ADR database

ADR DATABASE

References:
Br J Psychiatry 1995; 167: 374-379
BMJ 1998; 316: 1105-1106
Reviewed: 02/1999

Paroxetine (antidepressant)
Discontinuation reactions

A double blind, placebo controlled study, showed that in the two weeks after a 12 week treatment period adverse events occurred in 35% of patients (with panic disorder) treated with paroxetine compared with 14% of controls.
Adverse events were mostly mild or moderate.
The incidence of discontinuance reactions is common with antidepressant, and is higher after abrupt termination and longer courses of treatment.
Discontinuation symptoms do not in themselves indicate drug dependence.

References:

Clin Drug Invest 1998; 15: 61-63
Reviewed: 06/1998

Penicillamine (chelating agent)
Progression of scleroderma

A 58-Year old patient with recent sclerodactyly + Raynaud's phenomenon, developed a rapidly progressive skin thickening, followed by acute renal failure four months later as a consequence of a haemolytic-uraemic syndrome, after a treatment with penicillamine and prednisone.

References:

Am J Cardiol 1998;81(4): 523
Reviewed: 06/1998

Perindopril (antihypertensive)
Lingual angioedema

A case of severe lingual oedema and airway compromise was reported with perindopril, as a syndrome of angioedema. This kind of reaction is known to occur with all ACE-inhibitors.

References:

Info Fran Lakemedelsverket 1997; 4
Reviewed: 04/1998

Pertussis vaccine (vaccine)
Pharmacovigilance data

After the first-year use in Sweden of a combined pertussis vaccine (Infanrix â), there were 89 reports of adverse reactions, mainly fever, skin reactions, or hypotonic-hyporesponsive episodes; seldom restlessness, pain, cramps, and two cases of muscle hypotonia.

References:

Australian ADR Bulletin 1997; 16: 10
Reviewed: 04/1998

Pethidine (opioid analgesic)
Convulsions

35 reports of convulsions with pethidine, sometimes in combination with other drugs, were received in Australia since 1975.

References:

Wyeth Ayerst; June 26, 1998
Reviewed: 07/1998

Phendimetrazine (anorexigen)
Warnings

Warnings of possible valvular irregularities and primary pulmonary hypertension with phendimetrazine were issued by the manufacturer. Primary pulmonary hypertension - a rare, but frequently fatal disease - has been found to occur with increased frequency in patients receiving anorexigens.

References:

WHO Drug Information 1997; 11(4): 251-52
Reviewed: 04/1998

Phenolphtalein (laxative)
Carcinogenicity

Phenolphtalein laxatives were proposed for a ban on the OTC market in the USA, after a review of its carcinogenicity studies in rodents and mice. The doses that produced cancer were 30 -100 times higher than the recommended dose in humans.

References:

WHO Pharmaceutical Newsletter N° 3-4, 1997
Reviewed: 12/1997

Pimozide (antipsychotic)
Interactions with antibiotics

The labelling for the antipsichotic pimozide (pimozide, DC.IT.) has been revised in the USA to include the contraindication of its use in patients receiving macrolide antibiotics, since they may inhibit pimozide metabolism. Two sudden deaths have been reported when clarithromycin was added to ongoing therapy.
Pimozide prolongs the QT interval, thus predisposing patients to fatal cardiac arrhythmias. An electrocardiogram monitoring is therefore recommended.
Pimozide is already contraindicated in patients with congenital QT prolongation, or in association with other drugs that prolong the QT interval (e.g other antipsychotics, some cardioactive agents).

References:

WHO Drug Information 1997; 11(3):141
Reviewed: 04/1998

Protease inhibitors (antiviral)
Hyperglycemia

An increase of blood glucose or the appearance of overt diabetes has been seen with saquinavir, indinavir, ritonavir, nelfinavir. Symptoms related to hyperglycemia (thirst, weight loss, urinary frequency, fatigue, itch) appeared 10 weeks after the onset of the therapy, as an average, but in some cases just a few days after the first dosing.
The positive benefit/risk ratio of these products in HIV patients, however, is not questioned, according to the FDA.

ADR DATABASE

References:
Br J Psychiatry 1995; 167: 374-379
BMJ 1998; 316: 1105-1106
Reviewed: 02/1999

Paroxetine (antidepressant)

Discontinuation reactions

References:

Clin Drug Invest 1998; 15: 61-63
Reviewed: 06/1998

Penicillamine (chelating agent)

Progression of scleroderma

A 58-Year old patient with recent sclerodactyly + Raynaud's phenomenon, developed a rapidly progressive skin thickening, followed by acute renal failure four months later as a consequence of a haemolytic-uraemic syndrome, after a treatment with penicillamine and prednisone.

References:

Am J Cardiol 1998;81(4): 523
Reviewed: 06/1998

Perindopril (antihypertensive)

Lingual angioedema

A case of severe lingual oedema and airway compromise was reported with perindopril, as a syndrome of angioedema. This kind of reaction is known to occur with all ACE-inhibitors.

References:

Info Fran Lakemedelsverket 1997; 4
Reviewed: 04/1998

Pertussis vaccine (vaccine)

Pharmacovigilance data

After the first-year use in Sweden of a combined pertussis vaccine (Infanrix â), there were 89 reports of adverse reactions, mainly fever, skin reactions, or hypotonic-hyporesponsive episodes; seldom restlessness, pain, cramps, and two cases of muscle hypotonia.

