http://www.yourlawyer.com/topics/overview/cleocin Sat, 21 Nov 2009 16:19:53 -0800 pixel-app en http://www.yourlawyer.com/articles/read/12054 Fri, 11 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12054
Local officials have been ordered to file daily reports on possible new victims, said Jiang Zuojun. State media reports have said dozens of patients developed severe adverse reactions after receiving the drug, such as chest, kidney or stomach pains, vomiting and anaphylactic shock.

"We can't tell what was wrong with the drug at present," Jiang said at a news conference.

The government banned all sales of clindamycin phosphate glucose manufactured by Anhui Huayuan Worldbest Biology Pharmacy Co. last week after a 6-year-old girl died and dozens of people fell ill. The company says it has recalled 760,000 bottles of the drug.

Five more fatalities have been reported since then, and news reports say there is a possible seventh death.

Investigators have conducted tests on 10 aspects of the drug and nine have found nothing wrong, while the final test on possible bacteria in the drug hasn't been completed, according to Jiang. The final test results won't be ready for another ten days or so, he said.

"If all the tests come back fine then we will have to continue and find other possible reasons for the problem we are now facing," Jiang said.

He said there was no plan to ban all clindamycin phosphate glucose including those manufactured by other companies since all reports of bad reactions to the drug had so far been linked to Anhui Huayuan.

China's pharmaceutical industry is highly lucrative but spottily regulated, enticing some to try to cash in by substituting fake or substandard ingredients.

In a separate case earlier this year, 11 people were killed after injecting a drug made by the Qiqihar No. 2 Pharmaceutical Co. Ltd. in the northeastern province of Heilongjiang.

An investigation showed that the drug, called Armillarisni A, contained a chemical, diglycol, that can cause kidney failure, which a vendor had passed off as a normal ingredient.]]> http://www.yourlawyer.com/articles/read/12055 Fri, 11 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12055
An SFDA spokesman said production of the "Xinfu" drug, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Co., a subsidiary of Shanghai Worldbest Co. Ltd., failed to meet required technical procedures.

An investigation team has inspected the pharmaceutical company in east China's Anhui Province and checked the procedures applied in June and July when the drug was produced.

The production records of the company were incomplete, said the spokesman, adding that investigations were continuing into the link between the patient reactions and the antibiotic injection.

The spokesman said investigations showed the company had produced 3.7 million bottles of clindamycin phosphate glucose injection since June, with more than 3.18 million bottles sold in 26 provinces across China.

More than 755,000 bottles of the drug had been recalled, 185,500 were en route back to the factory, and more than 161,200 bottles had been located and isolated in other areas, he said.

He could not account for the whereabouts of the remainder of the drug, only saying it was scattered in small hospitals, clinics and drugstores in the remote areas, where it was difficult to retrieve.

He said the drug had been removed from use as it was a prescription medicine and the Ministry of Health had banned it after reports of problems, so the situation was basically under control.

Pan Wei, vice manager in charge of production in the pharmacy company, told Xinhua that the temperature and time for disinfections during the production was not in accordance with the requirements.

The injection should be kept and transported in cool environment according to the regulation. "But we couldn't ensure that the medicines were transported under the required 20 Celsius degrees," Pan said.

At another press conference here on Thursday, Vice Minister of Health Jiang Zuojun said investigators are still waiting for the result of index for bacteria of the problematic drug.

Since the first report of the problematic injection on July 27, the drug is blamed for killing six and causing illness to at least 80 people in ten provinces including Zhejiang, Heilongjiang, Hunan and Shandong.

Severe adverse reactions were reported among patients after taking the drug, such as chest, kidney or stomach pains, vomiting and anaphylactic shock.

The Ministry of Health has demanded that all provincial health departments report cases of adverse reactions to the problematic drug by 4 p.m. each day.

Two months earlier, a fake injection produced by the Qiqihar No. 2 Pharmaceutical Co.,Ltd., a privately-owned business in northeast China's Heilongjiang Province, caused 11 deaths in China.

