The FDA has put 12 clinical trials on hold after reviewing troubling data from a Keytruda study. The agency was studying the medication for treatment for multiple myeloma. Several patients died during the study and results showed an over 60% chance of death from using the drug.
Keytruda (Pembrolizumab) is a medication used for various cancer conditions. These conditions can also include advanced melanoma, non-small cell lung cancer, and head and neck squamous cell cancer. Keytruda works by altering the protective mechanism on cancer cells and altering the immune system to destroy cells. Keytruda is a classification of PD-1 and PD-L1 inhibitors. These new class of chemicals helps the body’s immune system recognize cancer cells as foreign.
Keytruda Side Effects
One of the main side effects of Keytruda is causing the immune system to attack normal organs and tissues of the body. This can become life-threatening.
Other side effects include:
- Lung problems such as pneumonitis
- Intestinal holes (colitis)
- Liver problems
- Hormonal and glandular problems
- Kidney failure
- Various other problems with different internal organs
FDA Halts Keytruda Trial
In September 2017, the FDA placed a hold on the Keytruda trials (KEYNOTE-183 and KEYNOTE-185) after several patients using the drug died. Researchers used Keytruda in combination with traditional blood cancer drugs (pomalidomide and lenalidomide) made by Celgene. Under the hold, Bristol-Myers Squibb will not be allowed to enroll new patients in the studies. However, those patients experiencing possible results can still receive the medications.
The FDA does not know if the negative results of the trial are linked to Keytruda combined with dexamethasone and either of two immunomodulatory agents lenalidomide or pomalidomide in multiple myeloma clinical trials. The government agency has not approved Keytruda for treating multiple myeloma. The KEYNOTE-183 trial involved about 250 patients. Those using Keytruda had a 61% increased risk of death. There were 29 deaths in the Keytruda.
However, data from the KEYNOTE-185 clinical trial saw an even higher risk of patient death. This study had around 300 patients and 19 died compared to just 9 in the control group. Trial data also showed that 54% of the patients given a Keytruda-based drug combination had severe adverse health effects, compared to only 39% in the control group.
There are a number of other multiple myeloma clinical trials ongoing that either involve Keytruda or similar drugs. The FDA is investigating those trials to determine if there is a safety issue with them as well.
We Want to Help Keytruda Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If a loved one took Keytruda and died, you should demand accountability. We want to also help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement may give you compensation for their injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if a loved one died from using Keytruda, please speak to us to learn more about your rights.