McNeil Consumer Healthcare addresses acetaminophen concerns on Tylenol.com
NEW BRUNSWICK, N.J. In the wake of the news around acetaminophen last week, McNeil Consumer Healthcare posted a public letter at www.tylenol.com to explain the news to Tylenol users.
“Recently, there have been reports about acetaminophen, the medicine in Tylenol, and the potential for liver damage if the medicine is misused or taken in overdose amounts,” the letter, signed by Edwin Kuffner, senior medical director, medical affairs at McNeil, opened. “As the makers of Tylenol, we share the FDA’s goal of helping to ensure that over-the-counter and prescription medicines are used safely and properly,” he said. “[But] Tylenol, when taken as directed, remains the safest pain reliever people can take.”
The letter goes on to explain that it’s inappropriate use of acetaminophen products, when patients consume more than the recommended dosage, that is linked to increased liver damage risk.
That message was replicated last week with full-page ads in USAToday, the New York Times and the Wall Street Journal, among other papers.
CRN criticizes CSPI’s allegations over increased health risks associated with selenium intake
WASHINGTON As part of its efforts to address misconception and misdirection around the safety and efficacy of dietary supplements, the Council for Responsible Nutrition on Tuesday issued a release criticizing the Center for Science in the Public Interest’s recent allegations that there are increased health risks associated with selenium intake.
“It is disappointing to read the kind of fear-mongering that is being attributed to the Center for Science in the Public Interest in connection with its campaign to clarify the permissible health claims that can be made for selenium and certain kinds of cancer,” stated Steve Mister, president and CEO, CRN. “Recently CSPI has been quoted as issuing statements like, ‘[selenium products] are dangerous to the health of men suffering from prostate cancer,’ ‘ may increase the risk of diabetes and hypertension,’ and that, ‘the [selenium] products pose a health risk to consumers because results from studies associate selenium intake with increased risk of developing diabetes and with increased risk of aggressive prostate cancer.’”
However, the authors of that study associating selenium with increased diabetes risk — the SELECT trial — “have themselves been very careful to state that any increased risk of diabetes that might have been associated with the SELECT trial was not statistically significant and may have been due to chance,” Mister said. “It is more than a little disingenuous to keep raising the specter of increased chance of diabetes from non-statistically significant data from a single study that may be due to chance.”
Likewise, CSPI has speculated about the dangers to men suffering from prostate cancer who supplement with selenium. CRN is not aware of any hard data that even remotely suggests that men with prostate cancer are turning to selenium as a cure or treatment, the association stated. Nor is there data that these men are forgoing their chemo-treatments or cancer drugs in favor of selenium.
The published study that CSPI cites in support of the allegations that selenium is associated with aggressive prostate cancer — Journal of Clinical Oncology, June 2009 — does not support that conclusion, Mister said.
“The real issue that is under scrutiny is whether the claim that selenium can reduce the risk of developing prostate cancer is adequately supported by the evidence,” Mister added. “CRN and CSPI can certainly disagree about that and whether particular claims appropriately communicate to consumers their risk of developing cancer; it would be entirely appropriate for CSPI to urge FDA to deny the claim while CRN argues that the data is sufficient to support such a claim. But it’s quite disturbing to see CSPI resorting to this kind of hyperbole to attract headlines and divert attention from the real issues.”
NACDS announces support of new methamphetamine legislation
WASHINGTON A law that would expand the Combat Methamphetamine Epidemic Act of 2005 was introduced last month by Rep. Bart Gordon, D-Tenn. The bill would require distributors of pseudoephedrine products to sell only to self-certified retailers registered with the Drug Enforcement Agency.
It also would require the DEA to create an online database where distributors could check if retailers have certified that staff has been properly trained. The bill also would clarify that a retailer who negligently fails to file self-certifications, as required, can face civil fines.
The National Association of Chain Drug Stores expressed its support of the legislation. “These provisions will help prevent the diversion of pseudoephedrine … products for illegitimate purposes, while still allowing consumers with legitimate needs to access these necessary medications,” stated NACDS president and CEO Steve Anderson in a recent letter to Gordon.
“Even with the 2006 law, our country still has a huge meth problem,” stated Gordon in introducing the legislation, called the Combat Methamphetamine Enhancement Act of 2009. “In Tennessee alone, which leads the Southeast in the number of meth labs, 1,300 labs are expected to be seized by the year’s end. We need to do what we can to further reduce access to meth ingredients — this bill will do just that.”
Rep. Jim Sensenbrenner, R-Wis., is co-sponsor of the bipartisan legislation. “Over the years, the Drug Enforcement Agency has had trouble identifying noncompliant stores — with the number of stores estimated to be in the tens of thousands,” Sensenbrenner said. “This legislation will make it tougher for individuals to make meth, and therefore make it even more difficult to buy meth.”
According to the DEA Web site, 53,989 retailers had self-certified and registered their operations by Oct. 27, 2008, including 27,678 pharmacies and drug stores. The self-certification program includes a documented training program for all employees engaged in the sale of PSE products.
The Combat Methamphetamine Enhancement Act already has passed the Senate with bipartisan support after being introduced by Sen. Dianne Feinstein, D-Calif., in January. The legislation presently is before the House Committee on Energy and Commerce.