FDA Reprimands Drug Companies for Misrepresenting Drugs’ Safety

By April 22, 2010Dangerous Drugs

According to pharmaceutical industry journal PharmaLive, the U.S. Food and Drug Administration has rebuked GlaxoSmithKline for false advertising about its chronic lymphocytic leukemia (CLL) drug Arzerra (ofatumumab). In a letter to the company, the FDA says that an advertisement for Arzerra in the Journal of Clinical Oncology fails to mention any of the risks associated with the drug or the limitations on the drug’s use. Because of these omissions, the FDA says that the ad implies that Arzerra is safer and more effective than evidence says it is. As a dangerous drugs attorney, I took note of this article because numerous drug companies have been discovered making similar intentional violations, exposing millions of patients to serious risks.
The FDA also upbraided GlaxoSmithKline for failing to submit its Journal of Clinical Oncology ad for the FDA’s review before publication. Because Arzerra was within 120 days of being approved by the FDA for marketing, its promotional materials were supposed to be vetted by the FDA. GlaxoSmithKline had framed the advertisement as a “disease awareness” ad, which purports to inform people about a disease without mentioning a particular drug, so no disclosure of drug side effects would have been required. But the FDA said that the ad’s allusions to Arzerra were transparent, and that the ad should have described the adverse reactions to Arzerra that patients could suffer. For example, Arzerra can increase the risk of an often fatal viral infection of the brain, progressive multifocal leukoencephalopathy, which resembles a speeded-up version of multiple sclerosis. Arzerra can also be harmful to patients who have a history of hepatitis.
Drug manufacturers have a legal responsibility to warn doctors and patients of the risks associated with their drugs. As a defective prescription drug attorney, I am glad that the FDA is taking GlaxoSmithKline to task for trying to sidestep its responsibility to inform the public of all relevant safety information about Arzerra. A number of drug manufacturers have been held liable in lawsuits over false advertising of their drugs’ effectiveness and safety. Patients with serious illnesses like CLL have enough to worry about without also having to research faulty claims about their medications, or worry about undisclosed safety information. Unfortunately, as the FDA’s letter to GlaxoSmithKline shows, drug manufacturers often place their own financial interests ahead of patients’ safety.


The drug defect lawyers at the Lowe Law Firm specialize in helping patients who have been harmed by medications that were supposed to help them. If you have been harmed by a prescription or over-the-counter medication, please call the Lowe Law Firm for a free consultation with one of our experts. We will advise you about recovering compensation for medical expenses, lost wages, permanent injuries and pain and suffering from the company that caused your injury. Please call us toll-free at 1-877-678-3400 or contact us through our Web site.