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Celebrex-treated patients show higher odds than do other patients of experiencing MI, according to analysis of six trials A new systematic review and meta-analysis indicates that Pfizer Inc.'s Celebrex (celecoxib) may increase the risk of myocardial infarction to a similar extent as do other members of the COX-2 specific inhibitor drug class.

Researchers in New Zealand culled data from bibliographic databases, Food and Drug Administration files and pharmaceutical company Web sites. All six trials included in the analysis were randomized, placebo-controlled, double-blind trials that studied Celebrex for at least six weeks and presented data on serious cardiovascular thromboembolic events.

The primary study analysis compared Celebrex with placebo among 4,422 patients involved in four of the placebo-controlled trials.

Three of the studies reported that 29 MIs occurred in 2,574 of the Celebrex-treated patients, while only six occurred in the 1,447 placebo-treated subjects. Thus, the odds that patients treated with Celebrex experienced MI was 2.26 times the odds in the placebo group.

However, the odds of experiencing cerebrovascular events, cardiovascular death or composite cardiovascular events were not significantly higher in the Celebrex arms of the four trials.

Results were similar in the secondary meta-analysis, which compared Celebrex with placebo, diclofenac, ibuprofen and paracetamol in all six trials of 12,780 patients.

The odds of MI with Celebrex were 1.88 times higher than were the odds with any of the comparator drugs. Celebrex was not associated with a significant increase in any of the other outcome measures.

The investigators noted, however, that the six studies were neither powered nor specifically designed to determine Celebrex-associated risk of cardiovascular thromboembolic events.

Still, they concluded, "This finding would suggest that the preferential risk/benefit assessment afforded [Celebrex] over other COX-2 inhibitors by the FDA may not be supported by the currently available evidence."

This study was published in the March issue of the Journal of the Royal Society of Medicine.

According to Professor Richard Beasley, who spoke to Dow Jones Newswires, "These findings are critical, as the risk is similar in magnitude to the 2.24-fold increased risk of heart attack with [Merck & Co. Inc.'s] Vioxx [(rofecoxib)]."

Mark Crotty, general manager at Pfizer New Zealand Ltd., told Dow Jones the results were "extremely misleading" because the study is "very much an incomplete review of the data--selecting six studies out of 48 available."

He went on to say, "We very much dispute and are concerned with the nature of these findings. It's concerning for people who have been through a lot of uncertainty on the use of this medication ... ."

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Avastin may be linked to cases of leukoencephalopathy syndrome Roche will brief the Food and Drug Administration regarding rare cases of a brain condition seen in some patients taking Avastin (bevacizumab), a blockbuster cancer drug the company developed with Genentech Inc., Reuters reported.

The New England Journal of Medicine released correspondence received from physicians at Stanford University Medical Center and the Medical College of Wisconsin speculating that Avastin was directly associated with the development of reversible posterior leukoencephalopathy syndrome (RPLS) in two women taking the drug. RPLS can result in blindness.

In the first case, a woman aged 59 years who received seven injections of Avastin for the treatment of metastatic renal cancer presented to the emergency department with severe lethargy and was subsequently admitted after experiencing a tonic-clonic seizure. The physicians noted that the patient's blood pressure fluctuated and that a neurological examination of the patient revealed cortical blindness and extensor plantar responses. Magnetic resonance imaging showed extensive leukoencephalopathy in the subcortical (distal vasculature) distribution. The patient made a rapid recovery, and the follow-up MRI six weeks later showed complete resolution of the leukoencephalopathy.

In the second case, a woman aged 52 years who received three cycles of chemotherapy with fluorouracil, leucovorin calcium and Sanofi-Aventis Group's Eloxatin (oxaliplatin) presented with acute bilateral loss of vision, headache and confusion 16 hours after the first dose of Avastin was administered. A physical examination of the patient showed that she had high blood pressure, enlargement of the liver and bilateral cortical visual loss with normal optic fundi. The physicians said this clinical presentation and the patient's imaging results were characteristic of RPLS. After stringent blood-pressure control, the patient's vision improved rapidly to a full recovery by the third day. The physicians involved in this case said Avastin may have induced vasospasm, which, along with the patient's hypertension, led to RPLS.

In a response to the physicians' letters, Genentech's Dr. Hal Barron wrote, "We agree that the two patients reported meet the clinical criteria for RPLS. At this time, we are reviewing the global safety database to look for cases with clinical signs and symptoms associated with RPLS and are investigating one additional case."

Roche spokesman Alexander Klauser said in a Reuters article that "[t]his is a very rare syndrome and it is reversible as well. We will be updating regulators with these findings so prescribers can change treatment as required. We are not aware of any additional cases."

According to Reuters, Genentech will work with the FDA to add information about the potential risk for RPLS to the drug's label.

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New hepatotoxicity information added to Tracleer label Actelion Pharmaceuticals U.S. Inc. and the Food and Drug Administration notified health care providers that new hepatotoxicity.