The FDA also updated the label for Ampyra, which is approved to help MS patients walk, to warn about the need to check kidney function before people start taking it, and every year after that.
(Reporting by Anna Yukhananov; Editing by Maureen Bavdek)
The U.N. health agency is urging governments and doctors to step up surveillance of antibiotic-resistant gonorrhea, a bacterial infection that can cause inflammation, infertility, pregnancy complications and, in extreme cases, lead to maternal death. Babies born to mothers with gonorrhea have a 50 percent chance of developing eye infections that can result in blindness.
"This organism has basically been developing resistance against every medication we've thrown at it," said Dr. Manjula Lusti-Narasimhan, a scientist in the agency's department of sexually transmitted diseases. This includes a group of antibiotics called cephalosporins currently considered the last line of treatment.
"In a couple of years it will have become resistant to every treatment option we have available now," she told The Associated Press in an interview ahead of WHO's public announcement on its 'global action plan' to combat the disease.
Lusti-Narasimhan said the new guidance is aimed at ending complacency about gonorrhea and encouraging researchers to speed up their hunt for a new cure.
Once considered a scourge of sailors and soldiers, gonorrhea
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The U.N. health agency is urging governments and doctors to step up surveillance of antibiotic-resistant gonorrhea, a bacterial infection that can cause inflammation, infertility, pregnancy complications and, in extreme cases, lead to maternal death. Babies born to mothers with gonorrhea have a 50 percent chance of developing eye infections that can result in blindness.
"This organism has basically been developing resistance against every medication we've thrown at it," said Dr. Manjula Lusti-Narasimhan, a scientist in the agency's department of sexually transmitted diseases. This includes a group of antibiotics called cephalosporins currently considered the last line of treatment.
"In a couple of years it will have become resistant to every treatment option we have available now," she told The Associated Press in an interview ahead of WHO's public announcement on its 'global action plan' to combat the disease.
Lusti-Narasimhan said the new guidance is aimed at ending complacency about gonorrhea and encouraging researchers to speed up their hunt for a new cure.
Once considered a scourge of sailors and soldiers, gonorrhea
View the Original article
Drug-resistant gonorrhoea on the …
The World Health Organization warned on Wednesday of a spreading resistance to drugs used to treat the sexually transmitted disease gonorrhoea.Millions of people with the condition may be at risk of running out of treatment options unless urgent action is taken, the United Nations agency said.
Several countries, including Australia, Britain, France, Japan, Norway, and Sweden have reported cases of resistance to cephalosporin antibiotics -- the last treatment option against gonorrhoea, which affects an estimated 106 million people.
The WHO has called for greater vigilance on the correct use of antibiotics and more research into alternative treatments.
Resistance can be caused by the overuse and poor quality of antibiotics.
"We are very concerned," said Manjula Lusti-Narasimhan, from the WHO's reproductive health unit, "as there are no new therapeutic drugs in development."
"If gonococcal infections become untreatable, the health implications are significant."
Untreated gonorrhoea can cause infertility in both men and women.
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Adderall is also used to treat narcolepsy. The drug, made by Teva Pharmaceutical Industries, is currently in short supply in the United States.
The counterfeit versions of Adderall are ineffective and potentially harmful, the FDA warned Tuesday.
Authentic Adderall contains four active ingredients: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Preliminary laboratory tests by the FDA found that the counterfeit version being sold as Adderall 30-milligram (mg) tablets contains tramadol and acetaminophen, ingredients in medicines used to treat acute pain.
Genuine Adderall 30-mg tablets are round, orange/peach in color, and have "dp" embossed on one side and "30" on the other side. The tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02, the agency said.
In contrast, the counterfeit tablets are round, white and do not have any type of letters or numbers, the FDA said. Fake tablets may also come in blister packages and have spelling mistakes on the packaging, such as:
"NDS" instead of "NDC""Aspartrte" instead of "Aspartate""Singel" instead of "Single."Consumers who believe they have the counterfeit version of 30-mg Adderall tablets should not use them and should talk to their health care professional about their treatment options, the FDA said.
Adderall is currently in short supply because Teva is having difficulty obtaining all of the active ingredients used in the drug. Consumers need to be extra cautious when buying medicines online and remember that drugs in short supply are often targets for counterfeiting, the FDA said.
More information
The U.S. Food and Drug Administration offers a consumer safety guide for buying prescription medicines online.
The FDA says the product purports to be 30-milligram Adderall tablets, but it does not contain the right ingredients. The pills contain the pain drugs tramadol and acetaminophen instead. The agency says the counterfeit tablets are white and round, and they do not have any markings like letters or numbers. Genuine Adderall tablets are an orange/peach color and have the letters "dp" embossed on one side with the number 30 on the opposite side.
Adderall is made by Teva Pharmaceutical Industries Ltd., and it is used to treat ADHD and narcolepsy. The drug is in short supply because of shortages of the active ingredients.
The Food and Drug Administration on Thursday said at least two people had died from the procedure, which uses stents or balloon angioplasties to widen veins that connect the brain and spinal cord to the heart. One person was permanently paralyzed, and others had bleeding in the brain, suffered strokes, blood clots or other side effects.
It is unknown how many people received the treatment and how many had problems, as stents and angioplasties are not approved for this use by the FDA, the agency said. Stents are steel mesh coils that can keep arteries open, while balloon angioplasties use a balloon at the tip of a catheter to open blocked blood vessels.
The FDA could not immediately identify the stent models being used in such treatments.
