Gemfibrozil
Risk Factor: CM
Class: ANTILIPEMIC AGENTS
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
The reproductive effects of the serum lipid-lowering agent, gemfibrozil, have been studied in rats and rabbits. In male and female rats, gemfibrozil was tumorigenic (benign liver nodules, liver carcinoma, and benign Leydig cell tumors) at 0.2 and 1.3 times the human exposure (based on AUC) (1). Treatment of female rats before and during gestation with 0.6 and 2 times the human dose (based on surface area) produced dose-related decreases in the conception rate, birth weight, and pup growth during lactation, and increased skeletal variations (1). Anophthalmia was observed rarely. The highest dose also resulted in an increased rate of stillbirths. Pregnant rabbits given 1 and 3 times the human dose during organogenesis had a decreased litter size and, at the highest dose, an increased incidence of parietal bone variations (1). Two other studies have found no evidence of reproductive or teratogenic effects in rats and rabbits (2,3).
A 1992 report described the use of gemfibrozil starting at 20 weeks' gestation in a 33-year-old woman with eruptive xanthomas (4). The patient had a similar condition in her first pregnancy that included hypertriglyceridemia, fulminant pancreatitis, and acute respiratory distress syndrome (4). A dose of 600 mg 4 times daily for 2 months lowered the triglyceride level from 7530 to 4575 mg/dL, and the total cholesterol level from 1515 to 1325 mg/dL, but the xanthomas persisted throughout her pregnancy. A healthy, term infant (birth weight and sex not specified) was eventually delivered.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 8 newborns had been exposed to gemfibrozil during the 1st trimester and 7 in the 2nd or 3rd trimesters (5). One defect, a structural brain anomaly, was observed in an infant delivered from a mother who took the agent after the 1st trimester. In a separate case included in this report, an infant with Pierre Robin syndrome, suspected of being associated with 1st-trimester exposure to gemfibrozil, was reported retrospectively to the FDA (5).
Breast Feeding Summary
No reports describing the use of gemfibrozil during lactation have been located. The relatively low molecular weight (about 250) probably indicates that the drug will be excreted into milk. Gemfibrozil should probably not be used in breast feeding women because of the potential for severe toxicity, including tumors, in the nursing infant.
References
- Product information. Lopid. Parke-Davis, 2000.
- Kurtz SM, Fitzgerald JE, Fisken RA, Schardein JL, Reutner TF, Lucas JA. Toxicological studies on gemfibrozil. Proc R Soc Med 1976;69(Suppl 2):1523. As cited in Schardein JL. Chemically Induced Birth Defects. 2nd ed. New York, NY:Marcel Dekker, 1993:81.
- Fitzgerald JE, Petrere JA, De La Iglesia FA. Experimental studies on reproduction with the lipid-regulating agent gemfibrozil. Fund Appl Toxicol 1987;8:45464. As cited in Shepard TH. Catalog of Teratogenic Agents. 7th ed. Baltimore, MD:Johns Hopkins University Press, 1992:188.
- Jaber PW, Wilson BB, Johns DW, Cooper PH, Ferguson JE II. Eruptive xanthomas during pregnancy. J Am Acad Dermatol 1992;27:3002.
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Rosa F. Anti-cholesterol agent pregnancy exposure outcomes. Presented at the 7th International Organization for Teratogen Information Services, Woods Hole, MA, April 1994.
Questions and Answers
So its okay to take simvastatin and gemfibrozil together as long as we have our blood monitored? ?, Please get back to me asap. My husband is on both of them as we speak.
Yes, it is done all the time.
Simvastatin (brand name Zocor) is a "statin" drug. It inhibits the HMG-Co A reductase pathway, which is responsible for making cholesterol in the body. Its main effect is lowering LDL (low density lipoprotein) or so called "bad cholesterol". Statins have also been shown to stop the progression of and stabilize arterial plaques (atherosclerosis).
Gemfibrozil (brand name Lopid) is a "fibrate". Its main effect is lowering the Triglyceride levels. It also modestly increases HDL (high density lipoprotein) or so called "good cholesterol". but has very little effect on LDL.
