Myocardial infarction symptoms and conditions

Does anyone know if Singulair can cause heart valve problems? I just found out that I have Mitral Valve Prolapse, and have never had any problems until after taking Singulair. Any info would be greatly appreciated...especially from Concerned Citizen if he's out there...

Thanks,

K.

As a fairly healthy 34 year old male, I went to my doctor for help getting over poison ivy mid-July 2008. I received the Kenalog 40 injection without being advised on any potential side effects. Within 36 hours I started having severe anxiety attacks with spikes in my blood pressure and vision problems (spotty, increased sensitivity to light). These attacks continued for 4-8 weeks during which time I underwent an MRI (head), stress test, and blood work to make sure nothing else was causing my symptoms.....conclusion: everything normal. My doctor prescribed me Xanax to help with the out of control anxiety. Started feeling more normal 60-90 days later. I started trying to run on my treadmill to get back in shape at the 90 day mark, and once again....symptoms returned. It's been a couple of weeks and I'm getting closer to being back to "normal", but I have no idea how long it will be before the Kenalog has completely metabolized out of my system, and I can get on with life. This has been a horrible experience and I would caution anyone from receiving this drug!

I have had mirena since April of 2008. It took me this long but I decided to check out if there were side effects posted from people because I, like others have had almost the exact same symptoms of everyone who has posted here. I have been taking vicodin for the migraines, been depressed, have horrible acne (especially on my back which I have never had before!), very painful intercourse (actually started crying once because it was that bad!) bled for like 4 months and now I bleed like forever when I do get my period, which is still every month, and it is kinda like spotting but enough that I can't have sex! I even went to the hospital one night because the cramping was so bad! They did ultrasounds and everything and told me everything was fine. I, like many others, have been waiting for all these symptoms to go away! I think I will consider getting it removed at this point. And oh yeah, lately I have experienced alot of discharge and it kinda has a weird odor, not a yeast infection- I tested, and no symptoms with peeing so prolly not a bladder thing and def not an std-been with same partner for 6 years! What do I do!

Below is the latest ADR report on Singulair from the United Kingdom. I deleted side effects reports by very small numbers of patients in order to keep the post briefer. This shows the total number of reports since Singulair was approved in the UK.

I don't know the total number of prescriptions for Singulair in the UK. It is considered expensive.

Drug Analysis Print
Drug name: MONTELUKAST
Drug name: MONTELUKAST Report type: Spontaneous
Report run date: 13-May-2008 Report origin: UNITED KINGDOM
Data lock date: 09-May-2008 08:00:02 PM Route of admin: ALL
Period covered: 01-Jul-1963 to 09-May-2008 Reporter type: ALL
Earliest reaction date: 01-Jan-1997 Reaction: ALL

Cardiac disorders-TOTAL 64
Palpitations 29
Myocardial infarction 6
Tachycardia 6
Diarrhoea 84
Dyspepsia 24
Abdominal pain 98
Abdominal pain upper 22
Nausea 84
Vomiting 52
Dry mouth 15
Asthenia 13
Fatigue 45
Malaise 32
Sudden death 1
Pyrexia 10
Chest discomfort 12
Feeling abnormal 16
Influenza like illness 17
Irritability 18
Drug interaction 13
Chest pain 13
Arthralgia 59
Myalgia 38
Muscle spasms 24
Pain in extremity 14
Balance disorder 10
Lethargy 16
Somnolence 23
Psychomotor hyperactivity 25
Headache 221
Dizziness 68
Neuropathy peripheral 7
Convulsion 6
Epilepsy 7
Dysgeusia 7
Hypoaesthesia 6
Tremor 18
Nervous system disorders TOTAL 526
Abnormal behaviour 13
Agitation 12
Anxiety 18
Aggression 30
Depression 23
Insomnia 58
Abnormal dreams 12
Nightmare 49
Hallucination 21
Sleep disorder 15
Psychiatric disorders TOTAL 364
Asthma 36
Allergic granulomatous angiitis 43
Angioedema 12
Swelling face 12
Erythema 13
Pruritus 32
Rash pruritic 17
Rash 55
Urticaria 33

TOTAL NUMBER OF REACTIONS 2841
TOTAL NUMBER OF FATAL ADR REPORTS* 19
TOTAL NUMBER OF ADR REPORTS* 1489

The example that I am posting below is not the only patent for an aminoquinoline derivative that is proposed for the treatment of neuro-psychiatric disorders. Even though we are not comparing exact chemical structures, it is certainly worth considering how the quinolines relate to this receptor.

It is also worth considering why montelukast, a quinoline, seems to be causing some of the problems that this owners of this particular patent think that they can treat.

As I mentioned before, I have no answers. Regardless of how small Merck believes the population of Singulair patients who suffer neuro-psychiatric disorders is, I do not believe that any patient should be ignored. It also seems that many companies have studied this area in depth and more than one company knows a lot more than we know about why it is possible for these side effects to happen.

