Cherry Hill, New Jersey Personal Injury Lawyer - FDA & Prescription Drugs

Merck is Jerking Investors Around in Securities Fraud Case

Mike Ferrara — Mon, 30 Nov 2009 21:20:30 GMT

Today, lawyers for drug giant Merck, infamous maker of the blockbuster painkiller Vioxx, delivered oral arguments to the Supreme Court saying that their shareholders had waited too long to file securities lawsuits alleging that Merck had misrepresented the safety of Vioxx.

According to Merck’s attorneys, investors should have filed their suits earlier, since information suggesting Merck had committed securities fraud was widely available as early as 2001. (The suits were filed in 2003, just after the two-year statute of limitations had expired, attorneys claim.) Somewhat contradictorily, the attorneys also argue that investors never had enough information to make a case for securities fraud against the company.

At least some of the justices, thank goodness, were dubious.

"Companies can't have it both ways," Justice Anthony Kennedy told a lawyer for Merck.

Justice Stephen Breyer said Merck's position, in effect, would require plaintiffs to file lawsuits before they had enough evidence to back them up. "That doesn't make sense to me," he said. –Wall Street Journal

Vioxx was Merck’s biggest seller until it was withdrawn from the market in 2004 for causing thousands of strokes and heart attacks. Merck ended up settling with former Vioxx users for more than $4 billion.

Merck shareholders are now seeking billions in damages from the company for deliberately misleading them, by downplaying a clinically established connection between Vioxx and an increased risk of heart attack. This in turn caused shareholders to pay artificially high prices for Merck stock—a situation they want rectified.

The Supreme Court is expected to rule on this case by late June 2010. Merck deserves to go down; let’s all recognize these stalling tactics for what they are.

Originally posted at InjuryBoard by Mike Ferrara

Wyeth to Pay $6.3 Million in Damages for Prempro Connection to Breast Cancer

Camryn Hansen — Sun, 22 Nov 2009 20:40:43 GMT

This week, a Philadelphia jury ruled that drug giants Wyeth and Upjohn, both owned by Pfizer, are liable for at least $6.3 million in damages because their hormone replacement therapy drugs played a significant causal role an Illinois woman’s breast cancer.

The drugs, Wyeth’s Prempro and Pharmacia & Upjohn’s Provera, are used to treat menopause symptoms including hot flashes, night sweats and mood swings. Donna Kendall, 66, took them for 11 years before having to have a double mastectomy.

In 2002, when Prempro sales were more than $2 billion, a federal study found that women who used Prempro and similar drugs had an increased risk of breast cancer.

Nearly a year ago, we learned that Wyeth paid ghostwriters to produce fraudulent articles in medical journals praising Prempro. Wyeth also kept the ghostwriters’ role in the articles a secret from the medical journal editors and readers. Disturbingly, at least one Wyeth-sponsored positive article was published after the federal study citing Prempro as a breast cancer risk.

Juries are paying attention, and this is good.

In Kendall’s case, jurors concluded Wyeth and Upjohn officials failed to adequately warn Kendall’s doctors about the drugs’ cancer risks and that failure played a role in the physicians’ decision to prescribe the drugs.

The panel also found Wyeth’s and Upjohn’s conduct in marketing and selling the drugs was hiding health risks was “wanton and reckless.” That makes the companies open to a punitive-damage award under Pennsylvania law. –Bloomberg

Since 2006, Wyeth has lost six out of nine jury verdicts. Thus far, at least 34 cases involving Prempro are set for trial, and Wyeth has settled at least five cases over hormone replacement therapy drugs.

Originally posted at InjuryBoard by Camryn Hansen

First Paxil/Birth Defect Case Gets Major Win for the Plaintiff

Mike Ferrara — Sun, 18 Oct 2009 16:17:46 GMT

This week in Philadelphia, jurors ruled 10-2 that the drug company GlaxoSmithKline behaved negligently in connection with its antidepressant Paxil, which allegedly caused birth defects in a baby whose mother took it while pregnant.

The case is the first of about 600 similar lawsuits to go to trial, and the 10-2 ruling constitutes a big win for the plaintiff, Michelle David of Bensalem, whose son Lyam was born with heart problems that subsequently required a number of surgeries to correct.

The jury awarded David $2.5 million in compensatory damages, seeing a clear connection between Paxil and baby Lyam’s birth defects. It did not, however, award any punitive damages, finding that Glaxo’s behavior had not been “outrageous,” in that it had not deliberately ignored or covered up evidence that Paxil caused birth defects in order to better profit from drug sales.

