Drug Watch — The FDA’s New Drug Safety Web Site

Belatedly, yielding to criticism from Public Citizen and many others that it is not doing enough to protect the public’s safety, the Food and Drug Administration (FDA) announced on May 5, 2005  that it intends to develop and disseminate important emerging drug safety information to healthcare professionals and the public. This information will appear on an FDA Web page to be called “Drug Watch.”  

Until the Drug Watch Web site is fully operational, the FDA has created an interim Web page that contains safety information on 213 drugs. The interim page is on the agency’s Web site. A list of drugs currently on the page provides links to additional information.

Unfortunately, this still leaves people without access to the Internet in the dark.

Even when fully operational, the site will not be very critical or have very many, if any, of the details about the listed drugs merited by the evidence of their dangers. For this, you will still need to consult the book Worst Pills, Best Pills or www.worstpills.org.

The Drug Watch Web site is mainly intended to identify the list of drugs that the FDA is actively evaluating for potential early safety problems. The agency maintains that the Web site is not intended to be a list of drugs that are particularly risky or dangerous. Rather, inclusion on Web site signifies that the FDA is attempting to assess the meaning and potential consequences of emerging drug safety information on the drugs.  

This sounds like bureaucratic “double speak” that is an attempt to deflect drug manufacturers’ displeasure with having one or more of their drugs included on the Web site because it could affect a drug’s marketing potential.

The FDA defines an emerging risk, or emerging safety concern, as a possible serious new adverse effect potentially related to a drug on the market that has been reported to the FDA and that the agency is analyzing.  

An adverse effect is considered new when, for example, the effect was not seen, or the rate or severity of the effect was not seen, during clinical testing, but was identified after the drug was available on the market and widely prescribed. Sometimes drugs are prescribed for uses that are not approved by the FDA, called off-label uses, with unanticipated adverse reactions that can cause serious injury and in some cases needless deaths. In addition, if the FDA receives information that a drug interacts with another drug, and this interaction may be causing a serious adverse effect, this information would be considered emerging. This is the kind of information that would be posted on the Drug Watch Web page according to the FDA.

The FDA has identified several factors that it plans to consider when deciding which drug products and information to include on the Drug Watch Web site:

• Whether new and emerging safety information could significantly affect prescribing decisions or how patients should be monitored. For example, a drug that has been identified with a possible association with kidney failure should not be prescribed to patients with kidney disease. This may also include newly identified possible drug-drug interactions. Such interactions need to be considered in prescribing.
• Whether measures can be taken as a result of providing information that could help to prevent or mitigate harm. These could include, for example, limiting prescribing to patients most likely to benefit from the drug, conducting special monitoring of patients on the drug, or staying alert for signs of serious adverse reactions.
• Whether an unapproved, off-label, use of the drug appears to pose the possibility of significant harm to patients.

The FDA says it plans to regularly update the information on the Drug Watch Web site as new information becomes available. As safety issues are resolved, the FDA intends to promptly remove drugs from the Drug Watch. For example, a drug may be removed from the Drug Watch site when its professional product labeling has been revised to address the safety concerns; when FDA has taken other steps to adequately communicate information to healthcare professionals and patients; or when FDA has determined that, despite the initial signals, there is no new safety concern.

What You Can Do

In addition to subscribing to Worst Pills, Best Pills News or www.worstpills.org, you should consult the FDA’s new drug safety Web site for drug information or before you have any new prescriptions filled.