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Is it safe to take expired accutane
The acne drug Accutane is one of the most dangerous products on the market today. The drug causes serious side-effects, most notably birth defects.
Accutane is also one of the most effective prescription drugs available. This combination—unique efficacy coupled with unique risk—has posed a serious challenge for the Food and Drug Administration FDA. Over the past two decades, FDA has grappled with how manage the completely preventable but persistently serious problem of Accutane-induced birth defects. On several occasions, the product spurred FDA to take unprecedented regulatory action.
In when American researchers for Hoffmann-La Roche began studying the chemical, isotretinoin, they were struck by its remarkable effectiveness. This may seem like undue attention for a simple pimple remedy, but in actuality severe acne can be a seriously debilitating condition. Much more than the familiar blackheads, the condition is marked by tremendous pus filled lesions which typically spread across the entire face and neck leaving behind pitted scars.
One FDA official noted that the cysts can be so "cosmetically crippling that people cannot get jobs. I am now confident, happy and very excited about life. I no longer feel inferior and can actually look people in the eyes.
About 12 million people worldwide including 5 million Americans have taken Accutane, which is called Roaccutane outside the United States.
But as productive as it is, both as a money-maker and a therapy, Accutane also has the potential to destroy lives. Accutane is an extremely dangerous teratogen: it can cause severe birth defects when taken during pregnancy.
About one quarter of babies born who have been exposed to Accutane during gestation have major congenital deformities. Those babies born without major malformations frequently develop severe learning disabilities. Edward Lammer, a medical geneticist and consultant to FDA, describes the overall risk posed by Accutane:. This is an extraordinarily high absolute risk, really comparable, in terms of environmental exposures, only to Thalidomide or certain congenital infections.
There is no other medication that poses an absolute risk anything remotely close to this, even medications used to treat cancer during pregnancy. According to Dr. Lammer, brain abnormalities are the most typical problem for Accutane babies, even babies who appear normal at birth i.
In addition, Accutane commonly inhibits the development of the bones and cartilage of the face. Children may be born with no ears at all; sometimes there are small slits in the place of ears. Heart defects, which often grow fatal, characterize the third most common problem described by Dr.
Since its approval in , references to Accutane have peppered the pages of law reviews and other publications. The drug has become an example for academics and others proposing reform.
But none of these accounts has offered a full history of Accutane in the U. This paper takes a journalistic approach, tracing the chronology of Accutane in the U. Accutane has repeatedly pushed the frontier of FDA regulation, as the agency struggled to adapt its tools to meet the challenge of an extremely effective and extremely dangerous medication. By emphasizing the evolving American response to the high level of risk associated with Accutane, I hope to provide the material needed to evaluate the strengths and weaknesses of our current regulatory framework.
Discovery and Pre-Market Approval : Perhaps the biggest challenge in chronicling Accutane has been to decipher the early history of the drug.
Creating a narrative has required piecing together fragments of the puzzle which surfaced over the course of the past decade. One might blame Roche: the company has repeatedly gone to court demanding that material describing the development of Accutane be kept private.
But some believe that the Roche exploits that authority in order to keep certain details—details which might reflect poorly on the company—obscured. Werner Bollag first studied the chemical compound, cis retinoic acid at Roche laboratories in Switzerland during the s.
But Bollag also realized that the drug could cause serious birth defects. The compound derived from vitamin A, a known teratogen. When it proved ineffective as a cancer therapy he abandoned the project.
In their research, Drs. Frank Yoder and Gary Peck accidentally discovered that the chemical also cleared up acne. Subjects who had been covered with pimples returned to the office with clear skin. Isotretinoin became Accutane, and in clinical trials researchers carefully avoided exposing pregnant women to the drug. Hoffmann-La Roche had conducted animal studies, and offspring of subjects showed facial deformities much like the ones that have subsequently been seen in Accutane babies.
Those researchers who did include women in trials required a negative pregnancy test and contraceptive use.
FDA provides administrative support to the Dermatologic Drugs Advisory Committee, which includes several dermatologists, other medical experts and a consumer representative. But the Committee also urged that the label be revised.
