FDA says Tessalon liquid cough capsules pose risk for young children

The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”

A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.

Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.

The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

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Upcoming FDA Hearing on Abuse of Cough and Cold Medications Misses the Mark

/PRNewswire/ -- The Center for Medicine in the Public Interest released the results of a national Teen Substance Abuse survey today, indicating that police officers and high school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers. These survey results come as the Food and Drug Administration has scheduled an Advisory Committee meeting for September 14 to examine whether abuse of cough and cold medications by teens requires stricter controls on the sale of those commonly used products.

Police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly sold cough and cold medicines. However, an FDA Advisory Committee next week could decide to make more than 100 brand name, over-the-counter cold and cough medicines containing the ingredient dextromethorphan available only through a doctor's prescription or place them behind the counter at pharmacies, forcing customers to receive assistance from a pharmacist or store employee to get the medicines.

When asked which substances pose the greatest negative impact on teens, teachers and police overwhelmingly identified marijuana and alcohol, followed by methamphetamine and cocaine. Additionally, no police and only 1% of high school teachers cited cough and cold medicines as having the greatest negative impact on teens.

When you think of substance abuse,
   which substances do you see as
   having the greatest negative impact
   on teens?                           Police      H.S. Teachers
  ------------------------------------ ------      -------------
  Alcohol//beer                                51%              70%
  -------------                               ---              ---
  Marijuana//pot                               69%              51%
  Prescription drugs//prescription
   pills                                       27%              15%
  --------------------------------            ---              ---
  Methamphetamine//crystal
   methamphetamine                             28%               9%
  Cocaine//coke//crack                         22%               8%
  --------------------                        ---              ---
  Heroin                                       12%               3%
  Ecstasy                                       6%               5%
  -------                                     ---              ---
  Cigarettes//tobacco                           3%               6%
  Inhalants//spray can fumes                    3%               -
  --------------------------                  ---              ---
  Over the counter medicine//non
   prescription medication                      1%               2%
  Cough//Medicines//Cold
   Medicines//DXM                               -                1%

CMPI's study also shows that alcohol, marijuana, prescription drugs, methamphetamine, cocaine and cigarettes are cited among the top substances posing the most serious problems to teens:

% Selecting as Most/2(nd) Most/
   3(rd) Most Serious Problem
   Substance                          Police      H.S. Teachers
  ----------------------------------- ------      -------------
  Alcohol                                     82%              88%
  -------                                    ---              ---
  Pot                                         76%              75%
  ---                                        ---              ---
  Prescription drugs                          41%              27%
  ------------------                         ---              ---
  Meth                                        32%              22%
  ----                                       ---              ---
  Cigarettes                                  14%              36%
  ----------                                 ---              ---
  Cocaine/Crack                               27%              15%
  -------------                              ---              ---
  Ecstasy                                      5%               9%
  -------                                    ---              ---
  OTC cough and cold medicine                  5%               8%

The survey also reveals that by a margin of two to one, police officers and high school teachers support education efforts as a means to address abuse of over-the-counter cough and cold medicines, versus restricted accessibility to consumers.

"Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store," says CMPI Vice President Robert Goldberg, Ph.D. "Overly restricting access to cough and cold products containing dextromethorphan will create more health problems than it will solve, especially during cold and flu seasons. We need to find common sense solutions and invest more resources in education."

The entire Teen Substance Abuse survey is available at www.cmpi.org and the poll was conducted by Fabrizio Ward and Associates.

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