Tarceva Side Effects Could Include Stevens-Johnson Syndrome: FDA

The FDA announced Friday that new warnings will be added to the cancer medication Tarceva, indicating that possible side effects could include an increased risk gastrointestinal problems, eye disorders and skin conditions consistent with Stevens Johnson syndrome and toxic epidermal necrolysis.

Tarceva (erlotinib), which was first introduced in 2004 by Genetech Inc. and OSI Pharmaceuticals, is approved by the FDA to treat lung cancer and pancreatic cancer.

The medication is part of a class of drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, which block production of the EGFR protein that is believed to be a factor in the growth of cancer cells.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

According to an FDA MedWatch alert issued on May 8, 2009, new safety information will be added to the warnings and precautions section of the drug’s label about reports of users who developed gastrointestinal perforation, ocular disorders, bullous, blistering and skin conditions that were suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, including some fatalities.

Gastrointestinal perforation involves the development of holes in the wall of the stomach, small intestine or large bowel. It allows the intestinal contents to flow into the abdominal cavity, potentially resulting in peritonitis, emergency surgery or death.

Individuals who are taking Tarceva together with an anti-angiogenic agent, corticosteroid, NSAID or taxane-based chemotherapy and those who have a history of peptic ulcers or diverticular disease could face an increased risk of the Tarceva gastrointestinal side effects.

The eye problems associated with Tarceva have included corneal perforation, corneal ulceration, abnormal eyelash growth, keratoconunctivitis sicca or keratitis, which could threaten or impair sight. Doctors have warned to stop or interrupt use of Tarceva if patients problems such as eye pain.

Tarceva use has also been associated with serious and potentially life threatening skin conditions, such as bullous, blistering and possibly Stevens-Johnson syndrome, which causes the skin to burn from the inside out. Severe cases of Stevens-Johnson syndrome are referred to as toxic epidermal necrolysis, which involves situations where more than 30% of the body is covered by skin lesions.

According to the FDA, fatalities have been associated with the possible Tarceva Stevens-Johnson syndrome side effects and gastrointestinal perforations.

This alert is the second time in the past year that the manufacturers have updated the Tarceva warning label about potentially life-threatening problems. In September 2008, a was sent letter to healthcare professionals warning about other potential Tarceva side effects, including a risk of liver failure, hepatorenal syndrome and death.

10 Comments

  • CarolApril 29, 2016 at 2:09 am

    My husband was on tarceva for about 10 months. His Lung cancer went into remission but soon after he loss use of hands,feet and memory. One week later he died after being released from hospital. Oncologist never he called us. Made me very suspicious.

  • RonJanuary 8, 2016 at 10:41 pm

    My mother never smoked a day in her life but ended up with stage 4 lung cancer. The MD said it was terminal and she would die from it but with Tarceva she could live considerably longer. Sadly, she accepted. Shortly thereafter she was diagnosed with Stevens Johnson Syndrome. She died from this terribly painful syndrome in weeks. When she was told she had cancer, she was told she would live 6 mon[Show More]My mother never smoked a day in her life but ended up with stage 4 lung cancer. The MD said it was terminal and she would die from it but with Tarceva she could live considerably longer. Sadly, she accepted. Shortly thereafter she was diagnosed with Stevens Johnson Syndrome. She died from this terribly painful syndrome in weeks. When she was told she had cancer, she was told she would live 6 months to a year with no treatment. With Tarceva, she passed approximately 4 months from diagnosis. Worst death ever.

  • SandySeptember 15, 2013 at 5:40 am

    My mom was diagnosed with lung cancer had radiation and chemo and came thru it all well didn't even lose her hair, Her doctor put her on tarceva and with in 3 mos. my mom went from 140 lbs to 108lbs , having severe diarehea and needing to wear a diaper , her memory was gone.. she went from an extremely active smart woman to a woman who would call me crying because she didn't know how to turn her [Show More]My mom was diagnosed with lung cancer had radiation and chemo and came thru it all well didn't even lose her hair, Her doctor put her on tarceva and with in 3 mos. my mom went from 140 lbs to 108lbs , having severe diarehea and needing to wear a diaper , her memory was gone.. she went from an extremely active smart woman to a woman who would call me crying because she didn't know how to turn her tv on. I showed up to find her sitting in the dark in front of her dark tv. Yet she has been in remission for over a year but at what cost? I took her off the tarceva but the damage .

  • lauraSeptember 24, 2012 at 2:44 pm

    My Mom fought through chemo, radiation, heart surgery, brain surgery, blood clots and excessive fluid in her lungs. Every time they told us "This is it" she fought and got better. However, once they put her on Tarceva it was a quick downward spiral. They never told us of ANY side effects. She had a rash all over her body and severe eye infections but when we asked why this was happening, the d[Show More]My Mom fought through chemo, radiation, heart surgery, brain surgery, blood clots and excessive fluid in her lungs. Every time they told us "This is it" she fought and got better. However, once they put her on Tarceva it was a quick downward spiral. They never told us of ANY side effects. She had a rash all over her body and severe eye infections but when we asked why this was happening, the doctors said they didn't know. After about two months of being on the medication she never walked again and was bedridden for the last six months of her life. She passed away but it wasn't the cancer. It was respiratory failure due to lung cancer. I know the Tarceva, which was supposed to enhance and elongate her life, robbed her of the little time she had left. It was horific to witness.