There are no adequate and well-controlled studies in pregnant women. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Although FDA heightened the pregnancy risk rating for the drug, the original label did not suggest the careful precautions that Roche itself had used during clinical trials.
Instead, the label noted the fact that there had been no evidence of birth defects in humans. In May , nine months after the application had been submitted, FDA announced approval of Accutane. According to a Hoffmann-La Roche spokeswoman quoted in the Washington Post , "Approval came through so fast that it came as quite a surprise to everyone The United States was the first country to approve Accutane. In September , Accutane arrived to a warm welcome.
News and World Reports stated that Accutane could clear up most cases of acne within a few months. At the same time, some of the doctors who had studied the drug began to voice alarm. Henry J. Roenigk had been chairman of the dermatology department at Northwestern University and participated as a researcher for Roche during clinical trials.
The potential toxicity of this drug has been seriously under-emphasized. Hoffmann-La Roche reproached the scientists for releasing information obtained while working for the company. Yoder claims that he received a hostile phone call from Roche executives. According to him, Roche representatives ''angrily told me I should not be writing that sort of confidential information. I didn't agree with them.
I thought the public good must be served. Shortly afterward the company sent letters to all scientists who had participated in clinical trials, stressing the confidentiality of information obtained during research sponsored by Hoffmann-La Roche.
Within a few months, Hoffmann-La Roche began receiving stories about of babies born with severe birth defects to women who had taken Accutane. In June —nine months after the drug had been released—three cases were reported to Roche. The company also revised the drug label to include more information about birth defects and a more prominently placed warning.
In addition, Public Citizen asked FDA to require patient package inserts explaining the possible side-effects in non-technical language. In the first 18 months of marketing, about , patients took Accutane.
By March , Roche collected reports of 20 Accutane babies. The label explicitly suggested that patients use contraceptives beginning a month before therapy.
In addition, FDA advised blood banks to refuse donations from Accutane users. Between and Roche delivered seven more Dear Doctor letters warning about Accutane. Practitioners have suggested that FDA requires a black box warning when it hopes to decrease sales of a drug. On April 22, four days before the scheduled meeting, an account of the confidential FDA memo appeared on the front page of the New York Times. News of the large estimated number of Accutane babies—combined with the large number of abortions suggested to have been caused by the drug—sparked a craze of media attention.
Journalists questioned whether the manufacturer and doctors had pushed the drug too far and whether FDA had approved the drug too quickly. We must not allow the advisory committee process to be used as an excuse to permit such a seriously birth-deforming drug to remain on the market. Yoder also described the firm safeguards that had been in place during testing to ensure that no pregnant women were exposed to the drug. This was very, very wrong. One source of controversy was the disparity between Accutane use in the U.
As of April 30, only three Accutane babies had been born in Europe. In Switzerland, doctors had to register with the government to prescribe it. In the United Kingdom, only dermatologist had authority to prescribe Accutane and only hospitals could dispense it. As a prerequisite to receiving the drug in Britain, a woman had to stipulate that she would be willing to have an abortion.
Sweden never approved Accutane for general use; dermatologists applied for special permission when a patient had a particular need. In Spain, the Ministry of Health kept the name and address of every woman taking Accutane in a special registry. The European approach to Accutane reflected not just a different regulatory methodology, but also differing circumstances.
In the wake of Thalidomide, Europeans treated all teratogenic drugs extremely cautiously. The Committee meeting on April 26th was just as contentious as the public debate that preceded it.
Hoffmann-La Roche proposed an aggressive education program to reduce the risk of pregnancy. The Committee recommended that only a limited number of certified physicians be permitted to dispense the drug. In addition, women at high-risk of pregnancy would be required to procure a second opinion before receiving Accutane. Questioning whether it had the authority to dictate who could prescribe the drug, FDA instead mandated new warnings for the label.
The agency required that Hoffmann-La Roche provide informed consent forms to be signed by patients and doctors. In addition the FDA directed the company to double the type size in the warning; include a picture of a baby deformed by Accutane in the material going to patients; dispense the drug in a blister-pack with warnings on every package; instruct doctors that they should give both written and oral warnings; add a symbol of a pregnant woman crossed out on the material given to doctors and patients; and conduct follow-up studies to determine the efficacy of the new program.
