Drug Injury Watch

Popular Asthma Medicine Singulair Associated With Psychiatric Disorders In Children

2009-07-04T11:14:00-04:00

New Medical Journal Article Follows June 2009 FDA-Required Warning For Singulair About Neuropsychiatric Events

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 12, 2009 the FDA announced a new warning about an increased risk of neuropsychiatric events for the asthma medicine Singulair (montelukast)-- as well as some other less popular leukotriene inhibitors, Accolate (zafirlukast) as well as Zyflo and Zyflo CR (zileuton).

This announcement was followed closely by a medical journal article, "Montelukast and psychiatric disorders in children.", which was published in the June 23, 2009 edition of Pharmacoepidemiology and Drug Safety. The Abstract for this new Singulair article starts with a relatively ominous line: "A signal has been raised concerning montelukast and adverse drug reactions (ADRs) in children."

This June 2009 Singulair medical journal article presents the findings of a study whose purpose was "to evaluate psychiatric ADRs during treatment with [Singulair (montelukast)] in children." For this purpose, a team of researchers from Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, Göteborg, Sweden, analyzed all reports of psychiatric disorders during treatment with Singulair in children under age 18 in the Swedish ADR database SWEDIS for the period 1998 to 2007.

From the Abstract for this Swedish Singulair study concerning adverse reactions in children:

RESULTS: A total of 48 reports of psychiatric disorders in children during treatment with montelukast were found in SWEDIS. Reports appeared every year after registration. Psychiatric disorders reported more than once included nightmares (n = 15), unspecified anxiety (n = 11), aggressiveness (n = 11), sleep disorders (n = 10), insomnia (n = 3), irritability (n = 3), hallucination (n = 3), hyperactivity (n = 3), and personality disorder (n = 2). In 23 reports (48%), the child experiencing psychiatric ADRs was ADR was indicated in 35 reports. In 28 of these (80%), the time from exposure to ADR was less than 1 week. A statistical signal for psychiatric disorders appeared in the fourth quarter of 1998 (three reports, IC-value: 2.34, 95% lower confidence limit: 0.62).

These findings led the researchers to conclude that psychiatric adverse reactions can occur in children during their treatment with Singulair (montelukast), which indicated to them that "[f]urther studies are needed to establish the magnitude of the problem."

We agree that more research should be done, and soon, about the extent of Singulair possibly causing psychiatric disorders in children using this very popular asthma drug from Merck.

Smoking Cessation Drugs Chantix, Wellbutrin, And Zyban Are Getting New "Black-Box" Warning

2009-07-01T16:06:51-04:00

Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide

(Posted by Tom Lamb at DrugInjuryWatch.com)

On July 1, 2009 the FDA issued a Public Health Advisory about Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning:

...highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease.

Contemporaneous with this July 1 FDA Public Health Advisory the FDA issued a news release -- "FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban" -- and a document intended primarily for relevant medical professionals -- "Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)".

This second item had some concise and helpful background information about the history of safety issues concerning Chantix, Wellbutrin, and Zyban:

FDA first informed the public about the possibility of serious neuropsychiatric symptoms with [Chantix] in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. A complete history of related communications on [Chantix] and [Wellbutrin / Zyban] can be found at: Varenicline (marketed as Chantix) Information. Since that time, information about serious neuropsychiatric symptoms in patients taking varenicline has been added to the POST-MARKETING EXPERIENCE section of the prescribing information.

As FDA received additional information the suggestion of a possible association between both varenicline and bupropion (which was evaluated as a comparator to varenicline) and serious neuropsychiatric symptoms, in both patients with and those without previous history of psychiatric illness, became more evident as its review progressed....

We will watch for corporate press releases from Pfizer (which sells Chantix) as well as GlaxoSmithKline (which sells Wellbutrin and Zyban) which might be issued to present the drug company's reaction to this FDA announcement about adding a black-box warning for neuropsychiatric side effects being added to their respective product's Package Insert, or label.

