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Lethal Drug Trade: Unsafe Medicines From Mexico

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TIMES STAFF WRITER

Medications banned or highly restricted in the United States because of severe, and sometimes fatal, side effects are being smuggled in from Mexico and peddled out of back-room shops across Southern California.

These potentially dangerous drugs, which multinational pharmaceutical companies market in Mexico, where regulations and enforcement are less stringent, have shown up consistently in more than 70 raids over the last year of markets, dress shops and swap meets catering to Latino immigrants.

Among the most common drugs seized are a banned painkiller that can cause a deadly blood disease, highly toxic antibiotics and a Mexican arthritis drug that can knock a person’s adrenal gland dangerously out of whack.

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Officials fear numerous children and adults are becoming ill, or even dying, after using the medications without anyone connecting their symptoms to the drugs. But no one is tracking the extent to which the drugs are harming people.

Some doctors say they believe the painkiller, dipyrone, has caused the deaths of at least four children in California and Texas. The cases were not part of any official reporting system, but were instead discovered through interviews with several dozen doctors, pharmacists and public health officials.

“It gives me the shivers just thinking about it,” said Gregory Thompson, an associate professor of clinical pharmacy at USC Medical School and co-leader of a Los Angeles County task force cracking down on the illegal sale of the pharmaceuticals. “Those four [cases] are just the tip of the iceberg.”

For three months, The Times followed the trail of the restricted drugs.

It begins in Mexico, where many turn to self-medication in the absence of accessible health care, yet where little is done to restrict a number of dangerous drugs. As people move north, so do the drugs. The medications most preferred by Mexican immigrants are smuggled through a porous border for sale in the back rooms of shops in Latino areas, mostly in Los Angeles and Orange counties.

This black market, despite its perils, has become for many Mexican immigrants a replica of the patchwork system they left behind.

The underground sale of Mexican-marketed pharmaceuticals sparked public outrage earlier this year when two Orange County infants died after receiving treatment in back-room clinics. Neither of the children died from drugs described in this story, but their deaths raised questions about the medications sold in the back-room pharmacies.

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“What’s most troubling is that people living here are actually putting their lives at risk by going to places where there’s not even licensed practitioners and taking drugs they don’t need that could make them sick,” said Dr. Aliza Lifshitz, a Cedars-Sinai Medical Center internist trained in Mexico.

22 Countries Ban Common Painkiller

One of the drugs, dipyrone, was taken off the U.S. market in 1977 because it can destroy the body’s ability to fight even minor infections. The drug is the most common medication found in back-room shops here. In a recent raid in Los Angeles, officials found 11 boxes of dipyrone children’s liquid, nearly 200 injections, 55 boxes of suppositories, a dozen boxes of pills and numerous cough syrups, cold medicines and vitamin shots containing the drug.

Dipyrone has been banned or withdrawn in at least 22 countries and severely restricted in nine others. Belgium requires it to be stored in a poisons cabinet and to carry a skull and crossbones label. Just weeks ago, Sweden, which had allowed the drug back on the market for three years, banned it again after it was linked to a high incidence of blood diseases.

At the same time, safe, cheap alternatives for dipyrone include aspirin, ibuprofen and Tylenol.

“It’s just a shock and it’s very disturbing,” said Dr. Philip Lee, emeritus professor at the UC San Francisco School of Medicine and a former U.S. assistant secretary of health and human services. “We’ve come a long way in the U.S. to get away from some of this and now we’re seeing a return of some of the worst practices.”

Drug company officials say the concerns about their drugs in the United States are exaggerated by a hyper-vigilant Food and Drug Administration. The medications are widely--and legally--used with little complaint in Mexico, and the officials stress that those sold in Mexico were not intended for use in the United States.

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“We have to look at the FDA as a watchdog organization that protects its citizens to a fault,” said David Kempe, a senior product manager with Pharmacia & Upjohn, maker of two U.S.-restricted antibiotics marketed with lesser warnings in Mexico. “Other countries may not have felt that the warning had to be as strong.”

Lifshitz, the Cedars-Sinai doctor, charges that multinational drug companies that market dangerous medications in Mexico are “immoral.”

“It’s just like tobacco companies,” she said. “When they can’t sell as many cigarettes here, they go to another market.”

Lifshitz and others say that most developed countries have decided that risks of injury or death from certain drugs far outweigh their therapeutic value. For drugs such as dipyrone, there is no way to predetermine whom the drug will harm--and there are plenty of safer drugs that relieve pain and fever.