The FDA announcement relates to a controversy that has developed in the multiple sclerosis (MS) community about the causes of the chronic, progressive disorder of the brain and spinal cord.
The disease, which affects about 2.5 million people worldwide and has no cure, attacks the central nervous system and can lead to numbness, paralysis and loss of vision. Drugs that treat the condition, from companies like Biogen Idec Inc and Sanofi SA, can often only prevent relapses or slow its progression.
The underlying cause of MS is unknown. Some researchers believe that although it is typically thought of as a disorder of the immune system, it may actually be caused by blood vessel changes. Their theory is that veins bringing blood from the brain and spine back to the heart sometimes become too narrow, making blood leak back into the brain tissue. They say that could trigger inflammation, eventually causing the balance and muscle problems seen in MS.
Other scientists have not been able to show a link between MS and compromised blood flow, which is called chronic cerebrospinal venous insufficiency, or CCSVI, or prove the condition exists at all.
Meanwhile, MS patients seek new treatments, prompting patient advocacy and research groups to invest in more research studying the link between multiple sclerosis and CCSVI.
"Our position is that the evidence is simply insufficient to determine whether there's a link," said Dr. William Maisel, deputy director and chief scientist of the FDA's devices division. "We want patients to be aware this treatment (with stents or balloon angioplasty) is unproven, that there are significant risks associated with the treatment, (and) the benefits are uncertain."
The FDA said people who want to try the experimental treatment should first discuss the risks with their doctor, or should try the treatment while participating in clinical trials.
(Reporting by Anna Yukhananov; Editing by Michele Gershberg, Maureen Bavdek and John Wallace)
The Orf virus - sometimes misdiagnosed as a more serious disease such as anthrax - is most commonly transmitted to humans on farms. It has also been reported in children who visited petting zoos and livestock fairs, the Centers for Disease Control and Prevention said.
But the CDC said people could also contract Orf by preparing infected sheep or goat meat for household use or when slaughtering the animals, and detailed four such cases in the report.
"In ethnically diverse communities, health-care providers might be unaware of patients having this type of animal contact and of the seasonal increases in contact associated with religious events," the report said.
"The popularity of hobby farming and home butchering also increases opportunities for household Orf exposures."
The report said that in 2010, a 42-year old man in Massachusetts assisted in a lamb sacrifice for the Muslim feast holiday Eid al-Adha, holding the animal's head with his left hand. Five days later, a small lesion appeared on one of the fingers of his left hand.
In another case, a 35-year-old man of Ethiopian descent cut his left thumb with a knife while slaughtering a lamb as part of Easter festivities and later suffered a thumb lesion.
Orf lesions often heal within a few weeks, CDC veterinarian Danielle Tack told Reuters. Doctors, particularly in urban areas, can sometimes misdiagnose Orf, she said.
(Editing By Cynthia Johnston and Eric Walsh)
The Merck Pharmaceutical Company …
Two Merck drugs for treating male baldness and enlarged prostate will now carry extended labels to add more possible sexual side effects, US regulators said.The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs' approval, the US Food and Drug Administration said Friday.
The new Propecia label will include "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said. Propecia is a drug to treat male baldness.
Proscar, which treats symptoms of enlarged prostate, will now have a label that adds "decreased libido that continued after discontinuation of the drug."
In addition, both labels are being revised to "include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation," the FDA said.
FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.
The latest labeling change "expands the list of sexual adverse events reported to the FDA postmarketing," she told AFP, adding that "no new clinical studies were reviewed to evaluate these adverse events."
Proscar was approved for the US market in 1992 and Propecia in 1997. In 2011, both drugs' labels were "revised to include erectile dysfunction that continued after drug discontinuation," the FDA said.
Last year, labels for Proscar and Propecia were also changed to advise of the possibility of an increased risk of high-grade prostate cancer.
The agency noted that even though "clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs."
Since these side effects may be important to some patients, doctors were urged to discuss them with patients when deciding on treatment options.
In the case of Propecia, clinical trials showed 3.8 percent of men had reported one or more adverse sexual experiences, compared to 2.1 percent who were taking a placebo.
"Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling," Merck said in a statement.
The company added that "a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established," and expressed support for ongoing monitoring of adverse event reports.
ksh/mk
The Merck Pharmaceutical Company …
Two Merck drugs for treating male baldness and enlarged prostate will now carry extended labels to add more possible sexual side effects, US regulators said.The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs' approval, the US Food and Drug Administration said Friday.
The new Propecia label will include "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said. Propecia is a drug to treat male baldness.
Proscar, which treats symptoms of enlarged prostate, will now have a label that adds "decreased libido that continued after discontinuation of the drug."
In addition, both labels are being revised to "include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation," the FDA said.
FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.
The latest labeling change "expands the list of sexual adverse events reported to the FDA postmarketing," she told AFP, adding that "no new clinical studies were reviewed to evaluate these adverse events."
Proscar was approved for the US market in 1992 and Propecia in 1997. In 2011, both drugs' labels were "revised to include erectile dysfunction that continued after drug discontinuation," the FDA said.
Last year, labels for Proscar and Propecia were also changed to advise of the possibility of an increased risk of high-grade prostate cancer.
The agency noted that even though "clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs."
Since these side effects may be important to some patients, doctors were urged to discuss them with patients when deciding on treatment options.
In the case of Propecia, clinical trials showed 3.8 percent of men had reported one or more adverse sexual experiences, compared to 2.1 percent who were taking a placebo.
"Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling," Merck said in a statement.
The company added that "a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established," and expressed support for ongoing monitoring of adverse event reports.
ksh/mk
