Lyrica Drug

Generic Name: pregabalin (pre GAB a lin)
Brand Names: Lyrica

What is Lyrica?

Lyrica (pregabalin) is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia).

Lyrica is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Lyrica also affects chemicals in the brain that send pain signals across the nervous system.

Lyrica may also be used for other purposes not listed in this medication guide.

Important information about Lyrica

You may have thoughts about suicide while taking Lyrica. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

If you are taking Lyrica to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking Lyrica. Follow your doctor's instructions.

Do not change your dose of Lyrica without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

If you stop taking Lyrica suddenly, your seizures may become worse or you may have withdrawal symptoms. Withdrawal symptoms include headache, sleep problems, nausea, and diarrhea. Do not stop using Lyrica suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Carry an ID card or wear a medical alert bracelet stating that you are taking Lyrica, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Before taking Lyrica

You should not use Lyrica if you are allergic to pregabalin.

Before using Lyrica, tell your doctor if you are allergic to any drugs, or if you have:

• congestive heart failure;

• diabetes; or

• kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Lyrica.

You may have thoughts about suicide while taking Lyrica. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use Lyrica without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 18 years old.

How should I take Lyrica?

Take Lyrica exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. You may take Lyrica with or without food.

Do not change your dose of Lyrica without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

If you are taking Lyrica to prevent seizures, keep taking it even if you feel fine. You may have an increase in seizures if you stop taking Lyrica. Follow your doctor's instructions. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Withdrawal symptoms include headache, sleep problems, nausea, and diarrhea. Do not stop using Lyrica suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Carry an ID card or wear a medical alert bracelet stating that you are taking this medication, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication. Store this medication at room temperature away from moisture, light, and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical treatment if you think you have used too much of this medicine.

Symptoms of a Lyrica overdose are not known.

What should I avoid while taking Lyrica?

Avoid drinking alcohol. It can increase some of the side effects of Lyrica. Lyrica can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Lyrica. Tell your doctor if you regularly use any of these other medicines.

Lyrica side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);

• easy bruising or bleeding; or

• swelling in your hands or feet, rapid weight gain.

Less serious side effects may include:

• dizziness or drowsiness, anxiety;

• blurred vision;

• loss of balance or coordination;

• problems with memory or concentration;

• dry mouth;

• skin rash or itching;

• constipation, stomach pain;

• increased appetite; or

• joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Lyrica side effects in more detail

What other drugs will affect Lyrica?

There may be other drugs that can interact with Lyrica. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Lyrica.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Abilify Durg uses

Generic Name: aripiprazole (AR i PIP ra zole)
Brand Names: Abilify, Abilify Discmelt

What is Abilify?

Abilify (aripiprazole) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adults.

Abilify is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.

Abilify may also be used for other purposes not listed in this medication guide.

Important information about Abilify

Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance. Abilify can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of Abilify.

Before you take aripiprazole, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.

What should I discuss with my healthcare provider before taking Abilify?

Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medicine if you are allergic to aripiprazole. If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Abilify:

• liver or kidney disease;

• heart disease, high blood pressure, heart rhythm problems;

• a history of heart attack or stroke;

• a history of low white blood cell (WBC) counts;

• a history of breast cancer;

• seizures or epilepsy;

• a personal or family history of diabetes; or

• trouble swallowing.

The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes. The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.

Abilify may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Abilify.

FDA pregnancy category C. It is not known whether Abilify is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Abilify can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Medical drugs

FDA Exclusive Enforcement, Lanham Act Division

The Ninth Circuit just issued a major decision reaffirming the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. See Photomedex, Inc. v. Irwin, No. 07-56672, slip op. (9th Cir. April 15, 2010).


First, an aside. Are we reading that number right? This is a 2007appeal? We’ve heard criticism that the Ninth Circuit has become too big and ponderous, but we never thought about it all that much – being on the opposite coast. Well, if the Ninth Circuit’s got a three-year appeal backlog, that’s just too much, and something really ought to be done to divide that court in half, or some other approach. Justice delayed is justice denied, and so on and so forth…. Is the Ninth Circuit simply to big to succeed?

But back to the main point.

