Fake drugs found from Canadian sites

From combined dispatches

Testing revealed fake versions of Lipitor, Celebrex and other widely used prescription drugs ordered through Web sites linked to a Canadian pharmacy, the Food and Drug Administration said yesterday.

Consumers who bought drugs through the 10 Web sites should not use the medications because they may not be safe, the FDA said. The sites include rxnorth.com, canadiandrugstore.com and rxbyfax.com.

Prescriptions ordered through the sites are filled by Mediplan Prescription Plus Pharmacy, also known as Mediplan Global Health, according to the FDA and information posted on the sites.

A message seeking comment left with the Minnedosa, Manitoba, company was not returned.

U.S. officials have intercepted and seized thousands of prescriptions filled by the pharmacy in recent months, said FDA Associate Commissioner Randall Lutter.

Subsequent testing has found counterfeit versions of the cholesterol drugs Pfizer Inc.’s Lipitor and AstraZeneca PLC’s Crestor, as well as Pfizer’s painkiller Celebrex, Novartis AG’s blood-pressure medication Diovan, baldness treatment Propecia and five other prescription drugs, the FDA said.

“Health Canada is aware of the issue. We are investigating, and if there are any safety concerns, we will be sure to alert the public,” said Paul Duchesne, a spokesman for Canada’s federal health department.

Some of the drugs contained the active ingredients found in genuine versions, but at lower concentrations. That could put patients at risk, Mr. Lutter said. The FDA testing is ongoing.

The Canadian mail-order drug business, led by Mediplan Global Health Inc., grew to more than $1 billion in annual shipments as Americans sought prices as much as 70 percent lower than in the United States. The FDA has long warned that medicines bought online may be counterfeit or dangerous. The United Nations’ World Health Organization estimated in February that counterfeit drugs account for 10 percent of the world market.

The annual market for counterfeit drugs will almost double to $75 billion by 2010, according to the Center for Medicine in the Public Interest, a New York drug-policy organization.

Consumers who ordered drugs through the Mediplan-linked Web sites should talk to their doctors and get their prescriptions refilled, Mr. Lutter said.

Canadian Internet pharmacies catering to American customers debuted roughly six years ago, after busloads of U.S. border-state seniors began venturing north in search of lower-priced prescription drugs.

Drugs ordered through the Mediplan-linked sites and intercepted by U.S. officials were not shipped from Canada, Mr. Lutter said. It was not clear where they were manufactured.

Importing drugs into the United States is illegal, though the FDA generally does not stop small shipments bought for personal use.

The FDA says it cannot guarantee the safety and efficacy of imported drugs.

In June, the FDA said it will enact a rule requiring all drug distributors that don’t buy directly from manufacturers to track the movement of pharmaceuticals as part of an effort to keep counterfeit medicines out of the United States.

Under the rules, shipments must be accompanied by paper or electronic documentation, known as “pedigrees,” tracing the drugs as they move through intermediaries to pharmacies and nursing homes.

The FDA said an operation last year at New York, Miami and Los Angeles airports showed that almost half of the imported drugs intercepted from four countries were to fill orders that consumers thought were coming from Canadian pharmacies.