Lauren Parran, a spokeswoman for Hoechst Marion Roussel, which makes the world’s most popular brands of dipyrone, said comparing tobacco to medication is “not a valid analogy.”

“Tobacco has no therapeutic value,” she said. “Tobacco is injurious to the majority of people [who] use it. To liken it to a therapeutic product that in the vast majority of patients results in no injurious [events] . . . is irresponsible.”

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But critics say the repercussions of these practices are being tragically--and expensively--felt in the United States in hospitals and county clinics.

Los Angeles County-USC Medical Center has treated adults with swollen, moon-shaped faces, “buffalo humps” of fat behind their necks and out-of-kilter adrenal glands--believed to be the consequences of a Mexican-made arthritis drug. Most spend at least three weeks recovering in the hospital, racking up tens of thousands of dollars in bills, hospital officials said.

The scope of the problem is difficult to assess. The FDA tracks reactions only to approved drugs, and doctors at many hospitals often don’t have the time, or in some cases the cultural and linguistic skills, to unearth the role of these made-for-Mexico drugs in the illnesses of immigrant patients.

Worse, it’s clear that most immigrants are not warned of the possible consequences. The medications recovered in illegal shops here typically do not include any labels warning of the sometimes-fatal side effects.

Cancer Symptoms Without the Cancer

At a Costa Mesa swap meet last weekend, a Times reporter purchased tablets and liquids of Neo-Melubrina--Mexico’s most popular brand of dipyrone--as well as penicillin cream and capsules. Only the penicillin capsules included warning about a possible allergic reaction. None of the medicines came with dosage information, including the Neo-Melubrina liquid, which the merchant said could also be administered to infants.

In Mexico, some physicians say the drug companies don’t warn them clearly of possible complications.

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“The amount of information you get in the U.S. . . . is overwhelmingly different than what we get,” said Dr. Nadine Gasman, a public health physician in Mexico City. “Here the side effects are watered down and the indications are watered up.”

Gasman, who consults for the World Health Organization, said there is no outcry over the adverse side effects in Mexico. “Nobody is looking. Nobody is counting,” she said. “If children die and they have an infection, nobody will even think about [blaming] the drug.”

Dr. Sana Al-Jundi remembers the day in 1994 when a 2-year-old girl came into Children’s Hospital of Orange County in Orange.

The tiny child, the daughter of Mexican immigrants, was in full septic shock, her blood riddled with infection, her organs failing, her lungs filled with fluid. Her white blood cells, the body’s soldiers in the war against infection, were depleted.

It was as if the girl had cancer. But she didn’t.

The girl’s parents told Al-Jundi, a pediatric intensive care specialist, that they had been giving their daughter Neo-Melubrina to treat her fever.

Al-Jundi believes that Neo-Melubrina led to the girl’s death by suppressing her production of white blood cells--a well-known side effect dipyrone, called agranulocytosis, and the reason it was taken off the U.S. market. Dipyrone, under a host of brand names, is sold by 12 drug companies in Mexico and remains in wide use throughout Latin America.

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“The connection was just too close,” said Al-Jundi. “There is no other reason for a normal child to get sick so quickly.”

The girl, whom hospital officials declined to identify, was the second toddler at the hospital to die after being given Neo-Melubrina. A boy, also 2 and the child of Mexican immigrants, died after his white blood cell count plummeted in July 1993.

After the girl died, Orange County health officials attempted to warn the public of the drug’s dangers by issuing public health alerts and notifying the media. But the warnings, doctors said, appeared to have little effect.

Problems with the drug aren’t confined to California, or to Mexican immigrants.

In El Paso, Texas, Dr. John Haynes vividly recalls two children who died there after taking dipyrone. Tests in both cases showed the children were suffering from agranulocytosis.

“We know the complications of that medicine,” said Haynes, the medical director of the West Texas Regional Poison Control Center. “There would be no other reason for what happened.”

The only way to know for sure, Haynes said, would have been to perform a bone marrow biopsy, a procedure the cash-strapped hospital could ill afford. Haynes was unable to provide the children’s files because cases involving dipyrone are not required to be reported or flagged and the files, he said, are “buried among the 53,000 cases we see a year.”