" The compounds of formula I have a good activity on the 5-HT.sub.5A receptor. Therefore, the invention further provides methods for the treatment of depression (which term includes bipolar depression, unipolar depression, single or recurrent major depressive episodes with or without psychotic features, catatonic features, melancholic features, atypical features or postpartum onset, seasonal affective disorders and dysthymia, depressive disorders resulting from a general medical condition including, but not limited to, myocardial infarction, diabetes, miscarriage or abortion), anxiety disorders, (which includes generalized anxiety and social anxiety disorder, panic disorders, agoraphobia, social phobia, obsessive compulsive disorders, post-traumatic stress disorders, psychotic disorders (which includes schizophrenia, schizoaffective disorders, bipolar disease, mania, psychotic depression, and other psychoses involving paranoia and delusions), pain (particularly neuropathic pain), memory disorders (including dementia, amnesic disorders and age-associated memory impairment), disorders of eating behaviors (including nervosa and bulimia nervosa), sexual dysfunction, sleep disorders (including disturbances of circadian rhythm, dyssomnia, insomnia, sleep apnea and narcolepsy), withdrawal from abuse of drugs (such as of cocaine, ethanol, nicotine, benzodiazepines, alcohol, caffeine, phencyclidine and phencyclidine-like compounds, opiates such as cannabis, heroin, morphine, sedative hypnotic, amphetamine or amphetamine-related drugs), motor disorders such as Parkinson's disease, dementia in Parkinson's disease, neuroleptic-induced Parkinsonism and tardive dyskinesias, as well as other psychiatric disorders and gastrointestinal disorders such as irritable bowel syndrome (WO 2004/096771). "

******

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service Food and Drug Administration
Rockville, MD 20857
TRANSMITTED BY FACSIMILE

Nancy Konnerth
Associate Director,
Advertising and Labeling
Drug Regulatory Affairs
Berlex Laboratories
340 Changebridge Road P.O. Box 1000 Montville,
NJ 07045-1000

RE: NDA 21-098 Yasmin (drospirenone/ethinyl estradiol) Tablets
MACMIS ID# 11730

Dear Ms. Konnerth:

This letter notifies Berlex Laboratories (Berlex) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct-to-consumer (DTC) broadcast advertisement (TV ad) for Yasmin (drospirenone/ethinyl estradiol) Tablets that is misleading and in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable implementing regulations. Specifically, the 60-second TV ad entitled "Goodbye Kiss" is misleading because it makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives. As a result, the TV ad raises significant public health and safety concerns. Background Yasmin is a combination oral contraceptive ("COC" or "birth control pill") prescription drug product. Yasmin, like any oral contraceptive, is associated with increased risks of several serious conditions (including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension), although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.

The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. (See the WARNINGS section of the Yasmin approved physician labeling (PI)) Yasmin contains the estrogen ethinyl estradiol and the progestin drospirenone. Drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. This additional risk is described in the Bolded Warning of Yasmin's PI: Nancy Konnerth. 2 Berlex Laboratories NDA 21-098 Yasmin contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in highrisk patients, comparable to a 25 mg dose of spironolactone . Yasmin should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium, should have their serum potassium level checked during the first treatment cycle. Drugs that may increase serum potassium include ACE inhibitors, angiotensin -- II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists, and NSAIDs.

Consequently, Yasmin can exacerbate serious heart and health problems, in addition to the potential problems common to all COCs. Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs. Therefore, these women and their healthcare providers must weigh Yasmin's additional health risks when considering Yasmin over COCs without drospirenone. Misleading Efficacy and Safety Presentations Prescription drug ads are false or misleading if they contain a drug comparison that represents or suggests that a prescription drug is more effective or safer than another drug when it has not been demonstrated to be safer or more effective by substantial evidence or substantial clinical experience (21 CFR 202.1(e)(6)(ii)). The TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by the tagline "Ask about Yasmin, and the difference a little chemistry can make" (emphasis added) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This "chemistry" difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone as communicated in the Warnings/Bolded Warning, and Precautions/Drug Interactions sections of the PI.

Specifically, the following claims in the TV ad address Yasmin's efficacy: "You don't settle when it comes to the guy...so why settle when it comes to the pill? The Yasmin birth control pill uses a different kind of hormone. One that may work with your body chemistry. Yasmin is over 99% effective at preventing pregnancy. So when you're looking for the right pill, ask your doctor about the difference a little chemistry can make." (emphasis added) These claims are misleading because they suggest that Yasmin's "different kind of hormone" offers unique "chemistry" benefits and that this difference contributes to the high rate of drug efficacy. Moreover, these claims are misleading because they imply superiority to other COCs (and thus do not offer the same product benefits as Yasmin Tablets) when such has not been demonstrated by substantial evidence or substantial clinical experience. Finally, these claims are misleading because they misrepresent Yasmin's mechanism of action by stating that Yasmin "uses a different kind of hormone. One that may work with your body Nancy Konnerth. 3 Berlex Laboratories NDA 21-098 chemistry." However, COCs, including Yasmin, prevent ovulation by working against the usual body chemistry of a woman of childbearing potential by suppressing endogenous gonadotropins and, thereby, inhibiting ovulation and altering other changes associated with the menstrual cycle.

