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FDA A Little Late In Protecting The Public
The Advocate
By Herb Denenberg, The Bulletin
This is another tale suggesting that if you rely on the FDA, drug companies and your doctors to give you the truth about prescription drugs, you may get the truth 10, 20, or perhaps 40 years late. In other words, the FDA protects the public; they’re just a little late in doing so.
This tale also involves one of the top selling generic drugs in the U.S., one dispensed 6.5 million times in 2008. The drug’s brand name is Reglan (generic: metoclopramide). It is approved by the FDA for heartburn after eating and during the daytime (what is called symptomatic gastroesophageal (GI) reflux) and for a GI condition in diabetics known as gastroparesis (slow stomach emptying). It is available in tablets, syrups and injections.
And here comes the punch line. In its February 1996 issue of Worst Pills, Best Pills News, the newsletter on drugs published by the Health Research Group of Public Citizen, there was a warning that this drug could cause tardive dyskinesia, a sometimes irreversible and incurable movement disorder. This may mean that for the rest of life, there may be involuntary, uncontrollable and repetitive movements of the body.
Now in its January 2010 issue, Worst Pills, Best Pills News announced the FDA is finally including a black box warning, which includes the following: “Treatment with metoclopramide [Reglan] can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and cumulative dose.
“Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may leave or resolve after metoclopramide treatment is stopped.
“Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.”
A black box warning is considered the most serious warning the FDA puts out. In addition, pharmacists are required to give every patient getting a new or refilled prescription for this drug a medication guide detailing information about the drug, including the black box warning. There are three different medication guides, one for each form the drug comes in. This column quotes from the medication guide for tablets. These guides are prepared by the drug company but approved by the FDA. If a drug has an FDA-approved medication guide, it must be given to every patient that fills a prescription for the drug.
This delayed warning of a drug’s danger is all too typical. It took 16 years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned.
Under the heading, “What You Can Do,” Worst Pills, Best Pills News advises, “If you or a family member are taking metoclopramide and have developed uncontrollable movements, contact the prescribing physician immediately.”
The newsletter also points out that those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.
I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: “It is not possible for your doctor to know if you will get TD [tardive dyskinesia].” So even short-term use may cause tardive dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.
In addition, the patient should be aware that there are many other side effects from using this medicine, and that should go into his decision making. Here is what the medication guide says about Reglan’s most serious side effects besides tardive dyskinesia:
• Depression, thoughts about suicide, and suicide … Some people who take Reglan have ended their own lives (suicide).
• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but serious condition that can happen with Reglan. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
• Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keep your balance.
• Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions. These spasms usually start with the first 2 days of treatments. These spasms happen more often in children and adults under the age 30.” Do not confuse dystonia with tardive dyskinesia. They are two different side effects, despite superficial similarities.
Some of the common side effects include feeling restless, sleepy, tired, dizzy, or exhausted; headache; confusion; and trouble sleeping.
The medication guide for Reglan is approved by the FDA, so it may have a slightly higher standard for truth telling than if it were the sole responsibility of the drug company that makes it.
Other drug critics have been critical of the drug Reglan. Graedon and Graedon in their book Best Choices from The People’s Pharmacy wrote, “Unfortunately, it also has some nasty side effects , including drowsiness, dizziness, mental depression, suicidal thoughts, confusion, fatigue, insomnia, headache, hallucinations, and involuntary muscle contractions that may be irreversible. Not surprisingly, Reglan is not one of our favorite drugs.”
The morals of this tale are many and important. Among them:
• The FDA takes years to properly publicize serious problems with drugs, so you better do some of your own research. I suggest subscribing to the website of Worst Pills, Best Pills as it gives you drug information that comes much earlier than that of the party line of the FDA and the drug companies. There is also a Worst Pills Best Pills book, which is a handy reference, if you like to get your information from books rather than the Internet. Take a look at the reference section of a good public library, and you’ll find many valuable books on drugs. An Internet search will also yield valuable information on drugs (or about anything else).
• When a drug is prescribed, ask your doctor about the side effects of the drug, especially the serious side effects, and what you should watch out for to make sure you minimize their occurrence and damage. Also ask if there are any non-drug alternatives. Of course, make sure your doctor and pharmacist know of all other prescription and over-the-counter drugs you’re taking, as well as herbs, vitamins, minerals, and nutritional supplements.