Brandname Accutane Acne Medicine Is Being Removed From U.S. Market By Roche

2009-06-28T21:17:00-04:00

Accutane Recall Due To Safety Issues Or Declining Sales Or Lawsuit Losses Or Some Combination Of These Factors?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 26, 2009 we learned from a Blooomberg news report, "Roche Pulls Accutane Off Market After Jury Verdicts", that Accutane will no longer be available to American patients:

Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

From the above information, the apparent reasons for this June 2009 Accutane recall are loss of market share and mounting personal injury lawsuits.

This brought to mind the Tequin recall by Bristol-Myers Squibb (BMS) in April 2006.

Here is an article from September 2009 regarding what the FDA had to say about how and (really) why BMS decided to remove its unsafe antibiotic Tequin from the U.S. market -- "FDA: Tequin Was Withdrawn From U.S. Market "For Reasons Of Safety Or Effectiveness" -- Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin" (emphasis added):

On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. (BMY) decided to pull Tequin from the U.S. market in the spring of 2006:

SUMMARY: The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin).

As you may recall, in April 2006 when the news first broke that Bristol-Myers had decided to stop selling Tequin -- an antibiotic which was increasingly associated with potentially fatal blood-sugar problems -- the drug company said a continuing decline in Tequin sales was its reason for deciding to stop selling Tequin.

Returning to the June 26 Bloomberg article and its headline which implicates the Accutane lawsuit losses as being the primary reason for Roche deciding to pull Accutane, there have been some recent developments in the Accutane litigation.

In mid-June a New Jersey Superior Court judge ruled that Roche could not name new experts in the retrial of Andrew McCarrell v. Hoffman-La Roche Inc., et al.(No. ATL-L-1951-03-MT, N.J. Super., Atlantic Co.), a personal injury case where the plaintiff had alleged Accutane caused his inflammatory bowel disease (IBD). I defer to a March 13, 2009 post on the Drug and Device Law blog, "Accutane: McCarrell Remanded For New Trial", concerning the appeal of this Accutane jury verdict for the plaintiff.

A better result in June 2009 for Roche came from the federal court system's 11th Circuit Court of Appeals, which upheld a summary judgment in favor of the drug company in a case where it was alleged that Accutane caused the son of U.S. Rep. Bart Stupak, D-Mich., to commit suicide. The essential ruling reportedly there was that the plaintiff failed to produce evidence that Hoffman-La Roche Inc. knew or should have known that Accutane could cause suicide without premonitory symptoms (Laurie A. Stupak v. Hoffman-La Roche Inc., et al., No. 07-15980, 11th Cir.; 2009 U.S. App. LEXIS 12482).

We will watch to see if more information comes out in the future which will explain why Roche decided to remove Accutane from the market in June 2009.

Generic Drug Maker Caraco Fails To Correct Manufacturing Problems First Discovered In May 2008

2009-06-26T16:24:15-04:00

FDA And U.S. Marshals Seize Drug Products From Caraco’s Three Michigan Facilities Due To Continuing Lack Of Quality Controls

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 25, 2009 the FDA issued a press release, "U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. -- FDA acts to prevent repeated drug quality problems", which began as follows:

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities....

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

On March 31, 2009 Caraco recalled its digoxin pills due to the possibility that some of those pills might be oversized and contain too much active ingredient. Because digoxin is known to have a narrow therapeutic index, it is possible that oversized Caraco digoxin pills caused digitalis toxicity, or digoxin poisoning, in patients using that product.

Earlier, the FDA issued a warning letter to Caraco in October 2008 after FDA inspectors had discovered failures to conform to current Good Manufacturing Practices (cGMP) at some of the companies facilities.

The FDA has provided a list of the 33 Caraco drugs that may be affected by the June 25, 2009 seizure at the company's three Michigan plants.

