| In yet another case of NSAID-related labeling change, | | | | lethargy, diarrhea, pruritus, jaundice, right upper quadrant |
| all products containing diclofenac sodium are now | | | | tenderness and flu-Like symptoms. |
| required to include stronger warnings and precautions | | | | 4. Exercise caution when prescribing diclofenac with |
| about possible liver toxicity. The call for change came | | | | drugs that are known to be potentially hepatotoxic (e.g. |
| after post-marketing reports found that Voltaren, a | | | | antibiotics and anti-epileptics). |
| diclofenac sodium topical gel used for the relief of | | | | Labeling change for NSAIDs and other drugs are not |
| osteoarthritis-induced pain, could cause serious liver | | | | new. In 2005, following the voluntary withdrawal of |
| reactions, including liver necrosis, jaundice, hepatitis and | | | | Vioxx from the market in the previous year, the FDA |
| liver failure. Some of these reported cases have also | | | | requested all prescription and over-the-counter NSAIDs |
| resulted in the need for a liver transplant or even | | | | to add new warnings and precautions to warn patients |
| death. But the exact number of reported cases of | | | | about cardiovascular and gastrointestinal bleeding risk. |
| adverse effects associated with Voltaren gel is | | | | Vioxx is a type of NSAID known as COX-2 inhibitor |
| unknown. | | | | that targets a specific enzyme believed to be |
| In a letter to health care professionals, the FDA and | | | | responsible for causing inflammation in the body. But, |
| the manufacturers highlighted the new warnings and | | | | this drug has been found to increase the risk of heart |
| precautions which apply to all diclofenac sodium | | | | attack even at low doses, which led to its downfall. |
| products. They warned that diclofenac sodium, a | | | | After the withdrawal of Vioxx, Bextra, another |
| non-steroidal anti-inflammatory drug, may cause liver | | | | COX-inhibitor, was also removed from the market. |
| damage. Symptoms of drug-induced liver abnormalities | | | | The latest warnings for diclofenac sodium add to the |
| may appear within the first or second month of | | | | long list of potential side effects of NSAID use. NSAIDs |
| therapy, but can also occur at any time during | | | | have been known for causing gastrointestinal |
| treatment with diclofenac. | | | | complications like stomach ulcer and bleeding, |
| To prevent severe liver damage, physicians are | | | | hypertension, skin reactions, kidney problems, as well |
| recommended to take the following precautions: | | | | as increase the risk of cardiac events such as heart |
| | | | attack and stroke. |
| 1. Give patients the lowest effective dose of | | | | But despite the possible side effects, NSAIDs |
| diclofenac for the shortest possible duration. | | | | continued to be used widely throughout the world. In |
| 2. Closely monitor transaminases in patients who are | | | | the US alone, some 60 million prescriptions are written |
| using diclofenac on a long-term basis. | | | | for NSAIDs per year, and many of them are for |
| 3. Inform patients to look out for warning signs of | | | | elderly patients who are more susceptible to the |
| diclofenac side effects, such as nausea, fatigue, | | | | adverse reactions of NSAIDs. |