According to the jury, Glaxo’s negligence revolved around its failure to adequately inform David’s doctor of the risk of birth defects associated with taking Paxil during pregnancy.

Glaxo apparently plans to appeal the ruling.

The process is like a battle where eventually the plaintiff "cries uncle" and drops the suit or the drug company agrees to settle, said Philadelphia plaintiffs' lawyer Tom Kline, who is handling some Paxil birth-defect cases.

Kline said last week's jury verdict was a strong win because birth defects were fairly common whether or not a pregnant woman takes a drug. That can make it hard to convince a jury that a product caused a birth defect, he said.

"The real hurdle is proving causation," said Kline, who has represented plaintiffs at trial in many cases involving birth defects. –Philadelphia Inquirer

The fact that causation was so overwhelmingly obvious, in this case, to the jurors sets a strong precedent for future cases involving Paxil’s relationship to birth defects.

Originally posted at InjuryBoard by Mike Ferrara

FDA Identifies 19 Potentially Dangerous Drugs on the Market

Mike Ferrara — Thu, 08 Oct 2009 21:52:19 GMT

As we know, drugs that are shown to be “safe” for public consumption through clinical trials sometimes prove dangerous when actually consumed by the public on a day-to-day basis. Expecting this, the FDA gathers adverse event reports on every approved drug on the market. When it spots a pattern of adverse events associated with a particular drug, it puts this drug under intense scrutiny. If the drug proves, after extensive testing, to be dangerous, the FDA may implement new regulations such as a change in labeling, use restrictions, or black box warnings. Occasionally, as was the case with Merck’s Vioxx, safety concerns will compel the FDA to remove the drug completely from the market.

Below is the most recent list of drugs currently under close scrutiny by the FDA.

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

Product Name: Active Ingredient (Trade)
or Product Class

Potential Signal of Serious Risk/New Safety Information

Additional Information

(as of September 24, 2009)

Apomorphine (Apokyn)

Psychiatric events

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Choriogonadotropin alfa (Ovidrel)

Anaphylactic reactions

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Clomiphene citrate (Clomid)

Visual disorders

FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.

Clozapine orally disintegrating tablet (FazaClo)

Deaths

This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.

Darifenacin (Enablex) and Solifenacin (Vesicare)

Angioedema and other allergic reactions

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Drospirenone/ethinyl estradiol (Yasmin)

Pancreatitis

FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.

Efavirenz (Sustiva)

Birth defects involving the eye and face

This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case.
Efavirenz (Sustiva) labeling

Fibrin sealant, human (Evicel)

Air embolism

FDA is evaluating this issue to determine if labeling is adequate.

Hydrochlorothiazide in combination products

Skin reactions

FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.

Imiquimod cream (Aldara)

Dysuria due to severe local reactions during use in the genital area

This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24).

The labeling will be updated to include this event.

Modafinil (Provigil) and Armodafinil (Nuvigil)

Serious skin reactions

This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions.

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Orlistat (Xenical, Alli)

Hepatotoxicity

FDA issued an Early Communication about an Ongoing Safety Review on this issue in August 2009.

Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)

Polyethylene glycol oral laxative (various trade names)

Neuropsychiatric events

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Raltegravir (Isentress)

Psychiatric events

The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.
Raltegravir (Isentress) labeling

Selegiline (Emsam)

Hypertension

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Sumatriptan/naproxen (Treximet)

Myocardial infarction

FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.

Testosterone gel (Androgel, Testim)

Adverse events from accidental exposure

May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.

Tolterodine tartrate (Detrol)

Stevens-Johnson syndrome

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Varenicline (Chantix)

Angioedema, serious skin reactions, visual impairment, accidental injury

In July 2009, FDA approved revised labeling (changes to Precautions and Adverse Reactions sections and changes to the Medication Guide) to include angioedema, serious skin reactions, and accidental injury.
Varenicline (Chantix) Labeling (PDF - 285KB)

-FDA website

If you are taking any of the above drugs and are concerned about its potential adverse effects, please contact your health care provider right away.