  • SandraApril 9, 2011 at 2:43 pm

    My husband was on a chemo regime for over a year doing very well when he was then switched to Tarceva. from the time he went on Tarceva he went down hill and when his Taceva dose was increased in spite of all the side effects he had already had and despite my strong expressed objections within a VERY short time he died. I do believe it wasn't the cancer that killed him because MRI and petscans sh[Show More]My husband was on a chemo regime for over a year doing very well when he was then switched to Tarceva. from the time he went on Tarceva he went down hill and when his Taceva dose was increased in spite of all the side effects he had already had and despite my strong expressed objections within a VERY short time he died. I do believe it wasn't the cancer that killed him because MRI and petscans showed no significant change in the cancer and some nodes had even shrunk while he was on Alitma. he never should have been changed to Tarceva. I knew it in my gut , had a break down trying to convey it to the onocologist that it was making him worse and no one listened. they don't want their decisions and experiments questioned. I wouldn't ever take tarceva or let another relative take it.I watched how he suffered from the time he took it- head aches all night long, getting weaker and weaker,shaking so he couldn't write, leg aches, throwing up his lunch everyday,excessive rash all over his body(that the onocologist even asked us to take photos of because he said it was excessive).

  • nicholasDecember 1, 2010 at 6:16 pm

    my girlfriend is diagosed with lung cancer stage 4 and she took the drug for two weeks and had the same symtons and right now she is still at the hospital recovery frm these symtons, they want to put her back on the drug am trying to explain to her not to take it but she doesnt want to listen,i dont know what to do plse help.

  • CindiNovember 7, 2010 at 1:28 am

    My Father was diagnosed with lung cancer in March 2010. He was started on Tarceva and was just told by his MD it may cause a rash. It caused severe nausea and within 4 days, on April 1st, 2010, he died of liver failure. It was only 3 weeks after being diagnosed and the 4th day of the medication.

  • LucySeptember 21, 2010 at 5:36 pm

    My mother was diagosed with NSCLC in Oct of 09, after undergoing several other chemo tx, and radiation, her Dr. (Dr. Leonardo Forero @ Tx Onclology) placed her on Tarceva with out disclosing the major side affects, or giving her a regime ( I had to look it up on line) on July 28, 2010, she quit taking it 21 days later after losing 13 pounds in 4days, unable to breath, and unalbe to get to the rr [Show More]My mother was diagosed with NSCLC in Oct of 09, after undergoing several other chemo tx, and radiation, her Dr. (Dr. Leonardo Forero @ Tx Onclology) placed her on Tarceva with out disclosing the major side affects, or giving her a regime ( I had to look it up on line) on July 28, 2010, she quit taking it 21 days later after losing 13 pounds in 4days, unable to breath, and unalbe to get to the rr on her own. She was place in the Hospital on 8/25/2010, Hospice on the 29th of Aug, and she passed away on September 5, 2010, after suffering for 3weeks, of not breathing, panic attacks, broken ribs, and so forth.. This drug is bad, and you need to make sure you ask all questions for this drug/poison. It enhanced her death, shortened her life, and made her suffer>>>>>>>

  • brendaAugust 31, 2010 at 5:59 pm

    my husband was diagnosed with stage 4 lung cancer. He began taking tarceva in oct.2009.He began experiencing severe stomach pain. He reduced the dosage to every other day instead of taking it daily.After taking only 5 doses he was admitted to the hospital and passed away on oct.26th 2009.He developed severe periontinitis and his cause of death was listed as severe periontinitis caused by use of t[Show More]my husband was diagnosed with stage 4 lung cancer. He began taking tarceva in oct.2009.He began experiencing severe stomach pain. He reduced the dosage to every other day instead of taking it daily.After taking only 5 doses he was admitted to the hospital and passed away on oct.26th 2009.He developed severe periontinitis and his cause of death was listed as severe periontinitis caused by use of tarveva.

  • CarissaDecember 4, 2009 at 5:39 am

    My grandfather began taking Tarceva in October of 2009. After taking it for a month and a half he began showing little blisters all over his body. He then began to lose strength in his legs, so he stopeed taking the Tarceva and now 3 weeks later cannot move his legs at all. Could the Tarceva have been what has caused the loss of movement in his legs?

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024
Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024 (Posted 2 days ago)

A federal judge is allowing plaintiffs to file large numbers of Suboxone tooth decay lawsuits in one bundled complaint, to meet a potential two-year statute of limitations deadline, with the ability to flesh those claims out in more detail at a later date.