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The drug isn’t just affecting children. A 51-year-old Oregon woman sought aid at a Missouri hospital in 1995 with a “horribly low white blood cell count,” remembered Dr. Victoria Dorr, who recounted her case in a medical journal. The woman kept saying that all she was taking was aspirin she had purchased in Mexico, Dorr said. The drug was, in fact, dipyrone.

“For a period of time, we did not think she was going to make it,” said Dorr, an assistant professor of medicine at the University of Missouri in St. Louis. “She was in the hospital a month and a half. She had no ability to fight infection at all.”

Hoechst’s Parran said the company, which makes Neo-Melubrina, could not comment on the children’s deaths “unless we had the entire medical records of the patients and knew for sure Neo-Melubrina was involved.”

“Of course we’re concerned if these are deaths that are linked to the drug,” Parran said. “But we’re getting a fourth-hand report.

“Even if you were to concede the point that the drug was linked to the deaths, if you have someone diagnosing the patients and dispensing the drug” who is not a physician, Parran said, it sets the stage for problems.

‘Mexican Aspirin’ Remains Popular

Doctors and pharmacists in the United States and in Mexico say dipyrone, known as “Mexican aspirin,” remains popular among Mexicans because it has long been widely sold and promoted.

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Dr. Antonio Arrieta, an infectious disease specialist at Children’s Hospital of Orange County, said his mother gave him the drug as a child in Peru because it “is good for pain and excellent for fever.” But, today, he said, physicians are less worried about bringing down fevers.

And, he added, “We are unwilling to pay the price to bring your fever down [with dipyrone].”

Dr. Luis Zavaleta de los Santos, director of the Mexican Doctors Assn., said, “Up to now there have been no cases of blood [diseases] reported in Mexico, and it is the No. 2 analgesic in our country. One could say this medicine is harmless for the population.”

But other doctors both here and in Mexico said such a blanket statement is irresponsible, especially when most of the drug’s buyers are not warned of the side effects and would not be likely to connect their problems to the drug.

“It’s also in the culture, people have used it for a long time,” said Gasman, consultant to the World Health Organization.

Dr. Francisco Manzano, a physician at Mexico City’s ABC Hospital, blames the Mexican Health Ministry for the easy availability of troublesome drugs. The drug companies, he said, could not sell drugs such as dipyrone in Mexico without the government’s consent.

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“I don’t use them. I do not prescribe them,” he said. “I go by the FDA.”

Lori Kraut, senior manager of global communications for Hoechst, said the worries about dipyrone’s side effects are exaggerated. Since the drug was withdrawn from the U.S. market in 1977, she said, research has shown that the risk of developing agranulocytosis is “extremely rare.”

Kraut cited two studies, both sponsored by Hoechst, that found the incidence of agranulocytosis was less than some previous reports had indicated. But both studies are disputed by some critics who question their methodology and independence, given Hoechst’s participation.

Developing Countries Are Major Market

Hoechst first patented dipyrone in 1911 and marketed the drug as an analgesic. Australia prohibited the drug in 1965, followed by a flurry of other countries that ordered the drug withdrawn or banned its use in combination products, such as stomach preparations, in the ‘70s and ‘80s.

Sweden initially banned dipyrone in 1974, but the drug was reintroduced in 1996 at the urging, in part, of Hoechst. Last month Sweden again prohibited the drug’s sale. In a letter to Swedish physicians, Hoechst said it agreed with Swedish health officials and would no longer sell dipyrone there because of a “larger than expected number of reports of agranulocytosis.” Sweden’s health authorities judged that one in 1,700 people who use the drug contract the potentially fatal blood disease, an unacceptably high rate.

Since 1997, three other countries--Nepal, Zimbabwe and, this year, Yemen--prohibited the sale of dipyrone.

Such criticisms, as yet, have not hurt sales of the drug in the 100 mostly developing countries where Hoechst says it markets dipyrone. The drug is the Germany-based company’s ninth or 10th largest seller, Kraut said. The company has estimated it sells 20 million doses of the drug a day. Global sales of the drug last year were $220 million, mostly in Latin America.

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Dipyrone sales in Germany, however, where Hoechst manufactures the drug, are tightly restricted. German health authorities banned all combination products made with dipyrone in 1990 and emphasized that pure dipyrone should only be used as a drug of last resort, primarily for tumor pain.

