Research debunks Tamiflu-suicide link in children
A new study published by researchers from the University of Illinois at Chicago suggests that the drug oseltamivir – commonly known as Tamiflu – does not cause an increased risk of suicide in pediatric patients.
The U.S. Food and Drug Administration originally approved the drug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self-harm and even suicide.
However, clinical studies examining the association between the use of Tamiflu and neuropsychiatric side effects in children, including suicide, have so far been inconclusive and limited by methodology and potential confounding factors.
“When the FDA puts a warning out about a drug, doctors and the public take notice,” corresponding author James Antoon, assistant professor of clinical pediatrics in the UIC College of Medicine, said. “While the warnings are necessary, they are often not based on conclusive clinical data, which can make it difficult for physicians to truly know the potential side effects of a drug as they evaluate its possible benefits for individual patients.”
To fill this gap, Antoon and his colleagues in the UIC College of Pharmacy retrospectively studied the association between the use of Tamiflu – the only commercially available medication approved by the FDA to treat the flu – and the most consequential of those reported side effects: suicide.
“The potential link between a drug and suicide is a particularly difficult topic to study,” Antoon said. “Many events, which can happen simultaneously or over time, can influence a person to attempt suicide, as can an illness itself – so it can be difficult to study scientifically. That’s why we used a novel method called a case-crossover design. This analysis is different because it allowed us to use each individual subject as his or her own comparison – we retrospectively studied how patients behaved when on Tamiflu and compared it to their behavior when they were not taking the drug.”
The researchers identified 21,047 children between the ages of 1 and 18 who attempted suicide during five recent flu seasons (2009-2013) from a national administrative claims database. Of this group, 251 of those children were exposed to Tamiflu, which was determined based on outpatient pharmacy dispensing data. The mean age of this group was 15 years, 61% were female, and 65% had an underlying mental health diagnosis.
“For each of the 251 patients, we assigned the 10-day period immediately before the suicide attempt as the case period and we identified up to four earlier control periods of the same length, in the same flu season,” Antoon said. “This helped us to account for within-person confounders, like depression, mental health, trauma and abuse, and other factors, like race or ethnicity.”
The researchers repeated the analysis with flu diagnosis alone, without the use of Tamiflu, to see if the infection itself could have been a confounding factor associated with suicide risk.
“We did not find any association between exposure to Tamiflu and suicide in pediatric patients,” Antoon said.
While Antoon believes the findings, which are published in the Annals of Family Medicine, will help to alleviate some fears health care providers may have about prescribing the medication in healthy children, he says doctors will likely continue to prescribe Tamiflu with caution.
“I think physicians will welcome a large, rigorous study on this topic and factor this information into their decision-making process,” he said. “While this study addresses suicide, there are still many other questions about other possible neuropsychiatric side effects of the drug, which we plan to study in the future. There are also other reasons to use caution when prescribing the drug, including resistance and efficacy in children.”
CHPA Educational Foundation names new chairman
The CHPA Educational Foundation board of directors on Wednesday elected Stephen Neumann as its new chairman. Neumann is a long-time foundation board member and serves as vice president, consumer insights and business intelligence for Bayer Consumer Health.
Neumann succeeds Christopher DeWolf, president and CEO, Lil’ Drug Store Products, who was the foundation’s chair for the past two years.
“I want to thank Chris for standing at the helm of the foundation, leading us through a time of great change. We are delighted he will be staying on the board,” Anita Brikman, executive director of the CHPA Educational Foundation, said. “I am thrilled for Steve to take on his new role as chair. We look forward to his leadership in helping the foundation to grow and advance its strategic priorities.”
“I am excited to take on this new leadership role with the foundation,” Neumann said. “Our board is filled with knowledgeable and dynamic consumer healthcare leaders, and I look forward to working with them to help advance the foundation’s vision of helping consumers lead healthier, happier lives through responsible self-care.”
At the foundation board meeting during CHPA’s Annual Executive Conference, held March 11-14, 2018, at Turnberry Isle Miami, Fla., the foundation also elected two new board members, including Amardeep Kahlon, chief marketing officer, commercial North America, GSK Consumer Healthcare, and Kyle Stenzel, senior vice president, sales, North America, Combe.
In addition to Neumann, Kahlon and Stenzel, other members of the CHPA Educational Foundation board of directors include DeWolf; Morris Lewis, senior director, corporate affairs lead, Pfizer Consumer Health; Scott Melville, president and CEO, Consumer Healthcare Products Association; Ryan Olohan, managing director, healthcare, Google; Joy-Lee Pasqualoni, consumer communication leader – North America, Johnson & Johnson Consumer; and David Tomasi, commercial director, North America personal health care, Procter & Gamble.
The CHPA Educational Foundation’s mission is to be the trusted source of information on the responsible use of consumer healthcare products including over-the-counter medicines and dietary supplements.
Flu now seeing gains in the Pacific Northwest, Walgreens reports
The Pacific Northwest is now realizing significant flu activity gains according to latest Walgreens Flu Index released Wednesday.
The Seattle and Tacoma, Wash. markets led the nation in flu activity gains for the week ended March 10, according to the report, with Portland, Ore., ranking No. 3. Similarly, the greatest amount of flu activity tracked currently across the Pacific Northwest was found in the Lincoln and Hastings markets in Nebraska while Omaha, Neb., ranked No. 3.
The top 10 designated market areas as measured by flu activity gains for the week ended March 10 were:
- Seattle-Tacoma, Wash.;
- Reno, Nev.;
- Portland, Ore.;
- San Diego;
- Albany-Schenectady-Troy, N.Y.;
- Monterey-Salinas, Calif.;
- Sacramento-Stockton-Modesto, Calif.;
- San Francisco-Oakland-San Jose, Calif.;
- Lansing, Mich.; and
- Toledo, Ohio.
The top 10 designated market areas as measured by flu activity for the week ended March 10 were:
- Lincoln & Hastings-Kearney, Neb.;
- Harlingen-Weslaco-Brownsville-McAllen, Texas;
- Omaha, Neb.;
- El Paso, Texas (Las Cruces, N.M.);
- Columbia-Jefferson City, Mo.;
- Oklahoma City;
- Des Moines-Ames, Iowa;
- Corpus Christi, Texas;
- Davenport, Iowa-Rock Island-Moline, Ill.; and
- La Crosse-Eau Claire, Wis.
The Walgreens Flu Index is a weekly report developed to provide state- and market-specific information regarding flu activity, and ranks those states and markets experiencing the highest incidences of influenza across the country. The Flu Index provides insight by showing which cities or metropolitan areas are experiencing the most incidences of influenza each week based on Index methodology. The data does not measure actual levels or severity of flu activity.
The Walgreens Flu Index is compiled using weekly retail prescription data for antiviral medications used to treat influenza across Walgreens and Duane Reade locations nationwide, including Walgreens locations in Puerto Rico. The data is analyzed at state and geographic market levels to measure absolute impact and incremental change of antiviral medications on a per store average basis, and does not include markets in which Walgreens has fewer than 10 retail locations.