In addition, the statement "Yasmin contains a different progestin, which may increase potassium" is misleading because the "may increase potassium" disclosure fails to communicate that the potential to increase potassium is a risk. Furthermore, consumers may interpret the statement as a product benefit claim rather than a risk disclosure due to the overall positive message that Yasmin's "chemistry" is a product benefit. The ad conveys this positive message to consumers, notwithstanding the disclosure that "You should not take Yasmin if you have kidney, liver, or adrenal disease," because the "different kind of hormone" and "chemistry'" messages are never clearly identified as potentially leading to increased potassium levels or that increased serum potassium can be dangerous. This important risk information is in a Bolded Warning in the PI and clearly conveyed in the Yasmin Brief Summary Patient Package Insert and in the Detailed Patient Package Insert: Yasmin is different from other birth-control pills because it contains the progestin drospirenone. Drospirenone may increase potassium. Therefore, you should not take Yasmin if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Yasmin is right for you, and during the first month that you take Yasmin, you should have a blood test to check your potassium level. Thus, by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience. In summary, the TV ad not only misleads consumers about the efficacy of Yasmin, the ad also minimizes important context about the health risks of the drug. ]

Conclusions and Requested Actions
Berlex should immediately discontinue the TV ad and all other promotional materials and activities for Yasmin that contain the same or similar violative presentations. Berlex should submit a written response to DDMAC on or before July 24, 2003, describing its intent and plans to comply with the above. In its letter to DDMAC, Berlex should include the date on which these and other similarly violative materials were discontinued.

Berlex should direct its response to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857.

Nancy Konnerth. 4 Berlex Laboratories NDA 21-098 In all future correspondence on this matter, please refer to MACMIS ID# 11730 as well as the NDA number. DDMAC reminds Berlex that only written communications are considered official. Sincerely, {See appended electronic signature page} Joan Hankin Consumer Promotion Analyst Division of Drug Marketing, Advertising, and Communications

--------------------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. -------------------------------------------------------------------------------------------------------------------- /s/ --------------------Joan Hankin 7/10/03 03:40:53 PM

I have had 80% of the symptoms posted here all within 3 weeks of first taking Lisinopril.
I found this online...the manufacturers know what it cn do, but they make a lot of money from our suffering.

It read:
Lisinopril --In clinical trials adverse reactions which occurred with lisinopril were also seen with PRINZIDE. In addition, and since lisinopril has been marketed, the following adverse reactions have been reported with lisinopril and should be considered potential adverse reactions for PRINZIDE: Body as a Whole: Anaphylactoid reactions (see WARNINGS , Anaphylactoid and Possibly Related Reactions ), malaise, edema, facial edema, pain, pelvic pain, flank pain, chills; Cardiovascular: Cardiac arrest, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS , Hypotension), pulmonary embolism and infarction, worsening of heart failure, arrhythmias (including tachycardia, ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia, and premature ventricular contractions), angina pectoris, transient ischemic attacks, paroxysmal nocturnal dyspnea, decreased blood pressure, peripheral edema, vasculitis; Digestive: Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (see WARNINGS , Hepatic Failure ), gastritis, anorexia, flatulence, increased salivation; Endocrine: Diabetes mellitus; Hematologic: Rare cases of neutropenia, thrombocytopenia, and bone marrow depression have been reported. Hemolytic anemia has been reported; a causal relationship to lisinopril cannot be excluded; Metabolic: Gout, weight loss, dehydration, fluid overload, weight gain; Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, joint pain, leg pain, arm pain, lumbago; Nervous System/Psychiatric: Ataxia, memory impairment, tremor, insomnia, stroke, nervousness, confusion, peripheral neuropathy (e.g., paresthesia, dysesthesia), spasm, hypersomnia, irritability; Respiratory: Malignant lung neoplasms, hemoptysis, pulmonary edema, pulmonary infiltrates, eosinophilic pneumonitis, bronchospasm, asthma, pleural effusion, pneumonia, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngitis, rhinitis, rhinorrhea, chest sound abnormalities; Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema. Other severe skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported rarely; causal relationship has not been established; Speical Senses: Visual loss, diplopia, photophobia, taste disturbances; Urogenital: Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), pyelonephritis, dysuria, breast pain.

I had a myocardial infarction (sp) in 1998. Now 5 years later, after being prescribed 20 mg, then, 40 mg, then 60mg (break the 40 into 1/2), then finally up to 40 mg - twice daily,
I still had high BP and, over the years, the 5 years, felt like I was dying slowly. It was not controlling my BP so I insisted to my Doctor that we look at something else. I dropped the lisinopril and started on Lotrel 5 days ago... My BP has gone to normal and I feel like a new person. Why, oh why did i go through this for 5 years, unknowing what Prinovil/lisprinovil was doing to me. THis is just disgusting. I have been a waling zombie for the past five years, not knowing what a good life could be.