And they Didn't Feel the Need to Warn Patients
By John Lauerman
Oct. 4 (Bloomberg) -- GlaxoSmithKline Plc, the world's second biggest drugmaker, recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients.
Glaxo doesn't know how many of the 7.5 million recalled pills were missing paroxetine hydrochloride, or how many patients took the pills, spokesman Michael Fleming said in a telephone interview today. The company didn't tell patients because tests on a later lot of about the same size suggested as few as one pill may have lacked the ingredient, Fleming said.
Doctors said the lack of a warning could mean that patients may face a sudden withdrawal that can spur suicidal thoughts, shooting pain and flu-like symptoms. The Paxil CR pills Glaxo recalled, the highest dose sold, can cause severe withdrawal symptoms, said Stephen Ellen of the University of Massachusetts Medical School in Worcester.
``If it is true that patients might have gotten dummy pills without knowing it, it is outrageous,'' said Ellen, a psychiatrist who is medical director of the Counseling Center of Nashua in New Hampshire, the largest private psychiatric group practice in New England with about 6,000 patients annually.
About 280,000 Americans take Paxil CR, a long-acting version of another Glaxo antidepressant that has lost patent protection, Fleming said. About 14 percent of those patients take the 37.5 milligram pill that was recalled, he said.
Flawed Drugs
Peter Lurie, deputy director of the health research group at Public Citizen, a Washington-based advocacy group, said drugmakers can limit the number of returned products in a recall by not advising patients.
``To the extent patients learn of it, they're likely to return distributed inventory and that's going to cost the company money,'' Lurie said in a telephone interview today. ``This way the company gets to say they did a recall, they dump the responsibility on intermediaries, and the patient most likely hears nothing.''
Fleming said Glaxo restricted its actions, with U.S. Food and Drug Administration approval, because the drugmaker wanted to minimize disruptions in treatment and avoid alarming patients. He said London-based Glaxo voluntarily advised U.S. regulators and some doctors about the possibility of inactive pills in September.
Ellen, though, said he wasn't notified, adding, ``I would have remembered something like that.''
``The real horror is that people might continue to take dummy pills without realizing it,'' he said in a telephone interview yesterday.
FDA Response
FDA spokeswoman Susan Cruzan said she didn't know the details of the September Paxil CR recall.
The FDA didn't require its highest level of recall, Class 1, when drugs posing a serious health hazard have entered the marketplace and consumers are able to take action. In those cases, the agency might require patients be informed, she said.
Last year, the FDA seized some lots of Paxil CR after it was discovered that the pills, made at a company plant in Cidra, Puerto Rico, sometimes split inappropriately. Glaxo recalled all batches of Paxil CR made before November 2004 at the time, and agreed to an independent quality review of the plant.
Production at the plant was disrupted from February through June, 2005. The issues at the Cidra plant also affected Glaxo's Avandamet diabetes drug, which is made there. The company has since hired a third-party firm to review quality measures at the Cidra plant, Fleming said.
Detection System
Glaxo has a process in place that allows it to detect pills that may accidentally have been made without all the ingredients, Fleming said. In August, the company found that an inactive pill had made it through that process without detection, he said.
The company determined the same flaw may have affected the March lot, the last one made before August. Glaxo then decided to recall that lot from all pharmacists and wholesalers, Fleming said. The company didn't advise patients then because only one bad pill was found when Glaxo did testing on the previous lot, Fleming said.
``It was an equipment-related issue,'' he said. ``We don't believe it poses a health risk to patients.''
Medco Health Solutions Inc., the largest U.S. manager of drug benefits for companies and insurers, said it informed patients about the recall in a letter in September. Franklin Lakes, New Jersey-based Medco said in the letter it would replace Paxil CR with other drugs until Glaxo's recall is over, and more drug becomes available.
Medco
Medco ``decided that it was prudent to simply inform patients of the situation and ask them to consult their health- care provider,'' spokeswoman Ann Smith said in an e-mailed statement today. ``We specifically told the patient not to stop taking their medication.''
Antidepressants such as Paxil CR, called selective serotonin reuptake inhibitors or SSRIs, sustain levels of serotonin, a chemical found naturally in the body that helps stabilize moods and emotions.
When patients reduce their antidepressants or stop taking the drug, cells react quickly to the lower-than accustomed dose of serotonin. Some patients have diarrhea, nausea, vomiting, chills and dizziness. Discontinuation syndrome can last until the patient's next active dose, or as long as two months if the patient completely stops using the drug.
Missed Doses
Missed doses of Paxil CR are particularly likely to cause the syndrome because the drug remains in the body for a relatively short time compared with some other antidepressants, such as Forest Laboratories Inc.'s Lexapro, Ellen said.
Paxil CR also slows nerve cells' production of proteins, called receptors, which interact with a mood-affecting chemical called serotonin, he said.
The strength of Paxil CR, the high dose that the pills normally give, and the reduction of serotonin receptors is a ``nasty combination,'' Ellen said.
Glaxo changed Paxil's label to say that stopping the drug might lead to ``discontinuation syndrome.'' The change came after a California lawsuit charged the company with failing to warn the public about the danger of withdrawal.
Glaxo shares rose 2 pence to close at 1459 pence in London today. The shares have gained less than 1 percent in the past 12 months.
