The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs. On one hand, this shows that FDA and manufacturer safety surveillance programs have identified these significant safety risks. On the other, it illustrates that placing warnings in product information only begins the process of managing drug safety risks. Relative rates vs. report expectations are detailed.
These data come from QuarterWatch™ an Institute for Safe Medication Practices surveillance program that monitors all serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration through MedWatch, its adverse event reporting system. The goal is to identify signals that may represent important new drug safety issues.
Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability. Examination of more than 5600 drug labels yielded over half a million side effects. An average drug label and the more commonly prescribed drugs averaged 70 and 100 side effects, respectively. The upper range in a single label was 525 reactions. Information overload can overwhelm physicians, who must weigh the risks and benefits when prescribing a medication. The Food and Drug Administration discourages such ‘over warning,’ but information overload is presently the rule rather than the exception. Not surprisingly, medications typically used by psychiatrists and neurologists had the most complex labels, while drugs used by dermatologists and ophthalmologists had the least. Although providing drug safety information more efficiently to both health care providers and the public is warranted, drug manufacturer liability concerns must also be addressed.
Source: Drug Discovery and Development
Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the risk of serious health problems arising from off-label uses of the drug. Douglas S. Ingram, the executive vice president of Allergan, asserts that by allowing off-label drug use but by “prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks, benefits, and techniques for off-label uses, does not serve the public health or patient care.” Jeffrey N. Gibbs, a Washington lawyer specializing in food and drug law, asserts this case to be “the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company. It’s a precedent-setting case.” Although other pharmaceutical companies have not joined the lawsuit, the outcome will be closely monitored. An article in the HealthLawProf blog attempts to place this issue into historical context. It is speculated that Allergan may be utilizing the case to gain leverage with the Agency in negotiating the legal distribution of information on the prevalent off-label uses of drugs, like Botox. New York Times, 2 October 2009.
What are your thoughts on how best can the pharmaceutical industry distribute safety information on the off-label use of its drugs?
Posted by cdavenport on Wednesday Oct 7, 2009 Under News Releases
Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483 (Inspectional Observations). Upon completion of a facility inspection, the FDA may issue a form 483 to notify an inspected establishment’s top management of objectionable conditions. These conditions may relate to products, processes, or other violations of the Federal Food, Drug, and Cosmetic Act (and related acts) that were observed during the inspection. In the past, late and/or multiple responses to a FDA form 483 have delayed the issuance of warning letters while these responses were reviewed and addressed. Under the current paradigm, however, ongoing or promised corrective actions may not preclude the issuance of a warning letter by the Agency. The program’s goal is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. The program will be assessed by the FDA after approximately 18 months.
Sources: PharmTechTalk and Federal Register.