Major Tylenol recall; FDA concerned about BPA and children

Approvals, recalls, and other regulatory news.

Warnings, label changes, recalls

A recall of pediatric vaccines for H1N1 influenza because the vaccines contain lower antigen content than specified by the manufacturer, Sanofi Pasteur. Children who received the vaccine do not need to be revaccinated because the drop in antigen is unlikely to result in a clinically significant reduction in immune response.


A voluntary recall of McNeil over-the-counter medications because of the presence of an odor caused by a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events were temporary and non-serious. Recalled products include Tylenol (Extra Strength, Regular Strength, PM, 8 Hour, Arthritis Pain, Children's), St. Joseph Aspirin, Simply Sleep, Rolaids, Benadryl, Motrin IB and Children's Motrin.

A warning of a counterfeit and potentially harmful version of over-the-counter weight loss drug Alli being sold on the Internet. The counterfeit version contains the controlled substance sibutramine instead of orlistat, the active ingredient in the real drug. Patients who take the counterfeit pills according to the dosing directions for Alli could receive twice the recommended maximum dose of sibutramine. The dose can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure in healthy patients and elevated blood pressure, stroke, or heart attack in those with cardiovascular disease.

Notification of an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine hydrochloride (Meridia). A new contraindication will be added to the drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack, heart arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension.


A new high-dose vaccine (Fluzone High-Dose) against seasonal influenza subtypes A and B for patients 65 and older. The vaccine contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) in each dose and demonstrated an enhanced immune response compared with regular Fluzone, although non-serious adverse events were more frequent.

Tocilizumab (Actemra) for moderate to severe rheumatoid arthritis in adults who have not adequately responded to or cannot tolerate other drugs. The drug is limited to patients who have failed other therapies because of serious safety concerns including elevated liver enzymes, elevated LDL cholesterol, hypertension, and gastrointestinal perforations.


After reviewing data from large-scale ongoing cardiovascular trials, the FDA concluded that it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out. The agency is not advising health care professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks compared to other FDA-approved cholesterol-lowering medications.

Data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not show an increased risk of stroke, heart attack, or death in patients using the medicine. A March 2008 FDA Early Communication had described data suggesting a small increased risk of stroke associated with tiotropium, the medicine's active ingredient, but more recent research has resolved safety concerns, the agency said.

Based on recent studies, the FDA recently expressed some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. The agency is taking steps to reduce human exposure to BPA, including supporting industry efforts to stop production of baby products containing BPA and minimize the chemical's use in other products. The FDA has also called for a more robust regulatory framework for oversight and further public comment and external input on the science surrounding BPA.