And publications worldwide continue to warn of its dangers. The Side Effects of Drugs Annual, a pharmacy reference, states that even taking into account the lowest risk estimates--more than 10 times lower than those recently seen in Sweden--it has been calculated that “22 cases of dipyrone-induced agranulocytosis would be seen daily, or over 7,000 cases annually worldwide.”

Some health advocates and doctors contend that about 20% to 50% of those who contract agranulocytosis in developing countries die of the disease. Even at those low case estimates, 2,000 people a year could be dying from dipyrone, they say.

But Dr. Peter Mansfield, director of the Australia-based Medical Lobby for Appropriate Marketing, worries that the new data from Sweden suggest the death rate could be much higher.

“With agranulocytosis you need sophisticated intensive care,” he said. “That’s just not available in many developing countries” where the dipyrone is primarily sold.

Gasman finds the double standard galling: “There’s no reason a drug that would not be good for Germans should be good for Mexicans. Why would a drug company produce things they are not allowed to sell in their own country?”

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Lee, the former U.S. assistant secretary of HHS and the co-author of several books on the marketing of drugs to developing countries, said the answer is obvious. “Clearly, profit comes well ahead of the public interest,” he said. “Clearly, they do it because they make 220 million bucks a year.”

Side Effect Warnings Omitted

Nearly every time the Los Angeles task force bursts into a shop selling Mexican pharmaceuticals, Thompson sees stacks of chloramphenicol: liquids for babies, capsules, eye ointments, eardrops and glass ampules ready to crack open and inject.

And every time he shudders.

“In American medicine, we wouldn’t use chloramphenicol unless it was the last resort,” said Thompson, who has headed the Los Angeles Regional Drug Information Center for 30 years. “Because the lawyers will have you down at the courthouse the next day if you hurt someone.”

The drug is a powerful, highly toxic antibiotic that is used only rarely in the United States and only under controlled situations. Its discovery in back-room clinics underscores the difference, doctors and pharmacists say, between its marketing in Mexico and the United States.

Nine companies sell the drug, alone or in combinations, in Mexico.

Even the drug’s U.S. marketer acknowledges chloramphenicol’s serious risks.

“It’s such a dangerous drug,” said Bill Smith, director of product information for Monarch Pharmaceuticals, which purchased the U.S. marketing rights to the brand Chloromycetin last year. “This is a last-ditch drug when nothing else will work.”

Inexpensive and strong, chloramphenicol is best used to battle such scourges as typhoid fever or Rocky Mountain spotted fever. The FDA considers it so toxic that since 1961 it has required the drug’s packaging to include a so-called “black box warning” detailing its risks.

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This warning, which includes an italic emphasis, states that “serious and fatal blood [diseases] occur after chloramphenicol administration. . . . [It] must not be used when less potentially dangerous agents are effective. It must not be used to treat trivial infections(i.e. influenza, colds, throat infections). . . . “

Thompson said he hasn’t found any package inserts detailing these adverse effects during sweeps of illegal pharmacies here.

“It’s shocking every time I see this stuff,” Thompson said. “It can stop your blood from being made.”

Mexican health authorities say doctors are increasingly prescribing safer alternatives to the drug, but they have little control over people who buy the drug because it has worked for them in the past and they never consult a doctor.

Said one U.S. doctor: “In Mexico they will take it for strep throat. Frequently you will not see the [bone marrow] suppression right away. People will develop another infection and die, and they will not connect it.”

The drug has had a controversial history in the United States. In the early 1970s, Parke-Davis, which first made the drug under the name Chloromycetin, paid out $400,000 to the family of a Long Beach woman who died after treatment with the drug. The state Supreme Court affirmed the jury’s finding that the drug firm “negligently failed to provide adequate warning as to the dangers of Chloromycetin by ‘watering down’ its warnings” and so over-promoted the drug that doctors prescribed it when it was not justified.

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Carol Goodrich, director of media relations for Parke-Davis’ parent company, Warner-Lambert, said the corporation has been ordered by the Mexican Health Ministry not to include package inserts for consumers in order to prevent them from self-medicating.

Goodrich said the Mexican government, not Warner-Lambert, is responsible for alerting the drug’s users, even if the company knows people are buying the drug without consulting a doctor.

“It’s a serious situation, and it’s unfortunate if patients are not getting the information they need to have,” she said. But Warner-Lambert is “following the regulatory authorities in every region we do business.”

