A drug prescribed to millions of people for acid reflux is increasingly being linked to permanent tics, uncontrollable shaking and other serious movement problems.
Concerns about the drug have not deterred a Morrisville company from marketing a new melt-away tablet of the generic compound, metoclopramide, which helps the digestive tract contract.
Salix Pharmaceuticals won approval in September from the U.S. Food and Drug Administration for the dissolvable tablet. This spring it raised the ire of federal regulators, who said the company was downplaying the drug's side effects, notably its tendency to cause the movement disorder tardive dyskinesia, or TD.
Studies indicate that metoclopramide, which is made under various names by several drug companies in addition to Salix, is responsible for a third of TD cases. The condition is traditionally associated with old-line antipsychotic drugs such as Haldol. Last year, the FDA required that all manufacturers of the gastric drug put a prominent warning on labels to alert patients and doctors of the risk.
TD can be debilitating. August Macaluso, a former nuclear-plant maintenance manager in Charlotte, developed a permanent disability after he took metoclopramide for about three months in 2006 to quell gastric reflux.
Macaluso, 57, said he had violent shaking spells, incessant blinking, slurred speech and an exhausting restlessness.
"It was scary," said his wife, Sharon. She said she looked up his symptoms on the Internet and discovered a link to the gastric reflux drug, which her husband never took again. Doctors confirmed her suspicion after months of tests, but Macaluso has shown little improvement. He can no longer work, is on disability and is among a growing number of patients suing manufacturers.
G. Michael Freeman, associate vice president of investor relations and corporate communications for Salix, said the company's formulation of metoclopramide is new and provides an easier way to take the drug. He said no metoclopramide patients have sued Salix, which is correcting its marketing approach to satisfy regulators.
"We're working to accommodate the FDA warning," Freeman said.
In a March 19 letter, FDA authorities said Salix's promotional materials were misleading because they downplayed the dangers of the drug, putting the health warning in small type compared with claimed benefits.
"Your omission of the serious risk profile of your drug raises severe public health concerns," the letter stated.
Regulators also said Salix was misleading doctors and others that its drug was "ideal for all patients," despite explicit approval for diabetic patients who have a condition in which the stomach takes too long to empty, or certain people with gastroesophageal reflux disease, commonly called GERD.
The FDA stressed that Salix's drug should only be used for short-term therapy - no longer than 12 weeks - and only among adults who got no relief from conventional therapies that reduce acid production.
Lawyers representing Macaluso and other patients said widespread use of the drugs beyond their intended use - which is allowed if manufacturers don't market the drugs for those purposes - is compounding problems.
It's widely prescribed
An estimated 2 million people take metoclopramide, and it has been used to treat migraines, morning sickness and other problems. Edward F. Blizzard, a personal-injury lawyer in Houston, said the drug is also prescribed to children and infants.
A case reported in 2005 described TD in a 1-year-old girl given metoclopramide to curb reflux when she was 2 months old. She began having involuntary tongue movements, shaking and other symptoms.
Blizzard said the drug is often taken longer than the recommended 12 weeks because it doesn't cure the condition. Many doctors aren't aware of the required FDA warning about metoclopramide's link to TD, he said, because they often rely on a reference book that mainly contains brand-name drugs. The patents for metoclopramide have expired, and it is primarily produced by generic drugmakers that do not list their products in the doctors' drug reference.
"It's hard for physicians to find this warning," Blizzard said. "It's hard for me to find the warning, even though I know it's out there. It's a stealth warning."
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