FDA Releases First List of Drugs under Adverse Events Report System

The U.S. FDA, in its efforts to provide greater transparency to its drug surveillance and investigative measures, has provided a list of drugs under the Adverse Events Reporting System (AERS). The list contains 20 drugs and drug classes intended to alert patients to potential side effects of drugs. The regulator has emphasised that the drugs listed have a potential safety issue and the list should not be taken as advice to stop taking a medication. The FDA expects to trigger subsequent actions such as REMA (Risk Evaluation and Mitigation Strategy) and stronger drug labelling if the investigations support the potency of dangerous side effects.

Some of the entrants into the list, not publicly known so far, are Biogen Idec/Elan (U.S./Ireland)'s Tysabri (natalizumab) and Pfizer's Dilantin, the Wall Street Journal notes. Most of the product classes listed have already evoked some concern, such as the four drugs under tumour necrosis factor (TNF) blockers and Baxter Pharma's heparin. The list will now be unveiled quarterly although the information on the first quarter has arrived almost at the end of the third quarter of 2008. The source suggests that drug makers, although informed by the regulator before putting up the list, have expressed their concern over the decision indicating that there could be some confusion over whether the medication should be continued.

Outlook and Implications

The timing of the development could not be worse for the drug industry, compounding the U.S. regulator's recent publicly discussed actions on some drugs for dangerous side effects. However, the move is not altogether surprising either. The FDA's operations have come under scrutiny from the U.S. Congress, calling for greater transparency and accountability in tackling not only drug standards but also monitoring of adverse events associated with drugs. The AERS list is another step in ensuring the monitoring and enforcement of policies relating to drug safety for the FDA. However, the move could add confusion to the already existing system where the FDA publicly issues a notification on actions such as stricter drug labelling and/or REMS when studies and evaluation of data have led to strong support of higher side effects risks. The consequences of medical professionals refraining from prescribing a certain medication or consumers ceasing to take a medication due to its appearance on the list could be a real possibility despite the regulator's insistence that it is less likely. This could have an adverse short-term impact on the sales prospects of the product until the investigations are completed. The drug makers' criticism that the list does not provide any relevance or context may not be addressed by the regulator.

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