Another company that sells chloramphenicol in Mexico, Pharmacia & Upjohn, also makes an antibiotic called Lincocin, which in the United States must include a “black box” warning that it can cause fatal colitis. The company no longer markets the drug here and makes a less toxic alternative.

So it came as a shock to health authorities to discover box after box of injectable made-for-Mexico Lincocin in Los Angeles raids over the last year. As with the other drugs, there were no warnings of fatal colitis.

“I probably haven’t seen a prescription for this in 25 years,” said Thompson, “and here we are finding it in every bust. There are so many drugs that are safer than this.”

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Upjohn’s Kempe said the Mexican Lincocin was never intended to be sold to Americans and says the drug has been proven much safer than the U.S. warnings indicate.

“We expect our products that we market to stay in those countries. We don’t ever expect them to cross the borders,” he said. “The reasons for that is the labeling issues.”

Horrific Side Effects

Eight times over the last two years, people have crept into County-USC Medical Center in pain, their faces bloated to a round moon shape, their eyes bulging and a “buffalo hump” of fat behind their necks, according to hospital records.

Each of them said they had been taking Artridol, an arthritis drug sold in Mexico--and found in every back-room shop raided here--by a Mexican drug firm called Rimsa.

The drug, a potent combination of a muscle relaxant, an anti-inflammatory and a steroid, initially makes the user feel great. But if the user follows the manufacturer’s instructions and continues to take the pills three times a day, the steroid begins to shut down the adrenal gland and weaken the bones, Thompson said. The user may develop the moon face typical of an inflammatory syndrome called Cushing’s disease, Thompson said.

By the time they reach the emergency room, he said, the users will probably spend three weeks in the hospital recovering. “We’d never allow something like this” to be prescribed in the United States, he said.

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But in Mexico, Artridol can be easily purchased at pharmacies without any warnings of Cushing’s disease. And no one, many doctors say, tracks how many people turn up in emergency rooms swollen and disfigured by the drug.

Dr. Maria Elena Garcia, chief of scientific research at Rimsa, agreed that Artridol is “very risky to take it on your own. It must be prescribed by a doctor.”

But she said Rimsa conducted intensive toxicity studies of Artridol on animals and patients that revealed no significant ill effects. “The use of steroids is known to be able to cause side effects, but when it is properly indicated and well managed, it is a useful tool for doctors,” she said.

“We have never tried to sell this product in the United States,” Garcia said. “If someone is buying it in Mexico and taking it across the border, that is out of our hands.”

But critics say little is done to protect Mexican consumers from drugs such as Artridol.

Despite laws ostensibly limiting the drugs that can be purchased without a prescription, virtually any nonnarcotic drug can be bought over the counter like a candy bar or a pack of cigarettes. The stores often are staffed by untrained clerks, unaware of the drug’s side effects or indications.

Drug companies in Mexico, Gasman said, “take advantage of the weakness of the system. Given these kind of drugs when you know there’s so many lethal side effects . . . they have some social responsibility they are not fulfilling.”

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But Dr. Luis Fernando Hernandez Lezama, a senior advisor in the Mexican Health Ministry’s regulatory department, said Americans may have more reason to be concerned about the side effects of drugs such as dipyrone.

“In the U.S. [dipyrone’s use] led to a significant number of cases of blood [diseases] as a side effect,” he said. “Fortunately in Mexico’s case this doesn’t happen so much. It may have something to do with race. As the number of cases reported [in the U.S.] was high, maybe white people are more affected.”

Thompson and several other scientists said such an argument regarding an analgesic or antibiotics such as chloramphenicol is “total nonsense.”

“We have certainly seen up here Hispanics that have had reactions to these drugs,” Thompson said.

Cedars-Sinai physician Lifshitz contends the differing drug standards in Mexico and the United States end up hurting far more people than anyone knows--on both sides of the border.

“I think it’s scary,” she said. “These drugs are toxic.”

Times staff writer James F. Smith and researcher Greg Brosnan in Mexico City and staff writer H.G. Reza in Orange County contributed to this story.

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(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

From Drug Companies, to Mexico to Southern California

1. Drugs banned or restricted in U.S. are manufactured internationally. Some end up in Mexico.

2. and are transported to Tijuana.

3. sold to buyers in farmacias.

4. smuggled across the border

5. and resold at U.S. swap meets and botanicas.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

About This Series

After two Orange County infants died following treatment and injections of medication by illegal providers serving Latinos, The Times assembled a team of reporters here and in Mexico to investigate this underground medical phenomenon. The team spent three months following the trail of dangerous medications from Mexico, through the border and into Southern California.

