Epipen

What the EpiPen Recall Might Mean for You

EpiPen and EpiPen Jr auto-injectors distributed between December 2015 through July 2016 are being recalled. 

In early April,  pharmaceutical company Mylan NV announced a recall of certain brand name EpiPen products. The flaw in the recalled devices means that in a case of emergency, patients could face serious health risks. EpiPen

In a public statement, Mylan stated that “this recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component.”

Mylan’s EpiPen, expanded its recall of the popular auto-Injectors to the U.S. In the recall announcement, Mylan made it clear that they would be readily available to replace the recalled devices. 

Epipen
Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions.

Further, the pharma giant stated that “there will be no additional replacement-related financial burden to them as a result of this recall.” 

Patients with the recalled auto-injectors could face serious consequences from anaphylaxis. Anaphylaxis is a life-threatening allergic reaction to things like insect bites, food, and medication. 

The recalled product was manufactured by Pfizer’s Meridian Medical Technologies and was distributed between December 2015 and July 2016 by Mylan Specialty.

If you or your loved one have been put at risk by the EpiPen or any other Mylan product, contact the legal professionals at Medical Claim Legal.

Chantix

Violations during Chantix Trial Lead to FDA Warning Letter

Physician faces FDA Warning after ignoring protocol during a clinical trial.

A Chantix trial has ruffled the feathers of the FDA. Dr. Cassandra Curtis, an Indianapolis-based physician received an FDA warning letter after failing to follow drug protocol at her clinic.Chantix

The approved plan for Chantixa smoking cessation drug, required that patients participating in a trial meet certain guidelines. The FDA accused the doctor several violations including keeping “inadequate records” of the amount of the drug being distributed.

Guidelines insisted that patients enrolled in the trial must “smoked an average of at least 10 cigarettes a day during the past year.” 3 of the patients did not meet this requirement.

Dr. Curtis also included a patient in the study with a pre-existing condition which should have disqualified them. One chronic obstructive pulmonary disease patient was enrolled.

Other accusations in the warning letter accused the doctor of failing to maintain adequate patient records, therefore compromising a collection of useful data.

These violations are serious ones as the FDA warning notes that they compromise “safety and welfare.”

Chantix Suicide Risks and Bizarre Behaviors

Chantix and it’s maker Pfizer have already had a share of controversy as the drug has been tied to increased suicide risk. Other bizarre behavior was documented when one user faked his death.

Business Insider documented other specific “changes in behavior” seen amongst Chantix users:

  • In July 2012, a plaintiff named Eric Hall sued Pfizer, claiming Chantix made him rob a toll collector, wreck his car, and land in jail, according to this personal injury blog.
  • In May 2011, MSNBC reported regulators were overlooking serious psychotic reactions to the drug, citing a study by the non-profit Institute for Safe Medication Practices.
  • That study found a 24-year-old woman on the drug started beating her boyfriend because he looked “peaceful,” MSNBC reported.
  • The study also found a 42-year-old man punched a stranger at a bowling alley.
  • In September 2007, The New York Times reported the late indie rocker Carter Albrecht – described by friends as even-tempered – had assaulted his girlfriend while on the drug.
  • And in February 2008, New York Magazine ran this first-person piece called “This Is My Brain On Chantix,” in which the author claimed the drug spurred “self-destructive fantasies.”

Chantix Legal Representation

Pfizer has fought tooth and nail to remove warnings about the suicide risks. The company has attempted to provide evidence to the FDA, in the form of clinical trials, that demonstrate that there is no connection between the treatment and a suicide risk. However, the money trail has presented a troubling pattern.

After performing a review of Pfizer’s financial disclosures, the FDA found that investigators at 32 sites where the trial was being performed were paid $25,000 or more by the Chantix drugmaker Pfizer.

If you or a loved one used Chantix and experiences adverse effects, you could be entitled to financial compensation. The Medical Claim Legal team could get you the help that you need.