Drug Safety Warning and Consumer Reaction

Drug Safety Warning and Consumer Reaction


Jim Mansfield, Customer Development, The Nielsen Company

Contributors: Melissa Davies, Jennifer Wehringer, Gabrielle Gibbs, Dale Norton, Robert Buckeldee, Meghan Palestis, Mike Hudak and Allison Fitzenreiter

SUMMARY: The U.S. Food & Drug Administration’s warning for the use of acetaminophen sent temporary shock waves across online chat rooms, which resulted in cautious consumers holding back purchases. While levels returned to normal about four weeks post announcement, online discussions continue to be significant. In the age of instant communications, marketers need to stay ahead of the curve with tactics that educate consumers quickly, accurately and proactively.

On June 30, 2009, the U.S. Food & Drug Administration (FDA) issued a recommendation and warning for the use of acetaminophen. Citing concerns of potential overdose and liver injury, the advisory committee recommended lowering the daily recommended dose of acetaminophen. The commonly used pain- and fever-reliever is found in several nonprescription cough and cold remedies as well as prescription products.

Pain business is big business…

Pain business is big business. Nielsen reports an estimated $732M was spent on total media for the pain category (excluding online) for the year ending June 2009, with more than half (56%) allocated to over-the-counter brands and the remainder to prescription products. With the widespread use of the drug and strong media attention, Nielsen analyzed consumer reaction to the announcement and the resulting impact on sales.

Rising concerns

Immediate consumer reaction to the news of the FDA advisory committee meeting drove a noticeable spike in both branded and generic online discussions of acetaminophen, as the chart below indicates. A review of online chatter for June and July shows buzz volume for acetaminophen. Branded discussion was also significant, with the most chatter among the brands that are most recognizable to contain acetaminophen.

Immediate reaction drove a noticeable spike in online discussions…

However, in the two-week time period following the advisory committee’s meeting, more than half (58%) of generic acetaminophen discussions was centered on risk information, while only one-fifth of branded product’s online chatter discussed health threats.


After three to four weeks following the announcement, consumer online buzz began to return to a level prior to the warning.

Interestingly, the online buzz and market impact generated was not combined with any broader overt advertising campaign. Nielsen reviewed commercials that aired for products within the pain category and did not find ads indicating specific safety messages in response to the FDA recommendation. However, Nielsen did find an increase in the mention of acetaminophen in advertisements in the weeks after the announcement.

A review of TV commercial spots of prominent pain reliever brands revealed that a few brands aired new creatives and modified prior advertisements with both a voice over and/or an “acetaminophen free” message. The changes seen in these advertisements took place the same week and continue through the most recent available period in September 2009.

Buyer beware

Immediately after the FDA warning was announced, sales of the entire pain category began to decline. Four weeks post announcement, Nielsen estimated that units declined approximately 0.5% (about 2.3 million units), but dollars increased 0.3%. The statistical model incorporated the promotion trends over the period, which was believed to cause the increase in dollars.

Sales of the entire pain category began to decline…

In the nine weeks following the announcement, sales resumed, with units and dollars up 1.3% and 0.8% respectively. It appears that consumers initially reacted and paused purchasing any pain product, but as they became more educated of the risks, purchases resumed (approximately five weeks after the warning). As a reference, the average consumers purchase cycle for pain remedies is approximately 50 days, which is within this analysis period.


To determine the predicted dollar and unit sales impact on the pain category, Nielsen employed a statistical method (multiple linear regression) to account for the multiple market levers that were occurring, which included promoted dollars, percent of promoted dollars, total promotion expenditures, online buzz, and gross rating points.

Some brands were more impacted than others…

The analysis showed that some brands were more impacted than others. Two directional themes emerged that manufacturers and retailers should consider as the acetaminophen recommendations evolve. First, the brands and store brand products with the most affiliation with acetaminophen were the most impacted by the warning. Second, some brands with dosage instructions that require the consumer to take fewer pills per day appeared to grow.

Feeling the pain

Were consumers who suffer from pain more “tuned-in” to the news surrounding the FDA recommendation? Nielsen analyzed the reach of broadcast and cable programming among ailment suffers who treat their conditions with either a combination of prescription and non-prescription remedies or just non-prescription remedies—in June prior to the acetaminophen announcement and post-announcement in July.

Seven ailment conditions that are treatable with medications that contain acetaminophen were analyzed: Allergies, Osteoarthritis, Rheumatoid Arthritis, Migraines, Chronic Tension headaches, Joint/Neck/Back pain, and Muscle Pain/Spasms.

Across ailment sufferers, reach was slightly higher…

Both broadcast and cable reached Adults 18–69 during this time period with a 96.75% reach in June and a 95.43% reach in July. However, across Adult (18–69) ailment sufferers whose conditions can be treated with acetaminophen, reach was slightly higher both before and after the announcement at the end of June. Perhaps the segment of sufferers with ailments that cause pain have an increased media reach due to the elevated awareness of the acetaminophen warnings.


Global implications

Global manufacturers and retailers of acetaminophen should take note as countries outside of the U.S. review the use and dosage recommendation of acetaminophen. As it turns out, there are unique differences with regards to how consumers in different countries ensure the appropriate use of non-prescription medications.

Half of all U.S. respondents read the pack…

A March 2009 Nielsen study revealed that close to half of all U.S. respondents (48%) said they ensure the proper use of non-prescription medications by reading the instructions on the pack. Only 15% said they refer to the product leaflet in the pack, and 12% consult with their pharmacist. These results compare starkly with consumers in Europe, for example, where (on average across 22 countries) fully one-third (32%) of consumers ensure responsible usage by referring to the product information leaflet in the pack, one-fourth (26%) through a dialogue with their pharmacist and only 16% from reading instructions on the pack.

These findings underscore the importance of understanding regional nuances when marketing in a global landscape. Strategies and tactics must reflect these differences to ensure optimal engagement with consumers and proper education on the benefits and safety of acetaminophen.

Cautious consumers

While the initial consumer reaction to the recommendation caused an increase of consumer generated media (online buzz) and decreases in the purchasing of over-the-counter pain products, these trends were later reversed. However, the consumer reaction to “back to normal” should be cautioned. Although consumers believe acetaminophen products are safe, they did show a strong reaction to a call for caution.

The consumer reaction to “back to normal” should be cautioned…

The Internet has enabled instant communication where word travels far, wide and deep. As made apparent with the acetaminophen warning, consumers readily seek out information—even without an overt advertising campaign to support it. Manufacturers and retailers have a responsibility—and an opportunity—to properly educate consumers and healthcare providers (pharmacists, physicians, etc.) via multiple media channels and product packaging that is most appropriate for the target audience.

Insights for manufacturers, retailers, and industry groups

The acetaminophen warning, albeit brief, affected the entire over-the-counter pain category. While consumers did return back to the category quickly, the same rebound may have not occurred as rapidly if the discussion of warnings and risks continued for an extended period of time.

In advance of future acetaminophen recommendations, Manufacturers, retailers and industry groups should consider the development of a consortium-like educational initiative about the safety of over-the-counter pain medications for consumers, pharmacists, physicians, and other healthcare providers. An educated healthcare system will be more engaged to repurchase the pain category vs. one that is less understood.