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More Warnings Needed on Reglan Side Effects

More Warnings Needed on Reglan Side Effects (cont.)

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by Evelyn Pringle
May 27, 2010

Devastating Disorder
Tardive dyskinesia is one of the most devastating of all drug-induced movement disorders, according to Dr Peter Breggin, author of about twenty books, including "Medication Madness."

"The abnormal movements or spasms can strike any of the muscles that are under voluntary control, including muscles of the face, eyes, mouth, tongue, neck, shoulders, arms, legs, hands, and feet," he says. "Breathing, speaking, and swallowing can also be impaired."

"Tardive dyskinesia often looks so "strange" or "bizarre" that it is mistaken for a mental illness rather than a neurological disorder," he notes.

Reglan can also cause uncontrolled muscle spasms (dystonia), Neuroleptic Malignant Syndrome, Parkinsonism, depression, thoughts of suicide, and suicide. Common side effects include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion, and trouble sleeping, according to a June 9, 2009, FDA approved medication guide.

Pregnant Women Targeted
Four months after the black box for TD was announced, a New England Journal of Medicine study claimed that Reglan was safe for pregnant women with morning sickness.

The news of the study was sent out to all the media outlets and a massive off-label marketing campaign followed to promote the sale of Reglan to pregnant women, with journalists publishing almost identical talking points.

Reporter, Linda Johnson, put out articles through the Associated Press newswire which resulted in headlines such as, "Study Suggests Drug Is Safe For Morning Sickness,"  popping up all over the internet and for major media stories for a couple weeks.

For instance, in a June 10, 2009, article that appeared in USA Today, on Fox and ABC news Websites, and even in the UK's Guardian on June 12, 2009, Johnson wrote: "For the first time, a large study shows that pregnant women who suffer morning sickness are not risking harm to their babies if they take a certain anti-nausea drug."

"The result may lead more doctors to prescribe the drug metoclopramide and women to feel less guilty about using it during their baby's crucial first few months of development, experts said," she reported. Johnson never mentioned the black box for TD in her articles.

The June 10, headline for the same article on the MSNBC Website read:  "Morning sickness drug shown safe for babies." On June 11, a Johnson article appeared in the Boston Globe and the same story was in the Durango Herald News as late as June 22.

To begin with, running headlines claiming that Reglan is safe based on the NEJM study was misleading and irresponsible because the majority of women, 2,502 out of 3,458, only took Reglan for 7 days, or less, in the first trimester. The average duration of fetal exposure was about a week. Only 164 took the drug for 22 days or more.  Plus, the study only looked at harm at birth with no later follow-up on the babies.

There was no mention in the actual study of the black box for TD, or any other adverse effects, that could harm the mom or the fetus. Yet, the Los Angeles Times ran a June 10, story with claims that the "first study of the anti-nausea drug metoclopramide in pregnant women has found that it is safe for both fetuses and mothers."  The Times failed to mention any side effects but included the main talking point that as "many as 80% of pregnant women suffer morning sickness in the first trimester."

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