Drug Safety Developments

Will the FDA Ever Push the MiraLAX Pediatric Study?

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Throughout our previous articles on the topic, we often discuss how the Children’s Hospital of Philadelphia (CHOP) has had a seemingly endless delay in their study on the effects of PEG 3350 (the main ingredient in MiraLAX) in children.  A study that was originally supposed to be completed in 2015 and then by the end of 2018, is still incomplete.  You can read our January 2018 article, “MiraLax Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018", for more details about the study itself.

 

Concerns Resurfacing

An interesting New York Times article from 2015 was recently brought to our attention.  Within the article, “Scrutiny for Laxatives as a Childhood Remedy”, is what the FDA had to say about the then-upcoming CHOP study:

The new study in Philadelphia will address how PEG 3350 is metabolized by children and whether they have evidence of toxins in their blood.  "Due to the frequent use of PEG 3350 products in children," Mr. Ventura said, "we believe further study is warranted to understand the absorption of [ethylene glycol (EG)] and [diethylene glycol (DEG)] by pediatric patients who take these products."

According to this article, scientists of the FDA actually found trace amounts of these chemicals in MiraLAX back in 2008 during testing, as seen here:

Buried in the agency’s brief to researchers, issued [in 2014], was some disquieting news. The F.D.A. said that it had tested eight batches of Miralax and found tiny amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze, in all of them. The agency said the toxins were impurities resulting from the manufacturing process.

Those tests were conducted in 2008, but the results were not disclosed. Jeff Ventura, an F.D.A. spokesman, said batches were tested because “many of the reported adverse events were classic symptoms of ethylene glycol ingestion.”

To be clear, what happened here is that the FDA did their tests on MiraLAX in 2008, but the FDA never disclosed their findings of EG and DEG until the release of this New York Times article in 2015.

 

Safe or Unsafe?

A previous article of ours, “Inconclusiveness of MiraLAX Studies Leading to Frustration for Parents”, discussed a new study which aimed to find out about the long-term use of PEG 3350 in children since the CHOP study was failing.

Within this study there was mention that DEG and EG are “compounds which are neurotoxic at high concentrations” and, back to the New York Times article, we learn:

As it turns out, extremely small amounts of DEG and EG are permitted in finished drug products, and the F.D.A considers the laxatives ‘safe to use in accordance with approved labeling’ - that is, only by adults for not longer than seven days.

Okay so that goes for adults but what about children?

Yet no one knows if small amounts of EG or DEG found in the laxatives or present once metabolized might harm children, especially those given the laxatives chronically.

 

With the information from this New York Times article alongside the information we've talked about in various articles published previously by our firm, we are not left with a whole lot of clarity on the MiraLAX situation.  Our understanding is that this CHOP study which was introduced so long ago has failed in developing the necessary components to complete the study and produce some answers for the very concerned public -- especially parents whose children are suffering. 

From our perspective, now is the time for FDA to actually put forth some effort and get this CHOP study finished.  Or, in the alternative, create a new study about the safety of pediatric MiraLAX use since this CHOP study has seemingly failed for too long.

 

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Xeljanz Safety Concerns and New Precautions

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death.  In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing study on the drug.  The FDA has finally put in place the “Black Box Warning" to draw attention to these serious risks.

 

Treatment and Trials

Xeljanz can be used to treat ulcerative colitis as well as psoriatic or rheumatoid arthritis.  The recent article, “FDA Requires Box Warnings for Pfizer Drug Xeljanz”, relays information from the FDA that the 10 mg dosage twice a day should not be used for the aforementioned types of arthritis, just ulcerative colitis.  Even further, it should only be used for ulcerative colitis if other medications are not sufficient for the patient.

The use of Xeljanz for the treatment of rheumatoid arthritis was discussed in the Milwaukee Journal Sentinel article, “FDA puts stringent warning on the Pfizer drug Xeljanz because of clots and deaths”, noting that:

The FDA also released data from a safety trial of the drug in people with rheumatoid arthritis, showing there were 19 blood clots in the lungs in those who got higher-dose Xeljanz compared with three who got other drugs known as TNF blockers. There also were 45 deaths in those who got high-dose Xeljanz compared with 25 who got TNF blockers.

The "Black Box Warning" came five months after this clinical trial.  The FDA has received public criticism, such as from physician Michael Carome with Public Citizen, for "moving more slowly and less aggressively to protect public health relative to regulators in other countries"

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New Safety Precautions

Medscape also just published an article on the subject, “FDA Adds Boxed Warning on Risk for PE, Death With Higher Dose Tofacitinib (Xeljanz)”, which reports that in May, health officials in Europe had already advised physicians against the twice a day 10 mg dose of the medicine due to high risk of PE.

Edward V. Loftus, Jr., MD, the Chief Medical Editor of Healio Gastroenterology and Liver Disease, notes:

Based on what I have read, I do not know what the actual magnitude of that risk is, in other words, what’s the relative risk or absolute risk for thromboembolism?

But, there must have been some signal at the higher dose that they saw this signal and so, the European's put out the warning and now the FDA is basically putting out the same warning and they are making it a boxed warning.

While this is confusing, we just have to be cognizant of the warning, which is use the lowest dose possible that keeps your patient in remission.

 

As more information and developments arise regarding the safety of Xeljanz, we will make sure to provide updates whenever possible.

You can visit our law firm's website to submit a free case evaluation if you think you or someone you know may have a personal injury or wrongful death lawsuit as a result of Xeljanz side effects.