You are here

Myasthenia Gravis Symptoms Exacerbated by Ketek, Health Care Providers Warned

Strasbourg France – April 16, 2003 - Aventis announced today that it is in the process of proactively providing healthcare professionals with information about the potential for exacerbation of symptoms of myasthenia gravis in patients with myasthenia gravis taking Ketek. Myasthenia gravis is a rare autoimmune disease that causes muscle weakness.

To date, there have been 10 reported cases of exacerbation of myasthenia gravis in patients taking Ketek (out of over 2.7 million Ketek prescriptions worldwide). All reported cases have been in patients previously diagnosed with myasthenia gravis. This precaution is specific to myasthenia gravis patients. Aventis will also be adding this precaution to its current summary of product characteristics (SPC) labeling in countries where Ketek has already been launched and will update the labeling in countries where it has applied for registration.

Exacerbation of myasthenia gravis has been reported with patients taking medications from many different therapeutic classes, including various antibiotics.

Ketek is the first of a new class of antibiotics known as the Ketolides for first line treatment of acute exacerbation of chronic bronchitis (AECB), sinusitis, and community acquired pneumonia (CAP), including those caused by resistant pathogens - with less propensity to induce resistance - and a short treatment regimen. Ketek was first launched in October 2001 in Germany and has been approved in all EU and major Latin American markets.

In clinical trials, the most commonly reported side effects (2 percent) were diarrhea, nausea and vomiting.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks