NEJM Editorial Urges "Black-box" Warning For Tequin, And Suggests That This Antibiotic Should Be Recalled
On March 1, 2006 The New England Journal of Medicine released early an article about two Canadian studies concerning Tequin (gatifloxacin) which indicate that this antibiotic can have "life threatening" side effects including low blood sugar. At least one of the researchers who conducted the two Tequin studies is urging doctors to stop prescribing this antibiotic, which is made by Bristol-Myers Squibb Co.
The most alarming news in the NEJM March 2006 article about these two Canadian studies is that elderly patients who took Tequin were almost 17 times more likely to develop hyperglycemia (high blood sugar) than if they took another antibiotic. The researchers also reported that older patients were four times more likely to be hospitalized for hypoglycemia (low blood sugar). If untreated, both of these blood-sugar disorders can be fatal.
The significance of this news prompted The New England Journal of Medicine to make the Tequin article available online a month in advance of its scheduled March 30, 2006 publication date.
The NEJM posted online, also, an editorial about Tequin by Dr. Jerry Gurwitz, of the Meyers Primary Care Institute in Worcester, Massachusetts. Dr. Gurwitz said the FDA should consider mandating that a "black-box" warning be put on the Tequin label, or package insert. In the NEJM editorial, Dr. Gurwitz said further that when the increased risk of serious side effects from Tequin is compared to those of other drugs that have been pulled from the U.S. market in recent years, it seems that Tequin should be recalled, and that "this choice should not be a difficult one for physicians, patients, regulators and manufacturers." In support of his call that Tequin be pulled from the market, Dr. Gurwitz pointed out: "For every approved indication for [Tequin], there are safer, equally effective and less costly alternatives."
In mid-February, the FDA and Health Canada issued warnings for Tequin which said Bristol-Myers Squibb had told doctors that Tequin should not be used in diabetics, and that the elderly and those patients with kidney problems are more likely to have serious side effects from Tequin. The FDA and Health Canada also announced at that time there would be a labeling change for Tequin which would include stronger warnings about the blood-sugar problems linked to Tequin.
It is clear that Dr. David Juurlink, a researcher involved in the two Canadian studies and a physician at Sunnybrook and Women's College Health Sciences Center in Toronto, does not think stronger warnings on the Tequin label are the answer. Instead, he strongly urged doctors to no longer prescribe Tequin. In a March 2, 2006 Wall Street Journal article, Dr. Juurlink said: "There are multiple alternatives that are just as good and do not have this set of side effects that is unpredictable and potentially life threatening."
A March 1, 2006 article by Reuters quoted Dr. Juurlink stating that the blood-sugar problem "can happen to anybody" whether they have diabetes or not, and it "typically appears within a day or two of taking the drug." Therein, Dr. Juurlink remarked also that the actual risk of the drug is probably greater than the study revealed; "We can't identify everybody, only those who survived [a seizure from low blood sugar and made it] to the hospital or those sick enough to go to the hospital."
The Reuters article reported, also, that company spokesman Eric Miller said that Bristol-Myers Squibb has decided to stop actively marketing Tequin. Mr. Miller's comments surrounding that statement, however, were seemingly intended to make it appear that this decision to no longer "promote" Tequin had to do with economics, and not with the drug's safety profile. From the Reuters article:
Tequin was introduced onto the market in 1999 but only generated $150 million in sales for Bristol-Myers in 2005, a fraction of the group's $19.2 billion total revenue, said company spokesman Eric Miller. Tequin's sales totaled about $100 million in the United States.
This diversion tactic is not new for Bristol-Myers Squibb. As you may recall, in April 2004 the drug company voluntarily withdrew its antidepressant Serzone (nefazadone) from the U.S. market purportedly for economic reasons, and all the while denying that the Serzone recall had anything to do with the mounting reports of serious liver problems that had been associated with Serzone use.
(Posted by: Tom Lamb)