FDA orders Waltham firm to caution drug's users

A Waltham pharmaceutical firm is among several antibiotic manufacturers being told by federal regulators to place a prominent "black box" warning on its drug.

The Food and Drug Administration said yesterday that it has found evidence that fluoroquinolone drugs may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.

The FDA ruling applies to top sellers Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. It also applies to Factive, an antibiotic made by Waltham's Oscient Pharmaceuticals Corp.

In a regulatory filing, the company said it will work with the FDA to implement changes to the labels.

Oscient said it received three reports of tendon-related side effects from Factive, which has been taken by 1.6 million people in the United States since it hit the market in September 2004.

Tendon ruptures are normally thought of as sports injuries, generally occurring among men in their mid-30s. The link to treatment with the antibiotics is highly unusual, and scientists still don't fully understand why it happens.

Source: Boston Herald, Author: Christine McConville

Source: http://www.bostonherald.com/

Comments: Along with Waltham pharmaceuticals, many other antibiotics makers of fluoroquinolone antibiotics including frequently prescribed medications as Cipro by Bayer and Levaquin by J&J, will have to up the strongest "black box" warning about an important side effect – possibility of tendon rupture – on these antibiotics. Tendon rupture is usually a sports injury and can leave the person incapacitated or requiring extensive surgery. The information of such side effect already exists on the label, however now the FDA has arrived to a conclusion that it is more prevalent than anticipated and therefore requires to be separately listed and not among the myriad of other possible side effects. Public Citizen group, a health advisory group, which first brought this to the attention of FDA, reports 407 tendon ruptures 341 reports of tendonitis in 2007 alone attributed to the use of these antibiotics. The ruling applies to all fluoroquinolone drugs, including ciprofloxacin (Cipro and generic ciprofloxacin), ciprofloxacin extended release (Cipro XR and Proquin XR), moxifloxacin (Avelox), gatifloxacin (Tequin), gemifloxacin (Factive), levofloxacin (Levaquin), norfloxacin (Noroxin) and ofloxacin (Floxin and generic ofloxacin).

Although Cipro was considered a higher potency antibiotic, it has now become a very commonly used antibiotic drug and therefore potential risk of this debilitating side effect has now gained importance. Most at risk are, transplant patients, individuals older than 60 and people who are on steroids. The benefit of this increased information is that patients can be aware and can take action if they experience pain or swelling in a tendon after starting the medication.