New study may deal final blow to acne drug Accutane - Los Angeles Times - Site Information Navigation
Is it safe to take expired accutane
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Photo by Sandy Huffaker for ProPublica. The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the moon landing.
Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless. But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals.
Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects. Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.
The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. ProPublica has been researching why the U. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted.
Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants.
All the drugs tested were in their original sealed containers. The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost percent of their labeled concentrations.
Cantrell and Gerona knew their findings had big implications. Perhaps no area of health care has provoked as much anger in recent years as prescription drugs. The news media is rife with stories of medications priced out of reach or of shortages of crucial drugs, sometimes because producing them is no longer profitable. Tossing such drugs when they expire is doubly hard. After Cantrell and Gerona published their findings in Archives of Internal Medicine insome readers accused them of being irresponsible and advising patients that it was OK to take expired drugs.
But after a brief burst of attention, the response to their study faded. It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years. For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.
Maintaining these stockpiles is expensive. Luckily, the country has rarely needed to tap into many of the drugs, but this means they often reach their expiration dates. Instead, for more than 30 years, it has pulled some medicines and tested their quality. The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients.
It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Most companies, she says, would rather sell new drugs and develop additional products.
Industry officials say patient safety is their highest priority. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it. The federal agencies that stockpile drugs — including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs — have long realized the savings in revisiting expiration dates.
Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. A study of drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested.
Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences. Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs.
Cantrell says there has been no recorded instance of such harm in medical literature. He says the high price of drugs and shortages make it time to reexamine drug expiration dates in the commercial market. Some medical providers have pushed for a changed approach to drug expiration dates — with no success. Inthe American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates.
Federal and state laws prohibit pharmacists from dispensing expired drugs and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply.
And then the bins fill again. One of the plastic boxes is piled with EpiPens — devices that automatically inject epinephrine to treat severe allergic reactions. These are from emergency kits that are rarely used, which means they often expire. Photo by Erik Jacobs for ProPublica. The EpiPens also contain liquid medicine, which tends to be less stable than solid medications.
Testing showed 24 of the 40 expired devices contained at least 90 percent of their stated amount of epinephrine, enough to be considered as potent as when they were made. All of them contained at least 80 percent of their labeled concentration of medication. The takeaway? At Newton-Wellesley, Berkowitz keeps a spreadsheet of every outdated drug he throws away. Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses.
He holds up a purple box of atropine, which gives patients a boost when they have low heart rates. The FDA study of the extension program also said it pushed back the expiration date on lots of mannitol, a diuretic, for an average of five years. Berkowitz has to toss his out. Expired naloxone? The drug reverses narcotic overdoses in an emergency and is currently in wide use in the opioid epidemic. The FDA extended its use-by date for the stockpiled drugs, but Berkowitz has to trash it.
On rare occasions, a pharmaceutical company will extend the expiration dates of its own products because of shortages. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates. The news sent Berkowitz running to his expired drugs to see if any could be put back into his supply.
His team rescued four boxes of the syringes from destruction, including 75 atropine, 15 dextrose, epinephrine and 22 sodium bicarbonate.
Four scientists who worked on the FDA extension program told ProPublica something like that could work for drugs stored in hospital pharmacies, where conditions are carefully controlled. An independent organization could also do testing similar to that done by the FDA extension program, or data from the extension program could be applied to properly stored medications.
ProPublica asked the FDA whether it could expand its extension program, or something like it, to hospital pharmacies, where drugs are stored in stable conditions similar to the national stockpile.
Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for their newsletter. Support Provided By: Learn more.
