Interestingly enough for a press release they do provide more text about side effects and dangers of using Stelara than the actual announcement of phase III:
Important Safety Information (U.S.)
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you think you have an infection or have symptoms of an infection such as:
fever, sweats, or chills
muscle aches
cough
shortness of breath
blood in your phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinate more often than normal
feel very tired
are being treated for an infection
get a lot of infections or have infections that keep coming back
have TB, or have been in close contact with someone who has TB
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).
STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA® will get any of these infections because of the effects of STELARA® on these proteins.
Cancers
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.
Before receiving STELARA®, tell your doctor if you:
have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS
ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
are allergic to latex. The needle cover on the prefilled syringe contains latex.
have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®.
have any new or changing lesions within psoriasis areas or on normal skin
are receiving or have received allergy shots, especially for serious allergic reactions
receive or have received phototherapy for your psoriasis
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®
are breast-feeding or plan to breast-feed. It is thought that STELARA® passes into your breast milk. You should not breast-feed while taking STELARA® without first talking to your doctor.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Please read the Full Prescribing Information, including the Medication Guide for STELARA®, and discuss any questions you have with your doctor.
Important Safety Information (EU)4
Special Warnings & Precautions
Infections: Potential to increase risk of infections and reactivate latent infections. Exercise caution in patients with a chronic infection or history of recurrent infection, particularly TB. Patients should be evaluated for tuberculosis and treated for latent TB prior to initiation of STELARA®. Also, consider anti-tuberculosis therapy prior to initiation of STELARA® in patients with past history of latent or active tuberculosis. Patients should seek medical advice if signs or symptoms suggestive of an infection occur. If a serious infection develops, they should be closely monitored and STELARA® should not be administered until infection resolves.
Malignancies: Potential to increase the risk of malignancy. No studies have been conducted in patients with a history of malignancy or in those who continue to receive STELARA® after being diagnosed with a malignancy. Exercise caution when considering STELARA® in these patients. Monitoring for the appearance of non-melanoma skin cancer recommended, in particular for patients greater than 60 years of age, or with a medical history of prolonged immunosuppressant therapy or a history of PUVA treatment.
Hypersensitivity reactions: Serious hypersensitivity reactions (anaphylaxis and angioedema) reported, in some cases several days after treatment. If these occur, institute appropriate therapy and discontinue use of STELARA®.
Vaccinations: Patients receiving STELARA® should not receive concurrent live viral or live bacterial vaccines such as BCG. Before live viral or live bacterial vaccination, treatment with STELARA® should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Patients receiving STELARA® may receive concurrent inactivated or non-live vaccinations.
Concomitant immunosuppressive therapy: Exercise caution, including when changing immunosuppressive biologic agents. In psoriasis studies, the safety and efficacy of STELARA® in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA®.