We’ve gone on until we’re blue in the face about how 21 U.S.C. §337(a) represents express congressional policy that nobody but the government (that is, the Department of Justice or the FDA) can seek to enforce the Food, Drug and Cosmetic Act (“FDCA”) in a court of law. We’d list some posts, but there are, frankly, too many of them, so here’s the search results for “337(a).”

The no-private-right-of-action argument is especially important in dealing with negligence per se claims and the so-called “parallel violation” claims that are essentially the only avenue arguably left open to plaintiffs in Class III PMA medical device cases afterRiegel v. Medtronic, Inc., 552 U.S. 312 (2008).

But the issue also comes up in Lanham Act cases involving litigation between commercial competitors. Indeed, when Bexis first got the idea to put the §337(a) argument to work in the personal injury field over a decade ago in the Bone Screwlitigation, Lanham Act cases were the primary source of available precedent.

They continue to be valuable precedent today. Photomedexinvolved a dispute between competing manufacturers of different lasers used for treating skin diseases (psoriasis, etc.). The founder of the defendant company used to work for the plaintiff company, which no doubt added a bit of personal animosity to the mix. The plaintiff made the usual potpourri of claims, but the important one for our purposes was the Lanham Act claim that the defendants sought commercial advantage by misrepresenting that the FDA had cleared (lasers are not PMA devices) their competing laser. Photomedex, slip op. at 5544-45 (9th Circuit pagination is obviously unusual, as the first page here is 5539)

Because the Lanham Act is a federal statute, Photomedex, unlikeBuckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which involved state-law claims, there’s no preemption argument. But the flip side of preemption where exclusive FDA enforcement is concerned, is standing. The Court accepted that, in any kind of suit, §337(a) restricts the ability of a plaintiff to pursue a theory that turns on claimed FDCA violations:

Section 337(a) of the FDCA bars private enforcement of the statute, stating that “all such proceedings for the enforcement, or to restrain violations, of this [Act] shall be by and in the name of the United States.” The Supreme Court has observed that Section 337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Buckman, 531 U.S. at 349 n. 4.

The Supreme Court made clear in Buckman that this section also limits the ability of a private plaintiff to pursue claims under state law theories where such claims collide with the exclusive enforcement power of the federal government. Id. at 343, 349-50, 353 (holding that a state tort claim based on alleged fraudulent representations made by a medical device manufacturer in the course of seeking market approval from the FDA “would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme”).

Slip op. at 5547-47 (citations omitted). Where the FDA has not found a violation, no private party can assert that there is one. “Because the FDCA forbids private rights of action under that statute, a private action brought under the Lanham Act may not be pursued when, as here, the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.” Id. at 5548.

The Photomedex court carved out a familiar exception – that a flat out yes/no misrepresentation of FDA approval would escape §337(a). Id. (“an affirmative statement of approval by the FDA” where “no such FDA approval had been granted” may be pursued). But that sort of yes/no situation, where examination of the underlying regulatory scheme was unnecessary, wasn’t what happened in this case.

Rather, the plaintiff’s FDA approval (technically “clearance,” seeslip op. at 5550 n.3, distinguishing between “approval” and “clearance”) claim would have required a court to delve into the intricacies of the FDA’s “minor modification” rule. That is, it involved whether modifications to an already cleared device were sufficiently “major” to require the submission of a whole new §510k submission under 21 C.F.R. §807.81(a)(3). Slip op. at 5550-51. Whether the device that the defendant sold was a "major" modification of the device that the FDA had previously cleared could not be determined without examining the application of the FDA’s regulatory scheme to the facts:

It is significant that under the regulatory structure established by the FDA for the medical devices at issue in this case, clearance to market a given device did not necessarily require an affirmative statement of approval by the FDA. The FDA’s previous clearance of the [device that the defendant licensed] covered Defendants’ . . . device as well, as long as [it] was not significantly modified from the [prior] device.

Slip op. at 5551. Determining whether modifications were “minor” was “the responsibility in the first instance” of the device manufacturer. Id. Although the court doesn’t dig that far into the facts, presumably the defendant had the necessary minor modification memo in its files.

So the underlying legal dispute boiled down to the plaintiff claiming that the defendant’s device didn’t really have FDA clearance/approval because it wasn’t really a minor modification of the cleared product that the defendant had licensed. Slip op. at 5551-52. That sunk pretty far into FDCA minutiae, and (it seems to us obviously) would have required examination of whether the FDA would find a violation.