They are both metabolized by the liver. Taking them together can lead to a higher chance of having side effects (muscle cramping, muscle pain, etc) so you have to be careful. Blood tests are also done to monitor liver health.
Why can't I drink beer when I take the drug Gemfibrozil?, I drink beer all of the time. I would experiment to see if it affected me weirdly.
From their website..
Alcohol
Gemfibrozil may cause dizziness or blurred vision.6 Alcohol may intensify these effects, increasing the risk for accidental injury. People taking gemfibrozil should avoid alcohol.
If I start taking Lopid (Gemfibrozil) for a tri level of 270, will I have to stay on it for life?,
Gemfibrozil controls high cholesterol and triglycerides but does not cure them. Continue to take gemfibrozil even if you feel well. Do not stop taking gemfibrozil without talking to your doctor.
What are syptoms of withdrawal from lopdis (gemfibrozil) ?,
Here is the best place to find out that info
http://www.pdrhealth.com/home/home.aspx
I have had high triglicides in my chlorestral and I take Gemfibrozil medication 600mg in am and again @ in pm.?, Does any know of any remedy other then cooked oatmeal to bring it down? I have had this for 3 years. Please open for suggestion.
Important things to do: eat a healthy diet (low in fat is always good with high cholesterol), adequate amounts of moderate intensity exercise, and weight loss.
And just throwing another idea out there, you can try Cheerios. It's 100% whole grain oats, and there's tons of advertising for it! Good luck!
should you take pravochol lovestatin and gemfibrozil together?, Taking three of these meds scares me interactions between statins and gemfibozil are noted does any one know about this?
Either pravachol(pravastatin) or lovastatin plus gemfibrozil are fine, there is no reason to take 2 statin medications together and that will increase the side effects without really helping effectiveness, talk to your doctor about why they have you on 2 medications in that class and ask about which one you should take and which one you should stop, so you will end up probly keeping the gemfibrozil and one of the other 2 not both
I take Gemfibrozil, it burns my esophagus causing great pain and discomfort.. any suggestions I'd appreciate., I take 2 600 Mg Gemfibrozil to reduce Triglycerides. It festers in my esophagus, causing my sinus to flow, and I often throw up whatever else I've drunk or eaten with it.. instructions disallow me to cut them in half... I tell my Physician and he just looks at me like I'm nuts..
Click on this link, it will help you
http://www.webmd.com/drugs/index-drugs.a...
Husband has daily mouth pain, meds taken include Lisinopril, Aciphex & Gemfibrozil. Could these cause the pai?, His dentist can find no reason for the mouth pain. He states that it hurts somewhere different each day and sometimes burns. No sores, no redness, etc, just pain.
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Drug interactions : Simvastatin and Gemfibrozil. Can they be taken together?, According to drugdigest.org :
"SIMVASTATIN may interact with GEMFIBROZIL (in Gemfibrozil Tablets)
Although the cause of this potential interaction is not clearly understood, using gemfibrozil and simvastatin at the same time could cause a serious or potentially life-threatening side effect that involves the destruction of muscle tissue and could lead to kidney failure. These drugs should generally not be used together unless your doctor is monitoring you closely."
My question is :
What does "together" exactly mean when we speak about drug interactions? Does this mean that I should not take Gemfibrozil for the whole period I am on Simvastatine? Or it means they can be taken with an interval of say 5-6 hours, e.g. one taken in lunchtime and the other after dinner?
For those who might refer me to a phisicist I should say I have received totally opposing advices and I am already confused!
The occurrence of rhabdomyolysis (a very rare condition of muscle deterioration that can lead to kidney failure. Rhabdomyolysis has been associated with certain statin drugs), is one of the rare side-effects of the cholesterol-lowering agent simvastatin. During the use of lovastatin, an agent related to simvastatin, the risk of this side-effect might be increased when cyclosporin or gemfibrozil are used concomitantly. It is possible that this also applies for simvastatin.
IF your doctor is monitoring you with frequent blood tests, you will be ok, but if you are going to take these drugs WITHOUT the direction and supervision of your doctor, then I would not take them together, even during intervals.
what r the side effects of Gemfibrozil?,
the common and concerning ones are elevated liver enzymes and rhabdomyolysis (muscle damage), risks increase when one is using statins, good luck