Originally posted at InjuryBoard by Mike Ferrara

Merck Sued for Underhanded Marketing by Kentucky Attorney General

Mike Ferrara — Thu, 01 Oct 2009 23:29:42 GMT

Kentucky Attorney General Jack Conway has filed suit in Franklin Circuit Court against pharma giant Merck for violating Kentucky's Consumer Protection Act in connection with Vioxx, the blockbuster painkiller that caused strokes and heart attacks, and was withdrawn from the market in September 2004.

The lawsuit against Merck alleges that beginning May 1999, the company launched an aggressive, deceptive Vioxx marketing campaign targeting health care professionals as well as consumers. The campaign, which touted Vioxx’s effectiveness in treating osteoarthritis, menstrual pain, and other forms of acute pain, didn’t include an increased risk of cardiovascular events such as heart attacks and strokes in its list of common side effects, even though Merck knew full well about this risk.

The suit also accuses Merck of commissioning ghostwriters to write and researchers to forge their names on purportedly “scholarly” articles (published in reputable journals including The Journal of the American Medical Association) whose true purpose was to further develop Vioxx’s name recognition and credibility.

Merck was aware of the potential for dangerous cardiovascular side effects, including heart attack and stroke, associated with Vioxx through internal studies, including Study 090, which was conducted in 1998. The results of Study 090 were not disclosed to the FDA or the public at the time Vioxx was introduced to the public.

"Consumers have a right to know all of the risks associated with the prescription drugs they take," said General Conway. "Merck relied on an aggressive marketing campaign to lure consumers into taking Vioxx and then concealed the increased health risks associated with the drug. This kind of deception puts consumers at risk and will not be tolerated in Kentucky." -Office of Attorney General

Merck carried out their incredibly successful Vioxx campaign in Kentucky for more than five years, all the while representing this dangerous drug as a “safer” and more effective alternative to more commonly prescribed non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin and ibuprofen.

Just a few years ago, Vioxx was all the rage with doctors, hospitals, and patients all over the country. Now, it’s off the market and Merck is paying out nearly $5 billion in lawsuits for the strokes and heart attacks it negligently, greedily caused. The way Merck is now aggressively marketing its HPV vaccine Gardasil to America’s young people (before adequate testing has been performed) feels frighteningly similar to the way it handled Vioxx. Please read more about Gardasil’s adverse effects (and Merck’s blockbuster ad campaigns) if you are considering getting vaccinated or vaccinating your child.

Originally posted at InjuryBoard by Mike Ferrara

Before You Vaccinate with Gardasil, Know the Serious Risks

Mike Ferrara — Sat, 26 Sep 2009 12:57:20 GMT

If you are considering vaccinating your daughter with the increasingly popular Merck vaccine Gardasil, designed to protect against cervical cancer by preventing the sexually transmitted virus HPV, consider the following first:

Merck’s marketing for this vaccine has been one of the most aggressive in pharmaceutical marketing history, targeting not only the consumer population but doctors, researchers and even politicians. For the overwhelming success of its Gardasil campaign, Merck took home all of the 2008 Pharmaceutical Advertising and Marketing Excellence awards, and Pharmaceutical Executive Magazine named Gardasil its Brand of the Year.

The FDA was suspiciously eager to approve and recommend Gardasil. Unlike other vaccines, which usually take three years to be FDA-approved after the conclusion of clinical testing, Gardasil sped through the system in a mere six months. With similar alacrity, only a few weeks after FDA approval, the CDC recommended Gardasil for universal use among girls. Typically, it takes vaccines from 5 to 10 years to achieve this kind of universal status.

Typically, the grace period between the time a vaccine enters the market and the time it is universally adopted allows for adverse reactions, side-effects and other problems to be found before they have an impact on a huge population. Gardasil has not had this grace period. As of June 1, 2009, 25 million doses of the vaccine have been distributed in the United States. As of this date, there have also been 14,072 official reports of adverse events occurring after Gardasil vaccination in the United States. Ninety three percent were not serious, and ranged from arm pain to fainting, but seven percent were extremely serious, and included paralysis, blood clots, and more than 40 deaths (26 of which have been confirmed).

The worst reactions, as well as any and all long-term complications, may be still to come. Because the duration of Gardasil clinical trials was only five years, it is also not clear how long the vaccine offers protection against some strains of HPV. (It only offers 70% protection against HPV at full strength to begin with.) Some of Merck’s own clinical trials suggested that HPV protection wears off in some girls as early as three years after receiving Gardasil…which will probably translate into the need for girls and women to get booster shots every few years, ad infinitum.

