Ever since the FDA and Congress started asking Johnson & Johnson to explain why it keeps recalling medicine, there have been references to an unpublicized “recall” that happened in November 2008. Last month, at a hearing of the House Oversight and Government Reform Committee, a J&J executive swore that the company didn’t mean to mislead anyone. It turns out that wasn’t exactly accurate: Bloomberg has obtained emails from J&J’s company, McNeil Consumer Healthcare, that show executives knew the secret recall would trigger an FDA reaction if the agency got wind of its full scope.
Remember the recalled liquid Tylenol and other children’s medicines last month? Or the stinky drugs that were recalled back in January? Or the children’s Tylenol that was recalled last September? The FDA remembers, which is probably why it’s “conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company.” Also, a date has now been set (May 27) for the House Committee hearing where the CEO and chairman of parent company Johnson & Johnson are expected to testify.
One of the implied promises of a brand name, especially when it comes to drugs, is you can expect higher quality, but maybe that doesn’t apply when it comes to McNeil products.The FDA says the plant that produced the recently recalled children’s Tylenol, Motrin, Zyrtec and Benadryl, was using raw materials that were contaminated with bacteria. The plant also lacked adequate quality-control procedures and was dirty. So far none of the recalled medicine has tested positive for bacterial contamination, but the FDA report suggests that the contaminated material was used to make the recalled lots. The plant has been shut down indefinitely.
When J&J’s McNeil Consumer Healthcare Unit announced a recall of children’s Tylenol, Motrin, Zyrtec and Benadryl over the weekend, it also provided a toll free number you could call for more info. Ron Lieber at the New York Times called it on Saturday to find out how the refund process would work. What he got was a three minute recording telling him to throw the products in the trash, but nothing else.
If you’re picking up your prescriptions close to closing time at Target’s pharmacy, you might want to make sure you don’t have any questions after closing time. Reader Kathy says she realized that she had a question about her son’s prescription immediately after picking up the prescription, but when she turned around to ask it — she was too late.
As part of their inquiry, FTC staff made undercover purchases from the sites. No one asked the clandestine buyers to provide verification of a prescription and the shipped drugs did not include doctors’ instructions or dosage information, officials said.
Pediatricians are asking the FDA to recall all OTC cough medicines for children under six years old, and the FDA is holding a public hearing on the subject today. One reason this has only recently become an issue is that when the FDA originally set rules for OTC cough medicines, they were based only on studies for adults, not kids, writes the Associated Press. Although there’s a low risk of unintentional overdose—the AP says about 7,000 children are admitted to ERs each year—the other issue is that there’s very little evidence that they’re effective.
We’re sorry, but there is no cure for cancer. The FTC is going after eleven companies that claim otherwise by selling potions, herbs, and a “systematized program of thinking good thoughts” masquerading as cures. You shouldn’t need a federal agency to tell you that the “Miracle Water for Cancer” doesn’t actually cure anything, nor does it reverse weight gain and aging. Bummer. Six of the snake oil companies agreed to settle, but five will crawl before a judge and argue that they can cure cancer. Let’s look at the list…
We’re big fans of Target’s smart approach to package design for medicine. They may want to give a little more thought to their OTC generics, however—how about using more distinct labeling for the children’s line, for example? One reader explains why this would be a lot safer.
Bad news from the FDA: people who treat their foot and leg ulcers with the cream Regranex are five-times more likely to die from cancer.
Johnson & Johnson today recalled several infant cough and cold medicines, citing “rare instances of misuse leading to overdose, particularly in infants under two years of age.”