Merck's Popular Asthma Drug Singulair Associated With Suicide And Depression

2009-06-23T17:44:53-04:00

FDA Has Gone From "No Link" In January 2009 To Wanting An Increased Warning About These Neuropsychiatric Events In June 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 12, 2009 the FDA announced that Singulair (montelukast) as well as some other less popular leukotriene inhibitors -- Accolate (zafirlukast) as well as Zyflo and Zyflo CR (zileuton) -- must start to include a warning on its package insert, or label, regarding an increased risk of neuropsychiatric events including suicide and depression.

This June 2009 FDA warning about Singulair is seemingly a reversal from an earlier position taken by the FDA in January 2009 when the agency said their review of clinical trials did not suggest Merck's Singulair asthma drug caused suicide or suicidal thoughts.

For some perspective, let's look back in time to see how this Singulair - suicide link has become a very significant emerging drug-safety issue at the FDA.

We start with a March 27, 2008 ABC News report, "Doctors Not Concerned by US FDA Probing Safety of Merck's Singulair":

The Food and Drug Administration (FDA) announced an investigation Wednesday examining a link between suicide and Merck's popular allergy and asthma drug, Singulair.

Concerns over "behavioral issues" with Singulair developed over the past year. Merck periodically updated the drug's labels to include warnings for tremors, depression and anxiety. FDA spokesperson Susan Cruzan said reports of suicides by "three or four" people who were taking Singulair prompted Merck to clarify suicide warnings on labels and patient information sheets in October 2007.

We get some additional background information from a March 27, 2008 article, "FDA Investigates Possible Suicide Link With Montelukast (Singulair)", published online by MedPage Today:

The FDA said it will probably take at least nine months for it to complete a safety review of the popular asthma and allergy drug montelukast (Singulair).

The ongoing investigation is examining a possible association between use of the drug and behavior/mood changes, suicidality (suicidal thoughts and behavior), and suicide, the agency said....

Over the past year, the maker of Singulair, Merck & Co, has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

From there we move forward to a January 14, 2009 Reuters article, "FDA says Singulair data do not suggest suicide link":

U.S. regulators on Tuesday said their review of clinical trials does not suggest Merck & Co's Singulair asthma drug or similar medicines cause suicide or suicidal thought, although the data were inadequate to draw a firm conclusion....

The agency also studied trials involving two other medicines that work by blocking inflammation-causing proteins called leukotrienes, AstraZeneca Pls's Accolate (zafirlukast) and Zyflo (zileuton) sold by Cornerstone Therapeutics Inc.

"Although these data do not suggest that [Singulair (montelukast), Accolate (zafirlukast) or Zyflo and Zyflo CR (zileuton)] are associated with suicide or suicidal behavior, these clinical trials were not designed specifically to examine neuropsychiatric events," the FDA said. "As a result, some events may not have been reported."

Concerns about a possible suicidal link have arrested sales growth of Singulair, Merck's biggest product with annual sales of almost $4.5 billion.

Then came the June 2009 announcement from FDA that there may be a link between Singulair and suicide. From a June 12, 2009 MedPage Today article, "FDA: Leukotriene Inhibitors Associated with Suicide, Depression":

Leukotriene inhibitors must include a warning regarding increased risk of neuropsychiatric events including suicide and depression, according to the FDA.

The requirement applies to montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). All are approved to treat asthma, and montelukast is also approved to treat symptoms of allergic rhinitis and to prevent exercise-induced asthma.

Upon completing a review of the agents in April, the FDA found reports of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicide, suicidal ideation, and tremor associated with use of the drugs.

The FDA based its review on postmarket reports and clinical trial data submitted by the manufacturers of the drugs....

The FDA said physicians should consider discontinuing the medications if patients develop neuropsychiatric symptoms.

Now that the association between Singulair and neuropsychiatric events such as suicide and depression has been announced by the FDA, we expect there to be additional case reports about Singulair users experiencing these serious side effects.

As always, we encourage people with personal knowledge about serious side effects from Singulair use to submit a MedWatch report to the FDA. We also welcome Comments, here, from people who want to share with others their side-effect experiences, or that of a family member, while using Singulair.