The available information on this vaccine’s adverse effects strongly suggests that the FDA and CDC need to curb this frightening Gardasil free-for-all and re-evaluate its safety, both in the short term and in the long term.

Readers, if you have had any personal experiences with Gardasil’s negative effects, please share them here! People have to know about this vaccine’s risks before exposing their children to it.

Originally posted at InjuryBoard by Mike Ferrara

Eli Lilly Settles Seven State Suits (Confidentially) for Zyprexa Off-Label Marketing

Camryn Hansen — Wed, 23 Sep 2009 21:36:05 GMT

Earlier this week, Eli Lilly agreed to settle lawsuits filed by seven states, charging the pharmaceutical company with off-label marketing of the strong antipsychotic drug Zyprexa.

The terms of the settlements are to remain confidential, so we don’t know how much the company settled for with any of the states. If approved by the court, the settlements would leave only four pending state suits against Eli Lilly.

Zyprexa, Lilly’s best-selling drug, has been the subject of federal and state investigations into whether the company marketed the medicine, approved for schizophrenia and [severe] bipolar disorder, for unapproved, or off-label, uses. Lilly resolved a marketing investigation in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states.

The federal settlement left pending 12 lawsuits brought by individual states. Lilly announced July 22 that it would take a pretax charge of $102 million this quarter for settling “several” state lawsuits over Zyprexa. The company last month filed a $22.5 million settlement with West Virginia. -Bloomberg.com

Off-label marketing strategies for Zyprexa included encouraging doctors to prescribe the drug to patients with anxiety, age-related dimentia, and mild bipolar disorder, despite Zyprexa’s link to serious side effects including excessive weight gain and diabetes.

Lawsuits against Eli Lilly also claim that the company has consistently failed to warn doctors and patients of the drug’s side effects. Internal Eli Lilly documents have shown that the drugmaker ignored strong evidence of the Zyprexa-diabetes link while pushing the antipsychotic for off-label use.

Originally posted at InjuryBoard by Camryn Hansen

Phenergan Gets Black Box Warning from the FDA

Camryn Hansen — Mon, 21 Sep 2009 20:09:37 GMT

One woman’s horrific experience with Phenergan, the migraine drug formerly sold by Wyeth, has finally ended in a black box label—the strongest warning offered by the FDA—on the drug.

When in April of 2000, violinist Diana Levine went to her local health center seeking migraine treatment, a physician’s assistant administered Phenergan intravenously via the IV push method. But because the syringe missed Levine’s vein, the arm became gangrenous in a couple of weeks, and ultimately had to be amputated.

Levine sued Wyeth in Vermont State court, but the case was taken all the way to the US Supreme Court. Ultimately, the question the Court had to decide was whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method (more than 50 patients have developed gangrene as a result of using this specific method with Phenergan), and nevertheless marketed the drug to be used this way.

The Supreme Court sided with Levine, rejecting Wyeth’s arguments in favor of federal preemption and awarding the plaintiff $6.7 million in damages. Until last week, however, the FDA didn’t respond by placing any more regulations on Phenergan, also known as promethazine.

Now, promethazine will carry a black box label warning physicians that the safest way to administer the drug is through intramuscular injection (not IV push).

While it would have been gratifying to see the FDA ban the IV push method altogether with this drug, as Levine has indicated herself, the black box warning is nevertheless a win for consumer protections.

Originally posted at InjuryBoard by Camryn Hansen

AstraZeneca’s Ongluza: Here to Treat Diabetes Caused by Seroquel.

Camryn Hansen — Fri, 07 Aug 2009 22:10:17 GMT

It’s beyond fishy that drug giant AstraZeneca has partnered with Bristol-Myers Squibb to create Ongluza, the new diabetes drug that, now armed with FDA approval, stands to become a billion dollar blockbuster, competing directly with Merck’s Januvia.

Just a few months ago, AstraZeneca was in a lot of trouble for burying company documents that linked its popular antipsychotic, Seroquel, to the development of diabetes in patients taking the drug.

Seroquel, which brought in a full 14% of drug maker AstraZeneca’s $31.6 billion in sales last year, is only FDA-approved to treat schizophrenia and bipolar disorder. In the past few years, however, illegal off-label marketing for uses such as depression, insomnia, and childhood ADHD has spread its use 22 million patients, making it one of the best-selling drugs in the world.

