High doses of a drug used to treat Alzheimer’s disease— donepezil hydrochloride, sold under the brand name Aricept—might be ineffective and cause serious adverse reactions, according to the group Public Citizen.
What Is Aricept? When Is It Prescribed?
The Japanese pharmaceutical company Eisai Co., Ltd. developed Aricept and partnered with the American pharmaceutical giant Pfizer, Inc. to distribute it in the United States. The U.S. Food and Drug Administration (FDA) approved the drug in 1996 for mild-to-moderate dementia characteristic to Alzheimer’s disease at 5 mg and 10 mg doses, then for moderate-to-severe cases of Alzheimer’s in 2006 at 10 mg, and finally at 23 mg for severe cases of Alzheimer’s in 2010. According to SDI Health’s Vector One national database, in 2010 Eisai and Pfizer earned $1.5 billion in Aricept sales in the United States based on six million prescriptions, making it a very lucrative drug.
Scientists believe that symptoms of Alzheimer’s disease are caused by a deficiency of the neurotransmitter acetylcholine, which affects the brain’s arousal and reward systems, attention system, and memory system. Donepezil inhibits the acetylcholinesterase enzyme from breaking down acetylcholine thereby reducing symptoms of Alzheimer’s dementia.
Aricept Might Cause Side Effects at High Doses
Controversy over Aricept erupted in May 2011, when the consumer advocacy organization Public Citizen submitted a petition to the FDA asking the agency to order an Aricept recall of the 23 mg version of the drug and change the drug’s label to discourage physicians from advising patients to use 20 mg of the drug during treatment. Eisai and Pfizer obtained approval for the 23 mg donepezil dose to treat severe Alzheimer’s disease in 2010 for the next three years, and Public Citizen believed they did so only to maintain their patent protection on the drug, not to help those suffering from the disease.
In particular, Public Citizen pointed to a clinical trial comparing the efficacy of 23 mg donepezil to 10 mg donepezil. Tested four times total, researchers found in three tests that the 23 mg dose was no more effective at curbing Alzheimer’s disease symptoms, and in the fourth test the slight benefits of the 23 mg dose were not statistically significant. The FDA’s own clinical and statistical reviewers gave negative reviews to the 23 mg version of Aricept, but even after acknowledging their findings the FDA’s Division Director of Neurology Products, Dr. Russell Katz, decided to approve the drug anyway.
People who take the 23 mg version of donepezil can experience the following reactions:
- Massive gastrointestinal bleeding
- Esophageal rupture
The press release accompanying Public Citizen’s petition quotes Johns Hopkins University School of Medicine professor Thomas Finucane as saying, “Cholinesterase inhibitors such as Aricept have gained multibillion-dollar success due primarily to two factors: the understandable desperation of those who care for patients with Alzheimer’s disease, and a relentless promotional campaign by drug companies.”
More than one year after it petitioned the FDA to recall the 23 mg version of Aricept, in September 2012 Public Citizen sued the agency to force it to act on its petition.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Aricept lawsuit on your behalf if necessary.
If you have taken Aricept and believe it harmed you, contact RLG today.