Both of the companies in the two accidents are qualified pharmaceutical companies and the medicines produced by the two firms were sold to market through legal channels. The fact makes Chinese public worry about the safety of medicine and supervision of the medicine market.

Zhao Xueming, head of the Association for Medical Workers in Heilongjiang, said that the two accidents show the loophole in China's drug administration.

He said China's drug administration department should strengthen supervision and law enforcement in the production, circulation and use of medicines.
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The output of clindamycin phosphate glucose, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Co, "failed to follow required technical procedures," said a spokesman for the State Food and Drug Administration (SFDA).

An investigation team which checked the procedures followed in June and July when the drug was produced found the company's production records were incomplete, said the spokesman.

He added that investigations were continuing into the link between adverse patient reactions and the injection made by the pharmaceutical company in East China's Anhui Province.

But at a news conference yesterday, Jiang Zuojun, vice-minister of health, said the "true reason behind the accident has not yet been discovered."

Of the 10 tests conducted on the drug, nine have found nothing wrong; and results of the final test on possible bacterial infection will be available only after 10 days, Jiang said.

"If all the tests come back fine, we will have to find other possible reasons for the problem we are now facing," Jiang said.

He said there is no plan for a blanket ban on the drug which is also made by other companies since all reports of adverse side effects have so far been linked to the Anhui firm.

The company produced 3.7 million injection bottles since June, with more than 3.18 million sold in 26 provinces.

More than 755,000 bottles of the drug have been recalled, 185,500 are on their way to the factory, and more than 161,200 have been sealed.

The SFDA spokesman could not account for the whereabouts of the remainder, only saying they were scattered in small hospitals, clinics and drugstores in remote areas, from where it is difficult to retrieve them.

The Anhui company began production of clindamycin phosphate glucose widely used by grassroots medical institutions to treat bacterial infections in 2001.

The Ministry of Health banned the use of the drug made by Anhui Huayuan nationwide on August 4 after reports of adverse reactions began to surface. So far more than 80 patients have developed severe reactions such as chest, kidney or stomach pains, vomiting and anaphylactic shock after receiving the drug.

The event has drawn attention to overuse of antibiotics in the country. The drug was introduced in the country in 1970s and was initially used in small doses in injections. But since the late 1990s, hospitals began to use it in large doses in drip infusions, according to Guangzhou-based 21 Century Business Herald.

"A drip infusion usually costs much more than an injection," which means more profits for pharmaceutical companies, it quoted Sun Zhongshi, a pharmacist at the National Drug Evaluation Centre at SFDA, as saying.
]]> http://www.yourlawyer.com/topics/overview/cleocin Fri, 11 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/cleocin Injured by Cleocin? Cleocin (generic: Clindamycin) is an antibiotic prescribed in the United States to treat infections of the respiratory tract, skin, pelvis, vagina, and abdomen. Cleocin is available in these forms: oral solution, capsule or injection. Recently, Cleocin has made headlines in China as seven people have died after receiving injection of the drug. Cindamycin phosphate glucose injection in China is produced by the Anhui Huayuan Worldbest Biology Pharmacy Co.

The latest victim a 76-year-old women had been injected with 4 bottles of the medicine experienced shortness of breath and vomiting. On August 4, 2006, The Health Ministry of China issued a nationwide ban on Clindamycin. Local health authorities on August 8, 2006 were instructed to start daily reports on people experiencing adverse reactions to the drug. The daily reporting system was last used as China battled the severe acute respiratory syndrome (SARS) in 2003. The ministry also ordered local departments to speed up their drive to bring the injection out of circulation, to avoid any new deaths. The Anhui Company has sold 3.18 million units of the injection to 26 provinces, regions and municipalities throughout China.

Other side effects

• Peudomembranous colitis
• Diarrhea
• Dry skin
• Reddish skin
• Skin irritation
• Skin rash
• Oiliness
• Itching
• Burning
• Vaginal inflammation
• Vaginal pain
• Vaginal infection

If you or a loved one has been prescribed the antibiotic Cleocin and you experienced serious side effects or death, please fill out the form at the right for a free case evaluation by one of our qualified defective drug attorneys.]]>