Monday, Oct The Latest. World Agents for Change. Health Long-Term Care. For Teachers Newshour Classroom. NewsHour Shop. About Feedback Funders Support Jobs. Close Menu. Email Address Subscribe. Yes Not now. Leave your feedback. Share on Facebook Share on Twitter. Is it safe to take expired medications? Additional Support Provided By:.DONT take expired medication, especially accutane. I'm pretty sure you can return it at a pharmacy in exchange for new prescriptions. Although. localhost › Accutane › comments › acci. Please take any unused capsules to your pharmacist at the end of treatment. Advice for all patients. Talk to your doctor before taking Isotretinoin if you have. A notable issue with expired medicines is reduced efficacy, but some, like the antibiotic tetracycline, can degrade into toxic chemicals. I am on 5th day of taking accutane pills & I'm wondering if I can take Biotin, Keratin, and B12 supplements while on it? March 22, Asked By. Business Visionaries. Frank Yoder, in some ways a patron Saint of Hoffmann-La Roche—after all, his discovery had resulted in a tremendous money maker for the company—had spent the past fifteen years insulting Roche in the Washington Post. For now, generic versions are still available, but the latest troubles could lead to the withdrawal of the controversial medication considered the treatment of last resort for acne so damaging it can lead to pitting of the face and a lifetime of anguish. By MarchRoche collected reports of 20 Accutane babies. But none of these accounts has offered a full history of Accutane in the U. FDA asked the two groups to address this question: had the pre adverse public health situation changed in a meaningful way and to a meaningful extent? The United States was the first country to approve Accutane.
Teenagers and young adults suffering from severe, scarring acne may ultimately lose the most effective treatment for the condition. The article said the study showed 1. Instead, the study showed that 1. Swiss-based Roche Holding quietly pulled its blockbuster drug Accutane off the market in June amid early signs that the drug may be linked to inflammatory bowel disease. And last week, a study was released that quantified those risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as nonusers.
For now, generic versions are still available, but the latest troubles could lead to the withdrawal of the controversial medication considered the treatment of last resort for acne so damaging it can lead to pitting of the face and a lifetime of anguish.
In its tumultuous year history, the drug, also known as isotretinoin, has been found to cause serious birth defects if taken during pregnancy and to possibly increase the risk of depression, including suicidal behavior. When approved in , the drug was known to cause birth defects if taken during pregnancy and was labeled with warnings to that effect. The program has kept isotretinoin on the market, although the system is so cumbersome that some doctors and patients have given up trying to obtain the medication, says Dr.
Amy Forman Taub, a dermatologist and assistant clinical professor at Northwestern University in Chicago. Isotretinoin can cause other side effects, including increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol and liver toxicity.
The drug has been publicly and emotionally linked to an increased risk of depression, including suicides, and some families of suicide victims have pressed the FDA for its removal -- among them Rep.
Bart Stupak D-Mich. A study published in January in the Annals of General Psychiatry, however, found that the relationship between isotretinoin and psychiatric problems is unproved. Now research has found a possible link to inflammatory bowel disease. Last week at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of bowel disorders in isotretinoin users.
Before the study, the connection was largely anecdotal. In inflammatory bowel disease, the intestines become chronically red and swollen, producing pain, cramping, diarrhea, weight loss and bleeding. Surgery to remove all or part of the colon is sometimes required. Seth Crockett and his colleagues compared 8, cases of inflammatory bowel disease with 21, healthy individuals and found the odds of developing such diseases were 1.
People who had filled four or more prescriptions had 2. The odds of having ulcerative colitis, a type of bowel disease that causes open sores in the lining of the rectum and colon, were 4.
But only about 5 to 10 people in , are diagnosed with inflammatory bowel disease each year, Crockett said. Because the data have not yet been published in a peer- reviewed journal, Crockett noted, they must be considered preliminary.
And a similar study, published in July in the American Journal of Gastroenterology by University of Manitoba researchers, found no such association. That study examined a large database in Canada and found that 1.
A statement by Roche said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits, not safety concerns. The new data are certain to spark renewed opposition to the drug, said Michael S. Brown, an Encino-based lawyer who specializes in personal-injury claims. The intent of the lawsuits is to drive the medication off the market, he said. The isotretinoin patients he represents were not told of a potential increased risk of bowel disease, Brown said. Taub, the Northwestern dermatologist, says she will include the most recent information on risk in her long discussions with patients who are candidates for the medication.
But she worries about a future with nothing to offer people with severe acne. Get the day's top news with our Today's Headlines newsletter, sent every weekday morning. You may occasionally receive promotional content from the Los Angeles Times. All Sections. About Us. B2B Publishing. Business Visionaries. Hot Property. Times Events. Times Store. Special Supplements. Facebook Twitter Show more sharing options Share Close extra sharing options. By Shari Roan.
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