• Take advantage of all sources of information. Ask for any material the pharmacist can provide and ask for the package insert of the drug (which is the detailed information included in the Physicians’ Desk Reference).
• Be aware that it may take many years for drug’s side effects to be discovered. Reglan went on the market in 1979, and Worst Pills, Best Pills News did not sound the warning on tardive dyskinesia until 1996, and they have an excellent record of being on top of things when it comes to drugs.
• Whatever you do, don’t assume you can rely on the FDA and other regulatory agencies to protect you. From this column you will understand why I often say FDA stands for the Foot Dragging Administration, and why one of my standard mottoes has been, “Government is the number one consumer fraud.”
• Don’t assume that because the FDA puts out a special warning such as a black box warning, or takes other special measures to stop improper prescribing that doctors actually get the word. Take the case of Propulsid (generic: cisapride), another drug used for heartburn. When taken with certain drugs, it caused a life threatening heart rhythms called torsades de pointes. Graedon and Graedon report, “Because the FDA was unsuccessful at keeping physicians and pharmacists from prescribing and dispensing incompatible drugs with cisapride, the feds decided that this heartburn drug needed to be removed from the market.” That means it may be wise to read the guides and warnings yourself in case your doctor doesn’t or forgets what he read. Reinforcing your vigilance should be the evidence that improper prescribing often continues in the face of specific warnings about that very improper prescribing.
· Despite the FDA’s failures, it is still the proof of the need for government regulation. We need the FDA, but its failures have been evident for many decades, and there is no sign of a fix in our future. And the FDA’s failures also reveal the failures of the federal government and our Congress, which has the oversight function over our federal agencies. Finally, the FDA’s failures suggest that we should not expect too much out of federal intervention. It can deliver no miracles, and should be considered a last resort rather than a first resort.
Herb Denenberg has served as Pennsylvania Insurance Commissioner, Public Utility Commissioner and the Loman Professor of Insurance at the Wharton School of the University of Pennsylvania. He served on the board of the Committee for Safe Medication Use and was elected to the Institute of Medicine of the National Academy of Sciences in 1973. He has testified many times before Congress on insurance, healthcare, and other consumer issues, and has served as consultant to many government agencies on those same matters.
This tale also involves one of the top selling generic drugs in the U.S., one dispensed 6.5 million times in 2008. The drug’s brand name is Reglan (generic: metoclopramide). It is approved by the FDA for heartburn after eating and during the daytime (what is called symptomatic gastroesophageal (GI) reflux) and for a GI condition in diabetics known as gastroparesis (slow stomach emptying). It is available in tablets, syrups and injections.
And here comes the punch line. In its February 1996 issue of Worst Pills, Best Pills News, the newsletter on drugs published by the Health Research Group of Public Citizen, there was a warning that this drug could cause tardive dyskinesia, a sometimes irreversible and incurable movement disorder. This may mean that for the rest of life, there may be involuntary, uncontrollable and repetitive movements of the body.
Now in its January 2010 issue, Worst Pills, Best Pills News announced the FDA is finally including a black box warning, which includes the following: “Treatment with metoclopramide [Reglan] can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and cumulative dose.
“Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may leave or resolve after metoclopramide treatment is stopped.
“Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.”
A black box warning is considered the most serious warning the FDA puts out. In addition, pharmacists are required to give every patient getting a new or refilled prescription for this drug a medication guide detailing information about the drug, including the black box warning. There are three different medication guides, one for each form the drug comes in. This column quotes from the medication guide for tablets. These guides are prepared by the drug company but approved by the FDA. If a drug has an FDA-approved medication guide, it must be given to every patient that fills a prescription for the drug.
This delayed warning of a drug’s danger is all too typical. It took 16 years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned.
Under the heading, “What You Can Do,” Worst Pills, Best Pills News advises, “If you or a family member are taking metoclopramide and have developed uncontrollable movements, contact the prescribing physician immediately.”
The newsletter also points out that those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.
I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: “It is not possible for your doctor to know if you will get TD [tardive dyskinesia].” So even short-term use may cause tardive dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.
In addition, the patient should be aware that there are many other side effects from using this medicine, and that should go into his decision making. Here is what the medication guide says about Reglan’s most serious side effects besides tardive dyskinesia:
• Depression, thoughts about suicide, and suicide … Some people who take Reglan have ended their own lives (suicide).
• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but serious condition that can happen with Reglan. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
• Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keep your balance.
• Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia). These muscle spasms can cause abnormal movements and body positions. These spasms usually start with the first 2 days of treatments. These spasms happen more often in children and adults under the age 30.” Do not confuse dystonia with tardive dyskinesia. They are two different side effects, despite superficial similarities.
Some of the common side effects include feeling restless, sleepy, tired, dizzy, or exhausted; headache; confusion; and trouble sleeping.
The medication guide for Reglan is approved by the FDA, so it may have a slightly higher standard for truth telling than if it were the sole responsibility of the drug company that makes it.
Other drug critics have been critical of the drug Reglan. Graedon and Graedon in their book Best Choices from The People’s Pharmacy wrote, “Unfortunately, it also has some nasty side effects , including drowsiness, dizziness, mental depression, suicidal thoughts, confusion, fatigue, insomnia, headache, hallucinations, and involuntary muscle contractions that may be irreversible. Not surprisingly, Reglan is not one of our favorite drugs.”
The morals of this tale are many and important. Among them:
• The FDA takes years to properly publicize serious problems with drugs, so you better do some of your own research. I suggest subscribing to the website of Worst Pills, Best Pills as it gives you drug information that comes much earlier than that of the party line of the FDA and the drug companies. There is also a Worst Pills Best Pills book, which is a handy reference, if you like to get your information from books rather than the Internet. Take a look at the reference section of a good public library, and you’ll find many valuable books on drugs. An Internet search will also yield valuable information on drugs (or about anything else).
• When a drug is prescribed, ask your doctor about the side effects of the drug, especially the serious side effects, and what you should watch out for to make sure you minimize their occurrence and damage. Also ask if there are any non-drug alternatives. Of course, make sure your doctor and pharmacist know of all other prescription and over-the-counter drugs you’re taking, as well as herbs, vitamins, minerals, and nutritional supplements.
• Take advantage of all sources of information. Ask for any material the pharmacist can provide and ask for the package insert of the drug (which is the detailed information included in the Physicians’ Desk Reference).
• Be aware that it may take many years for drug’s side effects to be discovered. Reglan went on the market in 1979, and Worst Pills, Best Pills News did not sound the warning on tardive dyskinesia until 1996, and they have an excellent record of being on top of things when it comes to drugs.
• Whatever you do, don’t assume you can rely on the FDA and other regulatory agencies to protect you. From this column you will understand why I often say FDA stands for the Foot Dragging Administration, and why one of my standard mottoes has been, “Government is the number one consumer fraud.”
• Don’t assume that because the FDA puts out a special warning such as a black box warning, or takes other special measures to stop improper prescribing that doctors actually get the word. Take the case of Propulsid (generic: cisapride), another drug used for heartburn. When taken with certain drugs, it caused a life threatening heart rhythms called torsades de pointes. Graedon and Graedon report, “Because the FDA was unsuccessful at keeping physicians and pharmacists from prescribing and dispensing incompatible drugs with cisapride, the feds decided that this heartburn drug needed to be removed from the market.” That means it may be wise to read the guides and warnings yourself in case your doctor doesn’t or forgets what he read. Reinforcing your vigilance should be the evidence that improper prescribing often continues in the face of specific warnings about that very improper prescribing.
· Despite the FDA’s failures, it is still the proof of the need for government regulation. We need the FDA, but its failures have been evident for many decades, and there is no sign of a fix in our future. And the FDA’s failures also reveal the failures of the federal government and our Congress, which has the oversight function over our federal agencies. Finally, the FDA’s failures suggest that we should not expect too much out of federal intervention. It can deliver no miracles, and should be considered a last resort rather than a first resort.
Herb Denenberg has served as Pennsylvania Insurance Commissioner, Public Utility Commissioner and the Loman Professor of Insurance at the Wharton School of the University of Pennsylvania. He served on the board of the Committee for Safe Medication Use and was elected to the Institute of Medicine of the National Academy of Sciences in 1973. He has testified many times before Congress on insurance, healthcare, and other consumer issues, and has served as consultant to many government agencies on those same matters.
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Reglanlawyer wrote on Feb 5, 2010 12:05 PM: