Hypertension, estimated that telmisartan can reduce the incidence of MI and stroke by 25 to 27 percent and 35 to 40 percent, respectively. But, lead author of the meta-analysis Ilke Supahi, MD, of the University Hospitals Case Medical Center in Cleveland, told Cardiovascular Business News that ARBs may not be much more superior than existing blood pressure pills. "Even dummy pills can do as well as ARBs in certain patients," he said.
The FDA has urged physicians to report any adverse events involving ARBs to its MedWatch program.
While the FDA said it still believes the benefits of ARBs—reductions in stroke, MI and HF—outweigh the risks, the agency said the review is ongoing and no conclusions have been made as to whether or not they have potential to increase new cancers.
The FDA has recommended that patients continue taking the drugs and said that once the agency has the results of the review they will be made public.
The ARB market consists of seven FDA-approved drugs: olmesartan, telmisartan, losartan, candesartan, valsartan, irbesartan and eprosartan.
However, the Lancet's meta-analysis of over 60,000 patients focused solely on telmisartan (Micardis; Boehringer Ingelheim), losartan (Cozaar; Merck) and candesartan (Atacand; AstraZeneca).
William B. White, MD, president-elect of the American Society of Hypertension, estimated that telmisartan can reduce the incidence of MI and stroke by 25 to 27 percent and 35 to 40 percent, respectively. But, lead author of the meta-analysis Ilke Supahi, MD, of the University Hospitals Case Medical Center in Cleveland, told Cardiovascular Business News that ARBs may not be much more superior than existing blood pressure pills. "Even dummy pills can do as well as ARBs in certain patients," he said.
The FDA has urged physicians to report any adverse events involving ARBs to its MedWatch program.