More than 15,000 of these 22 million have filed over 9,000 personal injury lawsuits alleging not only that Seroquel caused them to develop diabetes, weight gain and other health problems, but that AstraZeneca knew as early as 2000 of Seroquel’s health risks and deliberately withheld these risks from patients and doctors.

As of July 2009, AstraZeneca had spent nearly $600 million fighting Seroquel-related lawsuits, fully exhausting its insurance coverage for such expenses.

Given the Ongluza development, it appears that AstraZeneca’s strategy will be to continue to market Seroquel for off-label uses to as many Americans as possible, and when this drug gives them diabetes, pay for the lawsuits by selling them some Ongluza to treat it.

Originally posted at InjuryBoard by Camryn Hansen

FDA Advisers: Vicodin and Percocet Belong off the Market

Camryn Hansen — Wed, 01 Jul 2009 23:29:29 GMT

Yesterday, an FDA advisory panel voted to recommend that all drugs combining acetaminophen (commonly known as Tylenol) with narcotics be taken off the market due to their elevated risk for severe liver damage and overdose.

Combination drugs like these include Vicodin and Percocet—two prescription painkillers that can be addictive and are sometimes sold on the street. If the FDA does not remove these drugs from circulation, the panel said, it should reduce the amount of acetaminophen in them and make sure patients fully understand the risk of liver damage associated with taking them.

The group recommended that the FDA "send a clear message that there's a high likelihood of overdose from prescription narcotics and acetaminophen products," Dr. Sandra L. Kweder of the FDA's Office of New Drugs said at a news conference after Tuesday's meeting.

Although acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.

The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year. -CNN

Following up on earlier recommendations, the panel also recommended that to prevent overdose and consequent liver damage, the FDA should lower the maximum daily dose of acetaminophen in OTC and prescription medications as well as pay more attention to doses of the drug in children’s medicines.

Though the FDA doesn’t have to follow advisory committee recommendations like these, it usually does.

As a consumer, please pay attention to the ingredients in your medications. Whenever you take an over-the-counter product containing acetaminophen, make sure that you are not taking more than the recommended dose, and supervise children’s dosages vigilantly. Just because you can get a drug over the counter does not mean that it’s safe.

Originally posted at InjuryBoard by Camryn Hansen

Product Name: Active Ingredient (Trade) or Product Class	Potential Signal of Serious Risk/New Safety Information	Additional Information (as of September 24, 2009)
Apomorphine (Apokyn)	Psychiatric events	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Choriogonadotropin alfa (Ovidrel)	Anaphylactic reactions	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Clomiphene citrate (Clomid)	Visual disorders	FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.
Clozapine orally disintegrating tablet (FazaClo)	Deaths	This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.
Darifenacin (Enablex) and Solifenacin (Vesicare)	Angioedema and other allergic reactions	FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Drospirenone/ethinyl estradiol (Yasmin)	Pancreatitis	FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.
Efavirenz (Sustiva)	Birth defects involving the eye and face	This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case. Efavirenz (Sustiva) labeling
Fibrin sealant, human (Evicel)	Air embolism	FDA is evaluating this issue to determine if labeling is adequate.
Hydrochlorothiazide in combination products	Skin reactions	FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.
Imiquimod cream (Aldara)	Dysuria due to severe local reactions during use in the genital area	This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24). The labeling will be updated to include this event.
Modafinil (Provigil) and Armodafinil (Nuvigil)	Serious skin reactions	This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions. FDA is continuing to evaluate this issue to determine the need for any further regulatory action.
Orlistat (Xenical, Alli)	Hepatotoxicity	FDA issued an Early Communication about an Ongoing Safety Review on this issue in August 2009. Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)
Polyethylene glycol oral laxative (various trade names)	Neuropsychiatric events	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Raltegravir (Isentress)	Psychiatric events	The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events. Raltegravir (Isentress) labeling
Selegiline (Emsam)	Hypertension	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Sumatriptan/naproxen (Treximet)	Myocardial infarction	FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.
Testosterone gel (Androgel, Testim)	Adverse events from accidental exposure	May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.
Tolterodine tartrate (Detrol)	Stevens-Johnson syndrome	FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Varenicline (Chantix)	Angioedema, serious skin reactions, visual impairment, accidental injury	In July 2009, FDA approved revised labeling (changes to Precautions and Adverse Reactions sections and changes to the Medication Guide) to include angioedema, serious skin reactions, and accidental injury. Varenicline (Chantix) Labeling (PDF - 285KB)