Here is some good news.
Pfizer Inc. said it finalized a $2.3 billion settlement over marketing the drug Bextra for unapproved uses. Under the settlement, Pfizer unit Pharmacia & Upjohn will plead guilty to one criminal count of violating the Food, Drug, and Cosmetic Act with regards to drug marketing. The settlement also covers civil charges over the drug’s marketing.
What is Bextra?
Bextra is a type of pain medication, called COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis and menstrual pain.
Why did the government act?
Despite earlier warnings in the Bextra label, the FDA is still receiving reports of serious, potentially fatal, skin reactions such as SJS and TEN. Patients known to have an allergy to sulfa products should not take Bextra.
Other COX-2 selective NSAIDs and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but these serious side effects appear to occur more often for patients taking Bextra than for other COX-2 agents.
In addition, results from a new study of more than 1500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug. These problems include heart attack, stroke, deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).
Bextra is a “Me Too Drug” What is that?
Me-too drug: A drug that is structurally very similar to already known drugs, with only minor differences. The term “me-too” carries a negative connotation.
The take home message here is that Pfizer brought an unsafe drug to market and then promoted that unsafe drug for unapproved uses in a effort to reward the company’s shareholders. Fortunately, in this case, the Federal government stood up for the interests of the people actually taking the drug.
A 2.3 billion dollar fine— that’ll raise a welt.