P.S. Merck Statement in Response to the FDA's June 12, 2009 Communication with Updated Information on Leukotriene Inhibitors, Including SINGULAIR® (montelukast sodium) -- June 12, 2009 press release from Merck & Co., Inc. (6/24/09)

Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report

2009-06-23T13:46:31-04:00

This Public Interest Group Reviewed Gardasil Cases Found In FDA’s Vaccine Adverse Event Reporting System (VAERS)

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to the Gardasil web site:

GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases.

On June 22, 2009 the public interest group Judicial Watch issued a press release regarding the Gardasil vaccine which had the following attention-getting headline and sub-headline:

New FDA Records Obtained by Judicial Watch Indicate 28 Deaths Related to Gardasil in 2008

View Discussion Records Document 6,723 Adverse Reactions in 2008, Including 1,061 Considered "Serious" and 142 Considered "Life Threatening"

According to this June 22 press release Judicial Watch is basing their numbers on the group's review of the FDA’s Vaccine Adverse Event Reporting System (VAERS), during which they found:

...28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV), up from 19 deaths in 2007. The total number of Gardasil-related deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening."

The June 22, 2009 Judicial Watch press release has links to the VAERS case reports for some Gardasil adverse reactions that are cited as examples.

The press release closes with this "position statement" by Judicial Watch:

"The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied," said Judicial Watch President Tom Fitton. "The already serious problems associated with Gardasil seem to be getting worse. No one should require this vaccine for young children."

We would be interested in hearing about any Gardasil adverse reactions you know of, as well as your opinion about whether the Gardasil vaccine should be required for young children. To participate in this conversation, you only need to submit a Comment, below.

Relatively Little Is Known About Long-Term Safety Of Bisphosphonates Such As Fosamax, Boniva, Actonel

2009-06-19T15:29:00-04:00

Doctors Should Inform Their Patients About Potential Serious Side Effects Like Osteonecrosis Of The Jaw And Femur Fractures

(Posted by Tom Lamb at DrugInjuryWatch.com)

The rather alerting headline above comes from an article, "Osteoporosis treatments and adverse events", which was published in the April 30, 2009 edition of Current Opinion in Rheumatology.

From the Abstract for this medical journal article:

Osteoporosis treatments will be used with increasing frequency as the population ages; however, relatively little is known about their long-term safety. Recent case reports cite a range of potential adverse events. We review data regarding atrial fibrillation, bone pain, osteonecrosis of the jaw (ONJ), atypical fractures, and osteosarcoma....

Although case reports of adverse events with osteoporosis medications suggest potential links, epidemiological analyses have largely failed to illuminate a strong, clear link between osteoporosis therapies and many adverse events, with ONJ an exception. Until further data are available, providers should be aware of these potential side effects, and inform their patients accordingly.

Because there are growing number of patients who use bisphosphonates like Merck's very popular Fosamax pill, and due to the range of possible different side effects that have been associated with the use of those osteoporosis drugs, I thought it would be worthwhile to do a "round-up" of our recent posts on this subject.

More About A "New" Fosamax Bone Side Effect, Leg Fractures In Region Of Thigh Or Femur

March 2009 Drug Safety Update Article And BMJ Case Reports Item Bring Attention To Fosamax-Related Atypical Stress Fractures Or Insufficiency Fractures Of Femur

Fosamax Update January 2009: More Osteonecrosis Of Jaw Cases Reported In Medical Journal

Possible Link Between Fosamax And Esophagus Cancer Surfaces; Merck Disputes This New Side Effect

When Will FDA Report Its Findings About Any Link Between Fosamax And Atrial Fibrillation

In October 2007 The Agency Estimated It Would Need Up To 12 Months To Complete Investigation Regarding This Possible Bisphosphonate Side Effect

As regards to the numerous Fosamax lawsuits involving ONJ that have been filed against Merck, the first Fosamax trial is scheduled to start in August 2009 -- with many more trials in federal and state courts expected to follow.

