Association of Gabapentin Use and Acute Angle-closure Glaucoma
See: https://www.ncbi.nlm.nih.gov/pubmed/31335554
Note that association is just that, association. In and of itself it does not prove cause and effect. Gabapentin has been on the market in the U.S. for more than a quarter of a century and this (September 2019) is the first we are hearing of this. Moreover, unlike chronic (open-angle) glaucoma, the most common type, which can have an insidious onset, acute angle closure glaucoma is a diagnosis which should be hard to miss. Nevertheless individuals using gabapentin should have a thorough eye exam and have their ocular pressures measured.
FDA warning that Gabapentin and Pregabalin can depress respiration
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin
Serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.
At the request of the FDA Eisai voluntarily recalls Belviq (locaserin).
01-14-2020 Initial FDA Drug Safety Communication
Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin). FDA continues to evaluate the trial results
02-13-2020 follow-up notice
FDA Requests Withdrawal of Weight-Loss Drug Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication -
https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-eisai-drug-safety-communication-fda-requests-withdrawal-weight-loss-drug
Dr. Janet Woodcock, who directed the FDA's Center for Drug Evaluation and Research, noted 2-13-2020 "we're taking steps to notify the public…review of the full clinical trial results shows potential risk of cancer associated with Belviq outweighs the benefit of treatment". Eisai, the manufacturer, has submitted a request to voluntarily withdraw the drug. The FDA first announced that Belviq might have links to cancer in 1-14-2020. At that time the FDA said "we cannot conclude that lorcaserin (Belviq) contributes to the cancer risk…and will communicate our final conclusions and recommendations when we have completed our review." The study in question was completed in June. The data showed that while 7.1% of those taking a placebo developed cancer the number rose to 7.7% among those taking Belviq. "A range of cancer types was reported…several different types of cancers occurred more frequently among patients treated with Belviq, including pancreatic, colorectal and lung cancer. During the trial, one additional cancer per 470 patients treated with the medication for one year was observed…the FDA is not recommending special screening for patients who have taken Belviq," Woodcock said.
https://www.webmd.com/diet/obesity/news/20200214/fda-requests-market-withdrawal-of-diet-drug-belviq-due-to-cancer-risk
See next section, heading "Belviq" to see sample of letters written to FDA by patients and families of patients expressing their concerns with respect to Belviq no longer being available.
Response from Dr. Janet Woodcock to a letter from the family of a patient have good response to Belviq
From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Date: Tue, Feb 18, 2020, 12:32 PM
Subject: thank you for writing.
To:
The reason Belviq was asked to withdraw is that the drug was never studied for seizure disorders and was not approved for such. I personally was not aware that it was being used for this indication. FDA will work with the firm and the community over access to the drug, we understand the benefit/risk ratio is very different for seizure disorders that are not well controlled, as compared to use in obesity to achieve modest weight loss. We also understand the time issue here.
Thank you for writing.
Janet Woodcock M.D.
Eisai medical information at 888-274-2378 confirms that the company is in discussions with the FDA about the use of Belviq to treat epilelpsy.
See: https://www.ncbi.nlm.nih.gov/pubmed/31335554
Note that association is just that, association. In and of itself it does not prove cause and effect. Gabapentin has been on the market in the U.S. for more than a quarter of a century and this (September 2019) is the first we are hearing of this. Moreover, unlike chronic (open-angle) glaucoma, the most common type, which can have an insidious onset, acute angle closure glaucoma is a diagnosis which should be hard to miss. Nevertheless individuals using gabapentin should have a thorough eye exam and have their ocular pressures measured.
FDA warning that Gabapentin and Pregabalin can depress respiration
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin
Serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.
At the request of the FDA Eisai voluntarily recalls Belviq (locaserin).
01-14-2020 Initial FDA Drug Safety Communication
Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin). FDA continues to evaluate the trial results
02-13-2020 follow-up notice
FDA Requests Withdrawal of Weight-Loss Drug Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication -
https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-eisai-drug-safety-communication-fda-requests-withdrawal-weight-loss-drug
Dr. Janet Woodcock, who directed the FDA's Center for Drug Evaluation and Research, noted 2-13-2020 "we're taking steps to notify the public…review of the full clinical trial results shows potential risk of cancer associated with Belviq outweighs the benefit of treatment". Eisai, the manufacturer, has submitted a request to voluntarily withdraw the drug. The FDA first announced that Belviq might have links to cancer in 1-14-2020. At that time the FDA said "we cannot conclude that lorcaserin (Belviq) contributes to the cancer risk…and will communicate our final conclusions and recommendations when we have completed our review." The study in question was completed in June. The data showed that while 7.1% of those taking a placebo developed cancer the number rose to 7.7% among those taking Belviq. "A range of cancer types was reported…several different types of cancers occurred more frequently among patients treated with Belviq, including pancreatic, colorectal and lung cancer. During the trial, one additional cancer per 470 patients treated with the medication for one year was observed…the FDA is not recommending special screening for patients who have taken Belviq," Woodcock said.
https://www.webmd.com/diet/obesity/news/20200214/fda-requests-market-withdrawal-of-diet-drug-belviq-due-to-cancer-risk
See next section, heading "Belviq" to see sample of letters written to FDA by patients and families of patients expressing their concerns with respect to Belviq no longer being available.
Response from Dr. Janet Woodcock to a letter from the family of a patient have good response to Belviq
From: Woodcock, Janet <Janet.Woodcock@fda.hhs.gov>
Date: Tue, Feb 18, 2020, 12:32 PM
Subject: thank you for writing.
To:
The reason Belviq was asked to withdraw is that the drug was never studied for seizure disorders and was not approved for such. I personally was not aware that it was being used for this indication. FDA will work with the firm and the community over access to the drug, we understand the benefit/risk ratio is very different for seizure disorders that are not well controlled, as compared to use in obesity to achieve modest weight loss. We also understand the time issue here.
Thank you for writing.
Janet Woodcock M.D.
Eisai medical information at 888-274-2378 confirms that the company is in discussions with the FDA about the use of Belviq to treat epilelpsy.