Side effects from famotidine are usually mild and include headache, dizziness, constipation, diarrhea and fussiness, however more serious effects such as hives, skin rashes and swelling have been reported. While reports of TEN associated with famotidine are rare, the condition can be life threatening.

SJS/TEN have been associated with as many as 2,000 medications, most often NSAIDs, antibiotics and anti-seizure drugs. SJS/TEN begins with a rash that blisters over causing the skin to slough off in sheets. Blisters can also form on the mucous membranes affecting the eyes, nose, mouth and genitals.

Famotidine is not a proton pump inhibitor (PPI) and thus was not among the heartburn drugs cited by a recent Food and Drug Administration (FDA) warning about the increased risk of wrist, hip and spine fractures with PPIs. Another heartburn medication, Reglan (metoclopramide), has also fallen under an FDA black box warning after reports of consumers who took the medication developed a serious movement disorder known as Tardive Dyskinesia.

SOURCE: Stevens Johnson Syndrome › Pepcid linked to serious skin reaction

Darunavir, manufactured by Tibotec, belongs to a class of anti-HIV drugs called protease inhibitors (PI). It works to prevent cells infected by HIV from producing new virus, thus reducing the amount of virus in the body. Darunavir must be coadministered with 100-mg ritonavir and with other antiretroviral agents. It was approved by the FDA in June 2006 for HIV-positive adults who were treatment-experienced.

Last October, darunavir was approved for HIV-positive individuals beginning treatment. The medication has proven effective for patients who are not likely to respond to older PIs and for those who are starting antiretroviral therapy for the first time.

SJS and its more severe form, toxic epidermal necrolysis (TEN), are serious adverse reactions to medication. The reaction begins with a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes in the eyes and mouth also can blister over, leading to dehydration, infection, blindness, and even death. More than 200 medications have been linked to SJS and TEN, including NSAIDs such as ibuprofen, antibiotics and anti-seizure medication.

Other warning included in the labeling revisions for darunavir include warnings of potential drug-drug interactions and pregnancy risk. Darunavir should not be taken with dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. John’s Wort, lovastatin, simvastatin, or rifampin.

Darunavir also should be taken during pregnancy only if the potential benefit justifies the potential risk, according to the report. Mothers on darunavir should not breast feed, and children younger than 3 should not take darunavir.

SOURCE: Stevens Johnson Syndrome › HIV medication carries warning of SJS

Modafinil (Provigil) is approved by the FDA to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea. Modafinil (Provigil) also has been shown effective in the treatment of depression, cocaine addition, Parkinson’s Disease and schizophrenia, though the FDA has not approved the drug for those conditions. It also was thought to be an effective treatment for Attention-Deficit Hyperactivity Disorder (ADHD), however in 2006 it was rejected by the FDA for use by children for ADHD. Cephalon now discourages the drug’s use in children for any purpose.

Since December 1998, when Modafini (Provigil) was introduced to the market until January 30, 2007, seven cases of seven cases of severe cutaneous adverse reactions to the medicine were reported to the FDA. Those cases included SJS and its more severe form, toxic epidermal necrolysis (TEN).

SJS and TEN has a reported incidence rate of about one case per million people each year. It is most often caused by an adverse reaction to medication. Medications that have been linked to SJS and TEN include NSAIDS (non-steroidal anti-inflamatory agents), anti-seizure medications and some antibiotics.

SOURCE: Stevens Johnson Syndrome › Stimulant drug added to list of meds that can cause SJS/TEN