We will continue to keep you informed about the medical and legal developments concerning serious side effects associated with bisphosphonates such as Fosamax, Boniva, Actonel, Aredia, and Zometa.

June 18 Congressional Subcommittee Meeting About Medical Device Safety Act of 2009

2009-06-17T13:39:18-04:00

This Bill, If Passed, Would Restore An Injured Patient's Right To Sue A Medical Device Manufacturer By Reversing Riegel v. Medtronic Ruling

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 18, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346).

This June 18 hearing has been titled "Medical Devices: Are Current Regulations Doing Enough for Patients?" It is my understanding that this hearing is intended to be a follow-up to the Health Subcommittee's May 12, 2009 hearing on H.R. 1346.

At this June 18 hearing I hope the idea of keeping medical device patients safe by maintaining "complementary" systems, i.e., the FDA and our civil court system, is stressed and understood. In order to insure that our medical devices are effective and safe we need both a rigorous FDA device-approval process and court access when a defective device harms a patient.

Unfortunately, as a result of the United State Supreme Court's decision in the Riegel v. Medtronic case -- which was handed down in the first part of 2008 -- injured patients are currently barred from going into the court system and holding medical device manufacturers legally accountable for an injury caused by a defective device, e.g., Sprint Fidelis lead wire malfunction victims.

From my perspective, this current situation is not fair to injured patients and that is why we need Congress to pass the Medical Device Safety Act of 2009 into law. Simply put, this bill would prevent medical device manufacturer from receiving total immunity as regards any patient injury claim simply by pointing to the FDA's prior approval of its device. Instead, if passed, the Medical Device Safety Act would allow an injured patient to recover legal compensation when her injury was caused by a defective medical device.

What do you think about this issue of whether the federal preemption doctrine should be applied so as to prevent injured patients from suing a medical device manufacturer?

Medication Errors Are One Of The Most Common Medical Mistakes, But Number Can Be Reduced

2009-06-16T17:17:00-04:00

Two Reports From April 2009 Medical Journal Offer Possible Solutions To A Problem Which Affects At Least 1.5 Million People Per Year

(Posted by Tom Lamb at DrugInjuryWatch.com)

The April 27, 2009 edition of the Archives of Internal Medicine included two articles by researchers who have suggested some ways by which hospitals and pharmacists could work to reduce the high annual number of medication errors in the U.S.

These two medical journal articles are:

"Effect of a Pharmacist on Adverse Drug Events and Medication Errors in Outpatients With Cardiovascular Disease" (Arch Intern Med. 2009;169(8):757-763); and,
"Effect of an Electronic Medication Reconciliation Application and Process Redesign on Potential Adverse Drug Events: A Cluster-Randomized Trial" (Arch Intern Med. 2009;169(8):771-780).

For more about these two articles we turn to an April 27, 2009 HealthDay News report, "Medication Errors Could Be Cut: Experts", which was published on the MedlinePlus web site (note: site had once stated "this news item will not be available after 07/26/09"):

In the first report, researchers led by Dr. Jeffrey L. Schnipper, of Brigham and Women's Hospital and Harvard Medical School, used a computer system to keep track of the medications patients were taking when they were admitted to the hospital and the medications they were taking when they were discharged.

"It turns out that we commit about 1.5 errors per patient either for the admissions orders in the hospital or, much more commonly, in the discharge orders, which is kind of appalling," Schnipper said. "These are errors with potential for patient harm. There are about three times as many errors without potential for patient harm."...

The problem of medication error starts when patients are asked what drug they are taking when they come into the hospital, Schnipper said. "Patients don't know what they are taking. You have got to carry your current accurate medication list in your wallet," he advised....

In a second report, a team led by Michael D. Murray, chair of the department of pharmaceutical policy and evaluative sciences at the University of North Carolina at Chapel Hill, found that among outpatients with high blood pressure, when pharmacists, doctors and patients communicate, medication errors decrease.

