How Safe Are Non Steroidal Anti Inflammatory Drugs?

In yet another case of NSAID-related labeling change, all products containing diclofenac sodium are now required to include stronger warnings and precautions about possible liver toxicity. The call for change came after post-marketing reports found that Voltaren, a diclofenac sodium topical gel used for the relief of osteoarthritis-induced pain, could cause serious liver reactions, including liver necrosis, jaundice, hepatitis and liver failure. Some of these reported cases have also resulted in the need for a liver transplant or even death. But the exact number of reported cases of adverse effects associated with Voltaren gel is unknown.

In a letter to health care professionals, the FDA and the manufacturers highlighted the new warnings and precautions which apply to all diclofenac sodium products. They warned that diclofenac sodium, a non-steroidal anti-inflammatory drug, may cause liver damage. Symptoms of drug-induced liver abnormalities may appear within the first or second month of therapy, but can also occur at any time during treatment with diclofenac.

To prevent severe liver damage, physicians are recommended to take the following precautions:

  1. Give patients the lowest effective dose of diclofenac for the shortest possible duration.
  2. Closely monitor transaminases in patients who are using diclofenac on a long-term basis.
  3. Inform patients to look out for warning signs of diclofenac side effects, such as nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness and flu-Like symptoms.
  4. Exercise caution when prescribing diclofenac with drugs that are known to be potentially hepatotoxic (e.g. antibiotics and anti-epileptics).

Labeling change for NSAIDs and other drugs are not new. In 2005, following the voluntary withdrawal of Vioxx from the market in the previous year, the FDA requested all prescription and over-the-counter NSAIDs to add new warnings and precautions to warn patients about cardiovascular and gastrointestinal bleeding risk.

Vioxx is a type of NSAID known as COX-2 inhibitor that targets a specific enzyme believed to be responsible for causing inflammation in the body. But, this drug has been found to increase the risk of heart attack even at low doses, which led to its downfall. After the withdrawal of Vioxx, Bextra, another COX-inhibitor, was also removed from the market.

The latest warnings for diclofenac sodium add to the long list of potential side effects of NSAID use. NSAIDs have been known for causing gastrointestinal complications like stomach ulcer and bleeding, hypertension, skin reactions, kidney problems, as well as increase the risk of cardiac events such as heart attack and stroke.

But despite the possible side effects, NSAIDs continued to be used widely throughout the world. In the US alone, some 60 million prescriptions are written for NSAIDs per year, and many of them are for elderly patients who are more susceptible to the adverse reactions of NSAIDs.