Tylenol recalls underscore larger drug issues

If bottles of adult or child-strength Tylenol, Benadryl or Motrin linger in your medicine cabinet, now is a good time to see if they're among the drugs recalled in the last 12 months. (See product list here.) If they are, dispose of them properly. These medications may have been tainted by a wood preservative-- which could cause nausea, vomiting, and diarrhea--or the products may have other manufacturing defects.

In what is likely the largest related series of drug recalls in U.S. history, according to recent analysis by QuarterWatch, a drug safety report from the nonprofit Institute for Safe Medication Practices, millions of bottles of these over-the-counter medications have been yanked from pharmacy shelves since September 2009 by Johnson & Johnson's McNeil Consumer Products subsidiary. But useful consumer information may go unreported.

Here's a closer look at the information we don't know, plus what you can do to protect yourself.

When a recall occurs, just how many bottles, tablets or number of people affected may remain a mystery to the public. The manufacturer typically announces the number of "lots" of a recalled drug (as well as the actual lot numbers, which help identify if you have a recalled drug or not) - but that's a manufacturing term, which can be any size.  With some Tylenol and related products—one recent recall notice cited "21 lots," but reported estimates ran into millions of bottles.

The FDA can not force a company to disclose to the public more specific detail about the sheer volume of drugs affected or even how many people may have received a recalled drug. Manufacturers under the umbrellas of the Consumer Product Safety Commission (CPSC) and National Highway Transportation and Safety Administration (NHTSA) will usually publically report how many cars, cribs or other items are affected. Both of these agencies have the ability to mandate a recall.

Unfortunately, with medication, oftentimes only the "lot" numbers for products that are recalled are in the press release. Consumers can usually check the lot number on an OTC product against a list of lot numbers to see if theirs matches. But the manufacturer is not required to disclose to the public which retail stores sold them, although announcements frequently confirm the states and countries.

The recent expanded Tylenol recall in July, due again to possible tainting by a wood preservative chemical—announced that products had been sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica, but no information that we could find was released to the public as to where these products may have been purchased. When recalling certain products, manufacturers under the CPSC usually announce where products were sold and during what time period, and is required if the recall is mandatory.

And, how would you know if a drug is recalled? When it happens, prescription drugs may be easier to track, since most large chain pharmacies (and likely all pharmacies do, to some extent) and membership stores like Costco can communicate directly with each customer. But in the case of drugs sold over-the-counter (without a prescription), such as Tylenol, the situation is murkier.

Usually, consumers can rely on media reports of large-scale recalls announced by the FDA (such as those found here at CRBestBuyDrugs.org as well as ConsumerSafety.org). Without that, you'd have to dig through the FDA or manufacturer websites for more detailed information. Or ask your pharmacist.

Also, drug manufacturers usually release their own recall announcements. The FDA then reposts that release in order to better alert the public. However, we found a potential timing issue. In a recent recall of free samples of a prescription drug, Coumadin (warfarin) a common drug used to prevent blood clots the drug manufacturer seems to have initiated a recall well before the company's news release was posted. The manufacturer sent a letter to health care practitioners dated June 25th, but the public release was dated July 12th. The FDA reposted this release on July 12th, and two days later, posted their own safety alert.

Always inspect the medication you receive, and if pills or capsules are of different sizes, have an unusual odor, are stuck together, or are shaped oddly, don't take them and return them to your pharmacy.

Remain vigilant. If you regularly take any medication—OTC or prescription—and you do hear about a recall, check to see if you are taking the drug in question. You can visit CRBestBuyDrugs.org, as well as the FDA's website at www.fda.gov for periodic drug recall announcements. Or ask your pharmacist.

Consider using a single pharmacy for all prescription and non-prescription medications—and alert your pharmacy when you purchase an OTC drug according to Carmen Catizone, RPH, executive director/secretary of the National Association of Boards of Pharmacy. That way, the pharmacy can record it in your medication record, ensure that you don't experience interactions between these and any prescription medications you may be taking, and can make it easier to alert you directly if a recall—especially if it's an OTC drug—has occurred.

Support stronger rules. In mid-July, Congressman Edolphus Towns (D-N.Y.) introduced a bill that would give FDA mandatory recall authority for drugs and require manufacturers to notify the FDA when they have reason to believe drugs in interstate commerce are misbranded or adulterated and could cause serious harm or death.

Sign up for automatic e-mail notification from all government safety agencies by going to www.recalls.gov.