"By working closely with doctors and nurses, pharmacists can help people avoid problems with their medication for chronic diseases like high blood pressure and heart failure," Murray said. "This has favorable effects on health and health-care costs."...

"This study shows the importance of having a pharmacist actively involved in asking about how the patient is doing, what type of side effects is the patient having, and is the patients taking the medication," Grissinger said. "That is as important as the initial consultation."

We have reported previously about the various aspects of medication errors and what might be done in terms of prevention. We are encouraged by these two recent medical journal articles that progress can and will be made in reducing the high number of these medical mistakes involving patients in the U.S. healthcare system.

Have Yasmin-Related Blood Clot Side Effect Cases Flown Below Radar In US?

2009-06-11T16:58:37-04:00

In Europe Reports Of Pulmonary Embolism And Deep Vein Thrombosis Were Made Soon After Yasmin Birth Control Pill Was Approved In 2000

(Posted by Tom Lamb at DrugInjuryWatch.com)

An April 13, 2002 BMJ article, "Dutch GPs warned against new contraceptive pill" (FREE registration required), was published the week before the Yasmin birth control pill was going to become available to women in the United Kingdom. From that article we learn, now, that Yasmin was the subject of safety concerns right from the start in Europe:

Dutch GPs are being advised by their own professional body not to prescribe a new low dose, monophasic oral contraceptive, marketed under the trade name Yasmin, until studies have established whether it is as safe as other contraceptive pills.

The new contraceptive, which is a combination of drospirenone (a progestogen) and ethinylestradiol, has been available in several European countries since 2000 and was approved by the US Food and Drug Administration last May. It is licensed for use in the United Kingdom, where it is being launched next week.

Last year a 17 year old Dutch girl who had been taking Yasmin died from a venous thrombosis. Although no direct link with Yasmin has ever been shown, 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal, have now been reported in Europe.

The Dutch College of General Practitioners has now reiterated its position that GPs should continue to choose the second generation pill, because of the lack of epidemiological data on the risk of thrombosis from Yasmin.

About a year later, in the February 1, 2003 edition of BMJ, there appeared a brief Drug Points piece, "Thromboembolism associated with the new contraceptive Yasmin", which provided some details about several cases of serious blood clot side effects in women using the Yasmin birth control pill.

Our centre, the Dutch spontaneous reporting system for adverse drug reactions, recently received five reports of thromboembolism as a suspected adverse drug reaction to the new oral contraceptive Yasmin (ethinylestradiol and drospirenone).

A 17 year old woman suddenly collapsed and died after taking the contraceptive [pill Yasmin] for six months. Autopsy showed that she had had a massive pulmonary embolism [(PE)]. No obvious risk factors for thromboembolism, such as smoking, a period of long immobilisation, air flights, or concomitant medication, were evident....

A 28 year old woman changed her oral contraceptive from ethinylestradiol with desogestrel (Marvelon) to ethinylestradiol with drospirenone [(Yasmin)]. Four months later she had thrombosis in one leg and was treated with acenocoumarol. Risk factors or concomitant drugs were unknown.

Another patient, a 45 year old woman, had deep vein thrombosis [(DVT)] in one leg after taking ethinylestradiol with drospirenone [(Yasmin)] for two months, as did a 50 year old woman who took the contraceptive for three months.

A 35 year old woman had pulmonary thrombosis 17 days after she started taking the contraceptive [pill Yasmin]. She had given birth four months earlier.

Only recently in the U.S. have there been products liability lawsuits filed on behalf of women who have developed a pulmonary embolism (PE) or deep vein thrombosis (DVT) after they used Yasmin -- or YAZ, a newer but very similar birth control pill that also contains the so-called "fourth generation" progestin drospirenone (DRSP).

We expect, however, to see an increasing number of Yasmin lawsuits -- and YAZ lawsuits -- as more women learn about the blood clot side effect risks associated with these "fourth generation" oral contraceptives only after they suffered a pulmonary embolism (PE) or a deep vein thrombosis (DVT).