Today: The back rooms of some markets, dress shops and swap meets peddle drugs that are banned or tightly restricted in the United States because of severe side effects that can kill. These drugs are smuggled in from Mexico, where looser drug laws allow multinational drug companies to sell them much more freely.

Monday: Millions of prescription drugs are pouring into the United States from border towns, virtually unchecked by customs inspectors more intent on stopping contraband like cocaine.

Tuesday: Economic, political and cultural forces push many immigrants to seek help from unlicensed medical providers using illegal or unproven drugs. These immigrants either reject the U.S. system of health care or conclude that it has rejected them.

The entire series will be available on the Times Web site: www.latimes.

com/mexdrugs.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Brand Names and Manufacturers of Frequently Seized Drugs

The following drugs are among the most common medications seized in raids of back room pharacies and illegal clinics in Southern California. These medications have been banned or highly restricted in the United States because of severe, potentially fatal side effects. Drugs in italics are those most commonly found in U.S. raids:

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Generic names: Dipyrone, “Mexican aspirin,” Metamizole

Brand names: Conmel, Conmel Plus, Dalmasin, Fardolpin, Magnol Atlantis, Magnopyrol, Neo-Melubrina, Prodolina, Utidol

Brand names of medicines that include dipyrone: Anespas Compuesto, Bipasmin Compuesto, Buscapina Compositum, Busconet, Busprina, Buticina Compuesta, Colepren, Retodol Compositum, Selpiran

Manufacturers: Atlantis, Columbia, Diba, Farcoral, Hoescht Marion Roussel, Promeco, Quimicason’s, Randall, Rimsa, Rudefsa, Sanofi Winthrop, Siegfried

Uses: Severe pain, fever. Is mixed with other medications for stomach, gastrointestinal and kidney pain, nausea and vomiting.

Warnings: associated with fatal immune-deficiency disease caused by severe loss of white blood cells, bone marrow destruction, increased risk of shock

Misuses: Minor pain, headaches

Status: FDA approval withdrawn: 1977

Generic name: Chloramphenicol

Brand name: Chloromycetin, Clorafen, Cloramfeni Ofteno (eye infections), Cloramfeni Ungena (eye infections), Cloran, Clordil, Paraxin, Quemicetina

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Brand names of medicines including chloramphenicol: Cloran Otico Grin, Fibrase, Levodexan, Levofenil, Pre Clor, Soldrin Otico, Sulfa Cloran Grin, Ulcoderma Unguento

Manufacturers: Columbia, Diba, Grin, Grupo Warner-Lambert (Parke-Davis), Lakeside, Merck Mexico, Pharmacia & Upjohn, Quimica Knoll, Sophia,

Uses: Infections in patients with cystic fibrosis, typhoid fever, Rocky Mountain Spotted Fever, cholera, meningitis. Is used alone or in combination drugs for ear and eye infections.

Warnings: Can cause fatal blood diseases leading to leukemia, irreversible bone marrow depression, gray baby syndrome

Misuses: Bacterial infections, trivial infections like influenza, colds, throat infections

Status: FDA required that drug inserts include a “black box warning,” its most severe warning, 1961.

Generic name: Lincomycin, Lincomicina

Brand names: Lincocin, Princol, Rimsalin

Manufacturers: Pharmacia & Upjohn, Provit, Rimsa

Uses: Serious streptocuccus, staphyloccus infections

Warnings: Can cause fatal colon inflamation, associated with fatal “gasping syndrome” in premature infants, jaundice

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Misuses: Upper-respiratory tract infections, minor bacterial or viral infections, meningitis, gonorrhoeae

Status: FDA required that drug inserts include a “black box warning,” its most severe warning, 19975.

Generic name: Betamethasone, methocarbamol, indomethacin

Brand name: Artridol

Manufacturers: Rimsa

Uses: Rheumatism, bursitis, tendonitis, arthritis

Warnings: May cause drop in white blood cell count, moon face disfiguration known as Cushing’s syndrome, intestinal bleeding

Misuses: Minor pain, convulsions, ulcers, hypertension

Status: Drug has never been submitted for use in the United States.

Sources: Drug Facts & Comparisons, Martindale Pharmcopoeia, Mexican Dictionary of Pharmaceutical Specialties, drug insert literature

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