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net .
http://www.bloomberg.com/apps/news?pid=20601102&sid=aA2ceUDWD1QM&refer=uk
Oct. 4 (Bloomberg) -- GlaxoSmithKline Plc, the world's second biggest drugmaker, recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients.
Glaxo doesn't know how many of the 7.5 million recalled pills were missing paroxetine hydrochloride, or how many patients took the pills, spokesman Michael Fleming said in a telephone interview today. The company didn't tell patients because tests on a later lot of about the same size suggested as few as one pill may have lacked the ingredient, Fleming said.
Doctors said the lack of a warning could mean that patients may face a sudden withdrawal that can spur suicidal thoughts, shooting pain and flu-like symptoms. The Paxil CR pills Glaxo recalled, the highest dose sold, can cause severe withdrawal symptoms, said Stephen Ellen of the University of Massachusetts Medical School in Worcester.
``If it is true that patients might have gotten dummy pills without knowing it, it is outrageous,'' said Ellen, a psychiatrist who is medical director of the Counseling Center of Nashua in New Hampshire, the largest private psychiatric group practice in New England with about 6,000 patients annually.
About 280,000 Americans take Paxil CR, a long-acting version of another Glaxo antidepressant that has lost patent protection, Fleming said. About 14 percent of those patients take the 37.5 milligram pill that was recalled, he said.
Flawed Drugs
Peter Lurie, deputy director of the health research group at Public Citizen, a Washington-based advocacy group, said drugmakers can limit the number of returned products in a recall by not advising patients.
``To the extent patients learn of it, they're likely to return distributed inventory and that's going to cost the company money,'' Lurie said in a telephone interview today. ``This way the company gets to say they did a recall, they dump the responsibility on intermediaries, and the patient most likely hears nothing.''
Fleming said Glaxo restricted its actions, with U.S. Food and Drug Administration approval, because the drugmaker wanted to minimize disruptions in treatment and avoid alarming patients. He said London-based Glaxo voluntarily advised U.S. regulators and some doctors about the possibility of inactive pills in September.
Ellen, though, said he wasn't notified, adding, ``I would have remembered something like that.''
``The real horror is that people might continue to take dummy pills without realizing it,'' he said in a telephone interview yesterday.
FDA Response
FDA spokeswoman Susan Cruzan said she didn't know the details of the September Paxil CR recall.
The FDA didn't require its highest level of recall, Class 1, when drugs posing a serious health hazard have entered the marketplace and consumers are able to take action. In those cases, the agency might require patients be informed, she said.
Last year, the FDA seized some lots of Paxil CR after it was discovered that the pills, made at a company plant in Cidra, Puerto Rico, sometimes split inappropriately. Glaxo recalled all batches of Paxil CR made before November 2004 at the time, and agreed to an independent quality review of the plant.
Production at the plant was disrupted from February through June, 2005. The issues at the Cidra plant also affected Glaxo's Avandamet diabetes drug, which is made there. The company has since hired a third-party firm to review quality measures at the Cidra plant, Fleming said.
Detection System
Glaxo has a process in place that allows it to detect pills that may accidentally have been made without all the ingredients, Fleming said. In August, the company found that an inactive pill had made it through that process without detection, he said.
The company determined the same flaw may have affected the March lot, the last one made before August. Glaxo then decided to recall that lot from all pharmacists and wholesalers, Fleming said. The company didn't advise patients then because only one bad pill was found when Glaxo did testing on the previous lot, Fleming said.
``It was an equipment-related issue,'' he said. ``We don't believe it poses a health risk to patients.''
Medco Health Solutions Inc., the largest U.S. manager of drug benefits for companies and insurers, said it informed patients about the recall in a letter in September. Franklin Lakes, New Jersey-based Medco said in the letter it would replace Paxil CR with other drugs until Glaxo's recall is over, and more drug becomes available.
Medco
Medco ``decided that it was prudent to simply inform patients of the situation and ask them to consult their health- care provider,'' spokeswoman Ann Smith said in an e-mailed statement today. ``We specifically told the patient not to stop taking their medication.''
Antidepressants such as Paxil CR, called selective serotonin reuptake inhibitors or SSRIs, sustain levels of serotonin, a chemical found naturally in the body that helps stabilize moods and emotions.
When patients reduce their antidepressants or stop taking the drug, cells react quickly to the lower-than accustomed dose of serotonin. Some patients have diarrhea, nausea, vomiting, chills and dizziness. Discontinuation syndrome can last until the patient's next active dose, or as long as two months if the patient completely stops using the drug.
Missed Doses
Missed doses of Paxil CR are particularly likely to cause the syndrome because the drug remains in the body for a relatively short time compared with some other antidepressants, such as Forest Laboratories Inc.'s Lexapro, Ellen said.
Paxil CR also slows nerve cells' production of proteins, called receptors, which interact with a mood-affecting chemical called serotonin, he said.
The strength of Paxil CR, the high dose that the pills normally give, and the reduction of serotonin receptors is a ``nasty combination,'' Ellen said.
Glaxo changed Paxil's label to say that stopping the drug might lead to ``discontinuation syndrome.'' The change came after a California lawsuit charged the company with failing to warn the public about the danger of withdrawal.
Glaxo shares rose 2 pence to close at 1459 pence in London today. The shares have gained less than 1 percent in the past 12 months.
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net .
http://www.bloomberg.com/apps/news?pid=20601102&sid=aA2ceUDWD1QM&refer=uk
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