The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
Fake Alli Has Dangerous Dose
An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.
The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.
Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.
CVD Contraindication for Sibutramine
The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.
The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.
The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.
The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.
COPD Inhaler Deemed Safe
Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.
The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.
The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.
In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.