The FDA has launched a website that provides summary information about ongoing and completed post-marketing safety evaluations of adverse drug experience reports made to the agency for new drug applications and biologic license applications (BLAs) approved since Sept. 27, 2007.
The evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number or potential new safety concerns now that the products are being used in the general population, according to the agency. In accordance with federal regulations, these post-marketing evaluations are performed 18 months after approval of the drug or after its use by 10,000 individuals, whichever is later.
The FDA is posting this information to “improve the transparency of information about drugs and to provide patients and healthcare providers better access to information about drugs by developing a website with specified types of drug safety information.”
Some examples of drugs listed on the website that are relevant to the cardiovascular community are:
- Nebivolol hydrochloride (Bystolic, Forest Laboratories), which treats hypertension;
- Simvastatin/niacin (Simcor, Solvay Pharmaceuticals and Abbott), which is used to decrease various types of cholesterol and triglycerides, and to increase HDL cholesterol among certain patient populations; and
- Aliskiren hemifumarate/hydrochlorothiazide (Tekturna HCT, Novartis), which also is used to treat hypertension.