Indeed, the plaintiff more or less cut its own throat in this regard, as it actually filed some sort of “complaint” with the FDA that led to an FDA investigation of the issue. The defendant gave the FDA agent a copy of what we presume was its minor modification memo (although the court does not use this term), and the FDA closed its investigation without finding its violation. Slip op. at 5552-53. The significance of the plaintiff's actions did not escape the court's attention. “That [plaintiff] engaged in an extensive campaign to try to convince the FDA to act on [defendant’s] supposed misstatements and violations demonstrates that [plaintiff] understood that this subject fell within the FDA’s domain.” Id. at 5559.

Please note, we've only given a stripped down version of the facts, and the actual FDA proceedings, which included a supplemental submission seeking clearance of additional uses, were much more involved. See slip op. at 5552-54. All those details may be fodder for the FDA Law Blog, but from our perspective, they only make the rubble bounce. We’re only concerned with the proposition that private plaintiffs can’t enforce purported FDCA violations, a point that’s readily transferrable to the tort sandbox where we play.

What we like is this: “The statute assigns to the FDA the responsibility for taking enforcement action against Defendants.” Slip op. at 5554. And this: “[Plaintiff] is not permitted to circumvent the FDA’s exclusive enforcement authority by seeking to prove that Defendants violated the FDCA, when the FDA did not reach that conclusion.” Id. And this: “[I]t is impossible for [plaintiff] to prove that [defendant’s] device had not been cleared by the FDA when the FDA itself did not take that position.” Id.

As we said above, other Lanham Act cases have taken pretty much the same position – since before the Bone Screw litigation that began in the mid 1990s. The court in Photomedex cites a bunch of these cases: IQ Products Co. v. Pennzoil Products Co., 305 F.3d 368, 372-74 (5th Cir. 2002) (not an FDCA case); Dial A Car, Inc. v. Transportation, Inc., 82 F.3d 484, 488-90 (D.C. Cir. 1996) (not an FDCA case); Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 230-32 (3d Cir. 1990);Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 934 (C.D. Cal. 1996); Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 305-07 (C.D. Cal. 1996). See Slip op. at 5555-56.

Significantly, the Photomedex court discussed and distinguishedAlpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934 (8th Cir. 2005), which dealt with FDA-approved uses for animal feed additives. The court found that Alpharma was much more of a straight yes/no case on FDA approval, since in Alpharma “the FDA made it clear that there was no record of the defendant obtaining the FDA’s approval for the additional uses." Photomedex, slip op. at 5557.

If you want a bunch more cases – all of which involve the FDCA – see our prior post on “What To Do With Un-Preempted Fraud On The FDA Claims.” If you’re still not satisfied, you’ll just have to buy Bexis’ book, which discusses the Lanham Act precedent in §4.02[2] and footnotes literally dozens of cases (Bexis has always been funny that way). Anyway, we’re sure Bexis will be adding this one to his book, since the court concludes:

The FDCA explicitly says that enforcement power is reserved to the federal government. To permit [plaintiff] to proceed with a claim that Defendants violated this law when the FDA did not so determine would, in effect, permit [plaintiff] to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make. We therefore affirm the order of summary judgment for the claims based on Defendants’ statements that the [device] had FDA clearance.

Photomedex, slip op. at 5559.

Photomedex is the first time the Ninth Circuit has spoken on the issue of FDA enforcement exclusivity and itsl preclusive effect on private litigation of supposed violations. While the opinion did not discuss state law because the plaintiff conceded it couldn’t pursue its consumer fraud claims, slip op. at 5559 n.7, other plaintiffs have not been so reasonable. Thus, the recognition inPhotomedex of the §337(a) exclusivity will be extremely useful precedent against plaintiffs bringing negligence per se/"parallel violation" claims, as we’ve already discussed here, as well as against plaintiffs seeking to bring economic loss claims under federal statutes such as RICO, as we already discussed here.

So if you’re facing a claim of any sort – be it statutory or common law – where the guts of the plaintiff’s arguments are that your client somehow violated the FDCA, you’ll want to read, and probably want to cite, Photomedex.