References:

Australian ADR Bulletin 1997; 16: 10
Reviewed: 04/1998

Pethidine (opioid analgesic)

Convulsions

35 reports of convulsions with pethidine, sometimes in combination with other drugs, were received in Australia since 1975.

References:

Wyeth Ayerst; June 26, 1998
Reviewed: 07/1998

Phendimetrazine (anorexigen)

Warnings

Warnings of possible valvular irregularities and primary pulmonary hypertension with phendimetrazine were issued by the manufacturer. Primary pulmonary hypertension - a rare, but frequently fatal disease - has been found to occur with increased frequency in patients receiving anorexigens.

References:

WHO Drug Information 1997; 11(4): 251-52
Reviewed: 04/1998

Phenolphtalein (laxative)

Carcinogenicity

Phenolphtalein laxatives were proposed for a ban on the OTC market in the USA, after a review of its carcinogenicity studies in rodents and mice. The doses that produced cancer were 30 -100 times higher than the recommended dose in humans.

References:

WHO Pharmaceutical Newsletter N° 3-4, 1997
Reviewed: 12/1997

Pimozide (antipsychotic)

Interactions with antibiotics

References:

WHO Drug Information 1997; 11(3):141
Reviewed: 04/1998

Protease inhibitors (antiviral)

Hyperglycemia

Return to the index of the database

The latest updates on ADRs are presented in the

News
on Adverse Drug Reactions

News
on Adverse Drug Reactions

Return to main page

ADR DATABASE

References: Br J Psychiatry 1995; 167: 374-379 BMJ 1998; 316: 1105-1106 Reviewed: 02/1999

Paroxetine (antidepressant)

Discontinuation reactions

References: Clin Drug Invest 1998; 15: 61-63 Reviewed: 06/1998

Penicillamine (chelating agent)

Progression of scleroderma

A 58-Year old patient with recent sclerodactyly + Raynaud's phenomenon, developed a rapidly progressive skin thickening, followed by acute renal failure four months later as a consequence of a haemolytic-uraemic syndrome, after a treatment with penicillamine and prednisone.

References: Am J Cardiol 1998;81(4): 523 Reviewed: 06/1998

Perindopril (antihypertensive)

Lingual angioedema

A case of severe lingual oedema and airway compromise was reported with perindopril, as a syndrome of angioedema. This kind of reaction is known to occur with all ACE-inhibitors.

References: Info Fran Lakemedelsverket 1997; 4 Reviewed: 04/1998

Pertussis vaccine (vaccine)

Pharmacovigilance data

After the first-year use in Sweden of a combined pertussis vaccine (Infanrix â), there were 89 reports of adverse reactions, mainly fever, skin reactions, or hypotonic-hyporesponsive episodes; seldom restlessness, pain, cramps, and two cases of muscle hypotonia.

References: Australian ADR Bulletin 1997; 16: 10 Reviewed: 04/1998

Pethidine (opioid analgesic)

Convulsions

35 reports of convulsions with pethidine, sometimes in combination with other drugs, were received in Australia since 1975.

References: Wyeth Ayerst; June 26, 1998 Reviewed: 07/1998

Phendimetrazine (anorexigen)

Warnings

Warnings of possible valvular irregularities and primary pulmonary hypertension with phendimetrazine were issued by the manufacturer. Primary pulmonary hypertension - a rare, but frequently fatal disease - has been found to occur with increased frequency in patients receiving anorexigens.

References: WHO Drug Information 1997; 11(4): 251-52 Reviewed: 04/1998

Phenolphtalein (laxative)

Carcinogenicity

Phenolphtalein laxatives were proposed for a ban on the OTC market in the USA, after a review of its carcinogenicity studies in rodents and mice. The doses that produced cancer were 30 -100 times higher than the recommended dose in humans.

References: WHO Pharmaceutical Newsletter N° 3-4, 1997 Reviewed: 12/1997

Pimozide (antipsychotic)

Interactions with antibiotics

References: WHO Drug Information 1997; 11(3):141 Reviewed: 04/1998

Protease inhibitors (antiviral)

Hyperglycemia

Return to the index of the database The latest updates on ADRs are presented in the Newson Adverse Drug Reactions

Newson Adverse Drug Reactions

References:
Br J Psychiatry 1995; 167: 374-379
BMJ 1998; 316: 1105-1106
Reviewed: 02/1999

References:

Clin Drug Invest 1998; 15: 61-63
Reviewed: 06/1998

References:

Am J Cardiol 1998;81(4): 523
Reviewed: 06/1998

References:

Info Fran Lakemedelsverket 1997; 4
Reviewed: 04/1998

References:

Australian ADR Bulletin 1997; 16: 10
Reviewed: 04/1998

References:

Wyeth Ayerst; June 26, 1998
Reviewed: 07/1998

References:

WHO Drug Information 1997; 11(4): 251-52
Reviewed: 04/1998

References:

WHO Pharmaceutical Newsletter N° 3-4, 1997
Reviewed: 12/1997

References:

WHO Drug Information 1997; 11(3):141
Reviewed: 04/1998

Return to the index of the database

The latest updates on ADRs are presented in the

News
on Adverse Drug Reactions

News
on Adverse Drug Reactions