• March 13, 2019
• CMZ Law
• no comments

Why don’t the warning labels on Actemra list its most dangerous side effects?

According to a June 7, 2017 PharmaLive.com report, Actemra (tocilizumab), an FDA-approved medication manufactured by Roche/Genentech for the treatment of rheumatoid arthritis, has been associated with the deaths of more than 1,000 patients. Especially troubling is that the causes of these deaths are not listed on the drug’s label as among the drug’s potential side effects.

Frightening as this is for patients who have been prescribed Actemra, it is, unfortunately, not an isolated situation. Over the years, a number of theoretically “safe” medications have resulted in serious unpredicted side effects, sometimes resulting in the deaths of unsuspecting patients. If you, or someone in your family, has suffered a severe reaction to a drug, you should be aware that you have legal recourse. A personal injury attorney experienced in product defects will be able to fight to ensure that you and your family receive the compensation you deserve.

What is Actemra used for?

Actemra is a biologic drug approved to treat moderate to severe rheumatoid arthritis (RA) in adults and particular types of juvenile rheumatoid arthritis and idiopathic arthritis in children. Biologic medications are designed to reduce the inflammation which is the primary symptom of rheumatoid arthritis.

How many patients have taken Actemra?

The problems associated with Actemra are not small ones. Since the drug was approved for use in 2010, it has been prescribed to more than three-quarters of a million patients. Many had severe reactions, and for over 1,100 such reactions resulted in fatalities.

Side Effects of Actemra Listed on the Label

The milder side effects listed on the Actemra label include:

• Runny or stuffy nose
• Sinus pain, headache, dizziness
• Sore throat
• Itching
• Mild stomach cramps
• Urinary tract infection (UTI).

The more severe side effects mentioned include:

• Severe stomach pain with constipation
• Bloody, tarry, or clay-colored stools
• Coughing up blood or vomiting
• Painful blistering skin rash upper stomach pain
• Dark urine
• Jaundice

While some of the latter symptoms imply gallbladder or pancreatic involvement, pancreatitis, one of the dangerous side effects observed by doctors in patients taking Actemra, is not listed.

The Serious Unmentioned Side Effects of Actemra

Stat News has reported that the hundreds of people whose deaths were associated with the drug died from cardiovascular and pulmonary complications, other side effects for which Actemra labels carry no warnings. During an investigation of more than 500,000 reports of side effects from rheumatoid arthritis drugs, Stat News found clear evidence that, even though Actemra labels contain no warnings relative to heart attack, stroke, or pancreatitis, the risk of having of experiencing such life-threatening events was as high, or higher, for Actemra patients than for patients taking other biologics that carried warnings of such events.

Numerous doctors have suggested that Actemra has had a significant involvement in the deaths of their patients, suggesting a link between the drug  and cardiovascular events and/or pancreatitis. Various experts who have reviewed the evidence, which although still circumstantial is statistically compelling, recommend that the FDA consider adding a warning label to Actemra that includes the dangers of heart and lung problems and pancreatitis. Because of the time lapses in FDA reporting, it is essential that you be aware of the dangers of any medications that may be prescribed to you or your loved ones. If you suffer a severe medical episode while on a new medication, you should investigate the possibility that the two events are connected and contact a skilled personal injury attorney promptly.