Merck researcher says all COX-2s may carry heart risk

Share this article:
All COX-2s may cause heart problems or strokes, a Merck researcher said during day one of the FDA's three-day joint session to gather safety data and make recommendations on the future of the drug class.
Ned Braunstein, senior director of Merck Research Laboratories, told two panels of FDA advisers that since his company pulled Vioxx from the market in September, studies suggesting similar problems with Celebrex and Bextra prompted him to come to the conclusion – a change in stance from Merck's earlier position that such health issues appeared to be limited to Vioxx.
"The data strongly suggest it is a class effect," Braunstein said.
Lourdes Villalba, an FDA medical officer responsible for Vioxx the agency's Center for Drug Evaluation and Research, told the panels there were preliminary indications of heart problems with Vioxx before it was withdrawn, but it was difficult to sort through conflicting data.
"We were not asleep at the wheel, we were actually engaged in reviewing a lot of data," Villaba told the joint meeting of the FDA's arthritis advisory committee and its drug safety and risk management advisory committee.
Villalba pointed out that a study done in 200 people comparing Vioxx with pain killer naproxen, showed a higher rate of heart problems with Vioxx, but other studies had conflicting results. In talks with Merck, she said, the company suggested naproxen might have a heart protective effect.
Nonetheless, in 2002 the FDA required an added warning on the Vioxx label urging caution in prescribing it for people with heart conditions.
The committees also explored the safety of Pfizer's COX-2s Celebrex and Bextra.  
Pfizer vice president Joseph Feczko said the reports of increased heart problems in need to be seen in context, considering COX-2s bring a benefits of reducing stomach and intestinal problems that occur with other painkillers.
Kenneth Verberg, Pfizer vice president for inflammation and immunology, defended Celebrex as safe, despite clinical trial results linking it to increased heart risks.
There is little data on the use of Celebrex for more than a year and further long-term testing is needed, Verberg said.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.